Like many other businesses, clinical research also has its imperfections and inefficiencies. Clinical research involves many different parties: research sites, sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these parties play a significant role in the clinical research field.
As clinical research gets bigger and more evolved day by day, so does the need to fix the faulty areas. With the constant growing number of trials, the research industry urgently needs help!
Helpful information for sponsors: How to best spend your resources and avoid ...TrialJoin
Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is ‘’important’’ is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost!
Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive.
Resolving Sponsors’ Objections in Clinical TrialsTrialJoin
In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research.
Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before you’re officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what you’ve stated in the questionnaire is actually true in practice.
However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers.
Finding study leads, sharing them among sites and avoiding the enrollment of ...TrialJoin
Finding new study leads is always a good thing, especially for new clinical research sites. In many cases, there can be multiple research sites in one area. When this occurs, a couple of problems might arise. First, sometimes sites share the contact information of project managers to other sites, and second, some patients can get enrolled in more than one site for the same study.
In this article, we’ll tell you if sharing study leads is something that can be done without consequences, and we’ll also elaborate on the topic of avoiding duplicate patients. Even though it sounds complicated, there are simple solutions that can help you deal with these two types of situations.
Clinical Project Manager: Leading Causes of Problem Solving InefficienciesTrialJoin
A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPM’s role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc.
Patient retention challenges and the best ways to solve themTrialJoin
As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study.
Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not.
Seeing the high number of sites who face different problems with patient retention, we’ll give you an idea of what are the most common challenges you might face and how to fix them as much as possible.
Maintaining high levels of motivation and commitment of your clinical researc...TrialJoin
Clinical research projects usually have longer duration periods, so it’s not surprising that your research team can start losing focus and motivation after some time. Maintaining high levels of motivation, engagement, and commitment from the PI, coordinator, and all other individuals involved in research is extremely important for a successful project. This means that you will need to maintain the engagement of each individual separately as well as the whole team. Bringing back this focus and attention can sometimes be a big challenge for CRAs, sponsors or CROs.
Seeing how this problem is so common in the research community and how many people are constantly struggling with this question, we’ve decided to help you reach your best potential by showing you how to increase and maintain your team’s motivation and engagement in your research.
Most Common Clinical Research Site Worries and ComplaintsTrialJoin
All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
New Drug Application - How to Speed Up FDA ApprovalTrialJoin
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end?
After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here we’ll discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved.
Helpful information for sponsors: How to best spend your resources and avoid ...TrialJoin
Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is ‘’important’’ is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost!
Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive.
Resolving Sponsors’ Objections in Clinical TrialsTrialJoin
In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research.
Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before you’re officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what you’ve stated in the questionnaire is actually true in practice.
However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers.
Finding study leads, sharing them among sites and avoiding the enrollment of ...TrialJoin
Finding new study leads is always a good thing, especially for new clinical research sites. In many cases, there can be multiple research sites in one area. When this occurs, a couple of problems might arise. First, sometimes sites share the contact information of project managers to other sites, and second, some patients can get enrolled in more than one site for the same study.
In this article, we’ll tell you if sharing study leads is something that can be done without consequences, and we’ll also elaborate on the topic of avoiding duplicate patients. Even though it sounds complicated, there are simple solutions that can help you deal with these two types of situations.
Clinical Project Manager: Leading Causes of Problem Solving InefficienciesTrialJoin
A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPM’s role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc.
Patient retention challenges and the best ways to solve themTrialJoin
As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study.
Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not.
Seeing the high number of sites who face different problems with patient retention, we’ll give you an idea of what are the most common challenges you might face and how to fix them as much as possible.
Maintaining high levels of motivation and commitment of your clinical researc...TrialJoin
Clinical research projects usually have longer duration periods, so it’s not surprising that your research team can start losing focus and motivation after some time. Maintaining high levels of motivation, engagement, and commitment from the PI, coordinator, and all other individuals involved in research is extremely important for a successful project. This means that you will need to maintain the engagement of each individual separately as well as the whole team. Bringing back this focus and attention can sometimes be a big challenge for CRAs, sponsors or CROs.
Seeing how this problem is so common in the research community and how many people are constantly struggling with this question, we’ve decided to help you reach your best potential by showing you how to increase and maintain your team’s motivation and engagement in your research.
Most Common Clinical Research Site Worries and ComplaintsTrialJoin
All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
New Drug Application - How to Speed Up FDA ApprovalTrialJoin
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end?
After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here we’ll discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved.
Standard of Care Costs vs Study-Related CostsTrialJoin
In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When we’re talking about budgeting for a study, there are many separate items and things to be considered.
One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where it’s required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study.
Negotiating Clinical Research Budgets: Most Commonly Neglected ItemsTrialJoin
As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, we’ll teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study.
Essentials for Setting up a New Clinical Research CenterTrialJoin
This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor who’s interested in this option, we imagine that you’ve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and you’re already familiar with everything that clinical research entails, then you’re in a good position to start your own clinical research center or research clinic.
The business side of clinical research: profit margins and cash flowTrialJoin
People who run their own research centers or people who are interested in opening one in the future will usually be interested in the business side of conducting a research.
Although clinical research is an important factor when it comes to the general advancement of medicine, it’s crucial to understand and see it as a business, because essentially, it is a business that has to be profitable in order to be successful.
For this reason, we’ve prepared for you a short presentation that will give you the necessary knowledge of the business aspect of a clinical research center.
What to Do When There Are Adverse Events and Serious Adverse EventsTrialJoin
Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that they’re aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, it’s expected that as some point, some patients will experience adverse events or even serious adverse events.
At the site level, it’s important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when it’s a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions are crucial in case of such situations.
Most Common Clinical Research Site Worries and ComplaintsAnand Butani
All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
Explaining the Different Types of Routine Monitoring VisitsTrialJoin
In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRA’s tasks include on-site visits and ensuring compliance, subjects’ safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesn’t have to be a doctor or a medical professional. It’s enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training.
Helpful information on getting a clinical research job as a craTrialJoin
Clinical research is nowadays considered to be a fast-growing business, so many people are trying to look for ways to enter. There are many work positions in a clinical research facility, all depending on your experience and qualifications.
If you’re reading this, then probably you’re also interested in getting a clinical-research-related job position. And that’s great because this article is exactly for you!
Next, we’ll help you prepare for a job interview in clinical research, no matter which position you’re applying for! People who are interested in this field, are usually trying to get a job as a study coordinator, a CRA, or a research assistant. However, the strategies and tips we’ll give you can be applied to any research-related job!
Best recruitment strategies for elderly patients in clinical trialsTrialJoin
Clinical research breakthroughs would be impossible without people who agree to participate. Depending on the nature of the research that’s being conducted, different types of patient population are needed. Even though some research conditions and treatments might apply only to the younger population, most of them will require both younger and older people, since the variety of these different age groups will provide better study results. Another reason why elderly patients are much-needed participants in clinical research is the fact that approximately one-third of all medications are consumed by them. Taking into consideration that people over 65 consist only 13% of the population (more or less), one-third of all medication being used by them is a large number. For this reason, elderly patients are invaluable in clinical research.
New Drug Application: How to Speed Up FDA ApprovalAnand Butani
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug.
Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end?
Coupling customer journey maps with twitterAli Anani, PhD
The presentation suggests a new strategic canvas by combining customer journey maps with information mined from social media. Using a case study the merit of marrying social media to customer pain points becomes obvious and provides management with excellent tools to handle complaints efficiently and timely manners.
Presented at Predictive Analytics Innovation Summit, Chicago 2017 #PAChicago
https://theinnovationenterprise.com/summits/predictive-analytics-innovation-summit-chicago-2017/speakers
This presentation centers on currently published findings focused on the use of predictive analytics in healthcare venues of sports medicine and orthopedic rehabilitative settings. Aspects of data access via national patient registries as well as nascent applications of machine learning will also be covered. An example of one approach of incorporating a model of assessment, evidence-based practice, treatment augmentation, and resultant outcome evaluation will be provided as well.
Please be in touch
http://DrChrisStout.com
Mosio's Clinical Trial Patient Recruitment and Retention Ebook (First Edition)Mosio
The first edition of Mosio's patient recruitment and retention ebook contains 68 tips and examples from clinical research industry professionals on ways to improve efforts to recruit, retain and engage clinical trial patients.
To get access to a free download of the 2nd Edition, visit http://www.mosio.com/prebook
For more information on how you can improve patient engagement while increasing workflow efficiencies in communicating with study participants using two-way text messaging, please visit us at http://www.mosio.com
Standard of Care Costs vs Study-Related CostsTrialJoin
In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When we’re talking about budgeting for a study, there are many separate items and things to be considered.
One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where it’s required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study.
Negotiating Clinical Research Budgets: Most Commonly Neglected ItemsTrialJoin
As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, we’ll teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study.
Essentials for Setting up a New Clinical Research CenterTrialJoin
This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor who’s interested in this option, we imagine that you’ve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and you’re already familiar with everything that clinical research entails, then you’re in a good position to start your own clinical research center or research clinic.
The business side of clinical research: profit margins and cash flowTrialJoin
People who run their own research centers or people who are interested in opening one in the future will usually be interested in the business side of conducting a research.
Although clinical research is an important factor when it comes to the general advancement of medicine, it’s crucial to understand and see it as a business, because essentially, it is a business that has to be profitable in order to be successful.
For this reason, we’ve prepared for you a short presentation that will give you the necessary knowledge of the business aspect of a clinical research center.
What to Do When There Are Adverse Events and Serious Adverse EventsTrialJoin
Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that they’re aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, it’s expected that as some point, some patients will experience adverse events or even serious adverse events.
At the site level, it’s important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when it’s a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions are crucial in case of such situations.
Most Common Clinical Research Site Worries and ComplaintsAnand Butani
All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
Explaining the Different Types of Routine Monitoring VisitsTrialJoin
In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRA’s tasks include on-site visits and ensuring compliance, subjects’ safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesn’t have to be a doctor or a medical professional. It’s enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training.
Helpful information on getting a clinical research job as a craTrialJoin
Clinical research is nowadays considered to be a fast-growing business, so many people are trying to look for ways to enter. There are many work positions in a clinical research facility, all depending on your experience and qualifications.
If you’re reading this, then probably you’re also interested in getting a clinical-research-related job position. And that’s great because this article is exactly for you!
Next, we’ll help you prepare for a job interview in clinical research, no matter which position you’re applying for! People who are interested in this field, are usually trying to get a job as a study coordinator, a CRA, or a research assistant. However, the strategies and tips we’ll give you can be applied to any research-related job!
Best recruitment strategies for elderly patients in clinical trialsTrialJoin
Clinical research breakthroughs would be impossible without people who agree to participate. Depending on the nature of the research that’s being conducted, different types of patient population are needed. Even though some research conditions and treatments might apply only to the younger population, most of them will require both younger and older people, since the variety of these different age groups will provide better study results. Another reason why elderly patients are much-needed participants in clinical research is the fact that approximately one-third of all medications are consumed by them. Taking into consideration that people over 65 consist only 13% of the population (more or less), one-third of all medication being used by them is a large number. For this reason, elderly patients are invaluable in clinical research.
New Drug Application: How to Speed Up FDA ApprovalAnand Butani
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug.
Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end?
Coupling customer journey maps with twitterAli Anani, PhD
The presentation suggests a new strategic canvas by combining customer journey maps with information mined from social media. Using a case study the merit of marrying social media to customer pain points becomes obvious and provides management with excellent tools to handle complaints efficiently and timely manners.
Presented at Predictive Analytics Innovation Summit, Chicago 2017 #PAChicago
https://theinnovationenterprise.com/summits/predictive-analytics-innovation-summit-chicago-2017/speakers
This presentation centers on currently published findings focused on the use of predictive analytics in healthcare venues of sports medicine and orthopedic rehabilitative settings. Aspects of data access via national patient registries as well as nascent applications of machine learning will also be covered. An example of one approach of incorporating a model of assessment, evidence-based practice, treatment augmentation, and resultant outcome evaluation will be provided as well.
Please be in touch
http://DrChrisStout.com
Mosio's Clinical Trial Patient Recruitment and Retention Ebook (First Edition)Mosio
The first edition of Mosio's patient recruitment and retention ebook contains 68 tips and examples from clinical research industry professionals on ways to improve efforts to recruit, retain and engage clinical trial patients.
To get access to a free download of the 2nd Edition, visit http://www.mosio.com/prebook
For more information on how you can improve patient engagement while increasing workflow efficiencies in communicating with study participants using two-way text messaging, please visit us at http://www.mosio.com
Tricks of the Trade: Patient Recruitment & Retention for Different Study TypesImperial CRS
In efforts to raise the bar for medical advancement, clinical trials are growing increasingly complex. This complexity, more often than not, leads to costly delays in enrollment. In this ebook, we'll take a look at 4 case studies for different study types, and examine the unique factors to consider during planning.
Smart medical practice marketing can help you grow a stable practice, have more satisfied patients, and see better reimbursements.
You no longer have to rely on insurance companies as your sole gateway for new patients. Networking and digital marketing provide you with an abundance of resources that will not only make you more appealing to prospective patients, but more personable as well.
How to Start, Run and Manage a Hospital Successfully by Dr.Mahboob ali khan Phd Healthcare consultant
The purpose of this paper is to give a brief outline of the pre-planning and strategic thinking in which an entrepreneur might consider before investing in or starting up a new hospital in the developing world.
There are numerous examples of hospital startups that were ill-conceived or poorly planned and have resulted in either a hospital that was partially constructed and abandoned or were completed and within two years failed in profitability and now sit idle. Other examples exist of underperforming assets. What went wrong? What could the investors have done to decrease their investment risk and increase the chances of the hospital being successful?Globalization of Healthcare.
4 Internal Environmental Analysis and Competitive AdvantageTh.docxgilbertkpeters11344
4 Internal Environmental Analysis and Competitive Advantage
“The biggest problem with health care isn't with insurance or politics. It's that we're measuring the wrong things the wrong way.”
— ROBERT S. KAPLAN AND MICHAEL PORTER
Introductory Incident
Two-Way Communication and Competitive Advantage
Health care organizations are notorious for one-way communication. When communicating with patients and communities, health care organizations typically employ traditional techniques such as broadcast advertising, distribution of educational materials prepared for a variety of audiences, and similar methods.
A few organizations, however, have recognized the possibilities created by social media and understand that health is extremely personal and materials prepared for mass audiences rarely address the unique concerns of individual patients. Moreover, when patients must access the
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health care system they are unprepared for the experience, lost in the confusion of the high-technology environment of health care, and grasping for information. Social media has done much to change this situation. Patients can easily communicate with people across the globe, share common experiences and fears, discover the personal experiences faced by others, and access all types of medical information.
Unfortunately, many health care organizations choose to use social media as just another means of one-way communication. In some cases most of the organization's posts are designed to promote the hospital or medical practice rather than address patient issues and concerns. A few organizations, recognizing this temptation, develop policies that “no more than a certain percentage” of posts can be used for promotion purposes. At Inova Health System an effort is made to ensure that 80–90 percent of its posts address patient health rather than promoting the System.
Inova has made serious attempts to use social media effectively. It has created Facebook communities in specific areas such as wellness, pediatric care, bariatric surgery, and so on. Attempts are made to encourage users to trust Inova as a supplier of valuable health information. Information can be shared about the System but only after trust is built and the interests of the organization are consistent with the interests of the communities.
It is essential to remember why social media is important. The goal is to connect with friends and build communities around common interests and to share information better and faster. Furthermore, communicating poorly is almost as bad as not communicating. The quality of posts is more important than the quantity. Because real-time communication is so exciting we frequently confuse social media overuse with proper use. Designing social media that is honest and transparent is the important determinant of how likely individuals are to follow and participate in an organization's communication efforts.
Some general recommendations for health care organizations to .
White Paper written on behalf of athenahealth regarding sources of revenue erosion in medical practices. I researched and wrote this paper while on contract with athenahealth in 2008, in the midst of the financial collapse on Wall Street.
10 ten best, average and worst Points of Pharmaceutical marketingAnjum Iqbal
10 ten best, average and worst Points of Pharmaceutical marketing.
Basically this presentation is related to the pharmaceutical marketing. . . that which type of strategies become best , worst and average for the pharmaceutical marketing.
Ahead of the marcus evans Evolution Summit 2022, read here an interview with Kristine Koontz discussing what it takes for sponsors and vendors to have a mutually beneficial relationship.
New Technologies Close the Recruitment GapJohn Reites
Applied Clinical Trials (15Sep2014)
Optimizing Patient Enrollment in Global Clinical Trials
Overcoming enrollment issues due to changes in country requirements, how to create less burdensome global protocols with the patient in mind, how to decrease the cost of medicines and care, how to incorporate local assessments/reduce travel, mobile technologies used in global enrollment procedures and the potential of registries to enhance recruitmentless
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Financing - Investigator Payment Models & Best Budget PracticesTrialJoin
Aside from being a vital part to medical advancement, a clinical trial is a complex and expensive business which requires great planning and strategy.
One big part of a successful trial are the finances. Financing clinical trials is a task that involves careful planning, anticipation, and negotiation of costs, budgets, and compensation to investigators. Taking into consideration the great number of items, procedures, protocols, subjects, and visits, it can be challenging to not miss or forget an item when you're preparing your budget. Managing to get the necessary budget that you need for covering all costs of conducting a trial requires careful anticipation and great negotiation skills. When negotiating your budget and explaining all the costs and expenses to sponsors, you have to take into consideration the costs for paying your investigators.
In this article, we'll explain all the different payment models for investigators as well as give you some great tips and techniques to help you allocate and negotiate your budget in a better way. Doing this will help you work with a profit, while still being able to cover all your trial expenses.
Legal Compensation for Referring Doctors in Clinical TrialsTrialJoin
As we all know, the best way for clinical research sites to recruit patients is through patient referrals. These referrals usually come either from the PI (principal investigator) or more often from other referring physicians.
Physicians who refer patients to your site can work independently or work as your sub-investigators. Now, when these physicians are your sub-Is you’ll have to find the proper way to compensate them. Many sites experience challenges related to sub-I compensation for referrals.
The way in which you choose to compensate these sub-investigators for referring patients to you should be legal and it shouldn’t interfere with “Anti-Kickback Statute” or the IRB.
So, how can clinical research sites do this? How do we compensate sub-Is in a legal way? We’re here to tell you that there are actually many ways in which this can be done. Below, we’ll give you the best solutions to this common problem.
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...TrialJoin
No matter if you’re reading this because you aspire to become a CRA, or you’re a study coordinator, or maybe you’re part of a research site, learning about feasibility surveys and questionnaires is important for everyone that’s in any way involved in clinical trials.
In this article, we’ll try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsor’s decision of awarding you the study.
Regulating the Workload of Your Clinical Research Coordinator (CRC)TrialJoin
A CRC (clinical research coordinator) is one of the most important people regarding clinical trials. He/she is the person who’s in charge of conducting the clinical trial, under the guidance of the PI (principal investigator). As the people responsible for coordinating all the activities on site, CRCs can sometimes carry a huge workload. This can quickly become a big problem not only for the CRC but also for everyone else involved in the study.
Determining the right workload for your CRC is one of the most important actions that you (as a site owner or PI) should take. Ideally, a CRC should work 4 to 6 effective hours per day. However, you will notice that there will be periods of time when the CRC has to work more than 8 hours but also periods when he/she will be free most of the days. In this article, we’ll help you find the right balance so that your CRC isn’t too overworked or underworked.
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowTrialJoin
A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional who’s responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice.
Whether you already are a CRA or you’re trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, we’ll explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits.
Differences Between Satellite Sites and Multi Site Research ClinicsTrialJoin
In the clinical research industry, there are two terms that we commonly encounter: satellite sites and multi sites. Although these two might sound the same, they’re not! The concept of a satellite site is much different than multi-site clinics. However, we can still see a large part the industry that is confusing these two terms.
Below, we’ll explain to you the difference between a satellite site and multi-site clinics.
Explaining the importance of a database lock in clinical researchTrialJoin
One of the most crucial aspects of research is clinical data management or CDM. Proper CDM will generate results with excellent quality, integrity, and reliability. Quality data is essential in order to support the final conclusions of a certain study.
The person responsible for this area of research is called a clinical data manager. This job position can be filled by a PI, a study coordinator, or a CRA. No matter who fills this position at your site, data management has to be done promptly and correctly in order to generate the best results. Aside from all the other reasons why data management is so important, it’s also what determines the future IP (investigational product) development.
Compensation for your PI explained in depthTrialJoin
Clinical research plays a crucial role in the medical advancement, and a large part of this role is due to the efforts of investigators. For this reason, sponsors and CROs are encouraged to offer fair compensation to the PIs responsible for conducting their studies.
A PI or a Principal Investigator is the lead researcher in a clinical trial who takes direct responsibility for conducting and leading the trial, taking care of the safety and efficacy of the investigational product (IP), and caring about the subjects’ well-being.
Being such an important part of clinical research, a PI has to be well compensated. Finding the best compensation method and amount that will be fair for both the research site and the PI can be pretty challenging, especially for new and inexperienced sites. It’s because of this that we’ve decided to give you an idea of the ways in which you can compensate your PI, as well as the fair percentage or amount as compensation.
Best practices for maintaining and storing essential documents in clinical re...TrialJoin
The complexity of a clinical research trial involves keeping and storing multiple essential documents that are necessary for a successful trial and quality results. The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity.
Regulations in clinical research: obligations and responsibilities of investi...TrialJoin
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
CTMS for your site's financial activitiesTrialJoin
Accurately tracking and managing financials is important for your site's successful conducting of a trial, as well as the site's general success in the long-run.
There are 2 possible outcomes by not taking proper care of your site's financial activities, either you're losing unaccounted money or you're spending a lot of unnecessary time and effort to make sure you're not missing anything.
Sites nowadays use electronic systems for financial management such as a CTMS (clinical trial management system).
Most of you who are already involved or familiar with clinical research are probably aware that there are different phases in conducting a clinical study: Phase I, Phase II, Phase III and Phase IV. Another thing you might be familiar with is that Phase I studies can be particularly hard to get, especially for new research sites.
How different are Phase I studies in practice?
To answer this question and many more, we’ve decided to clarify some common misconceptions regarding Phase I trials. We will help you understand what it means to conduct a Phase I trial and how profitable these trials will be for your site.
Drug accountability: an important aspect of clinical researchTrialJoin
Drug accountability is an interesting topic related to clinical research, both for the CRAs and for the clinical research sites. Even though drug accountability isn’t a task that should be performed by the CRA, he or she is still responsible for monitoring and making sure that the site is correctly performing every task related to this field.
The topic of drug accountability is especially important in regards to quality data as well as for patient safety. For this reason, we’ll give you an in-depth explanation of everything that drug accountability entails.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Increasing the quality of clinical research: best ways to solve the most common inefficiencies
1. Increasing the Quality of Clinical Research:
Best Ways to Solve the Most Common
Inefficiencies
2. Introduction
Like many other businesses, clinical research also has its imperfections and
inefficiencies. Clinical research involves many different parties: research sites,
sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these
parties play a significant role in the clinical research field.
As clinical research gets bigger and more evolved day by day, so does the need
to fix the faulty areas. With the constant growing number of trials, the research
industry urgently needs help!
In this article, we’ll talk about some of the most common clinical trial
inefficiencies and imperfections, and the best ways to fix this and improve the
field of clinical research. No matter if you’re reading this as a site owner, a
sponsor, or a CRO, each individual/organization can play a huge role in
improving clinical research. Doing your part and contributing to this cause will
make things easier for everyone involved. Decreasing clinical research
inefficiencies will allow patients to gain access to new and better treatments
much faster! And in the end, that’s all that clinical research aims to achieve!
2
3. Most Common Clinical Research Inefficiencies
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Research
Sites
Sponsors
PIs; CROs
Recruitment
Agencies
CRCs
Clinical
Research
Involved
Parties
Most Common Clinical
Research Inefficiencies:
- Recruitment
Inefficiencies;
- Awareness
Inefficiencies;
- Other Inefficiencies;
5. #1 - Sites Not Doing Enough Work
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A common problem with clinical research sites is
the fact that they’re not willing to put in the
amount of work necessary for a successful
enrollment.
Placing an ad somewhere or printing out materials won’t
be enough most of the times. What sites are usually
missing is being proactive and having a human factor.
The proven best way to enroll patients is through
physician referrals.
Whether this is going to be from your own PI’s office or
from other physicians it makes no difference.
6. #2 - Relying Solely on Recruitment Agencies
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While some new recruitment agencies can offer good prices for
their services, such as paying only for screened patients, most of
them are really overpriced. And being overpriced would be
acceptable if they actually deliver results, but, unfortunately,
most of the times they don’t!
Sites often make the mistake of hiring a third party (recruitment
agency) to do their recruitment and they leave everything to this.
If you’ve tried doing this, you probably know that it almost never
works! Recruitment agencies can be hired as an additional help
with recruitment, not as the only recruitment method! The fault
in recruitment companies can be easily seen when we consider
the large number of them being opened every day while the
number of sites with successful enrollment remains the same.
This can clearly show you that recruitment companies are not
the best route to take!
No.of
Recruitment
Agencies
No.of
Successful
Enrollment
Sites
7. #3 - Reversing the Process of Acquiring a Site
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Usually, a sponsor will contract a CRO to find them a
site, and then the CRO will choose a site from their
network of sites they’ve already worked with.
However, these sites will usually not be able to meet
the sponsor’s enrollment needs. This is the
traditional method which so far isn’t working so
well. However, if your try to reverse this process,
you might see more success in enrolling patients.
What does this mean? Reversing the process means
that you will first start by finding a research-naive
physician who’s able to help you with research (by
being your PI) and convince him to do so, and then,
you’ll look through his database of patients to make
sure it’s large enough. Next, you’ll have to train the
PI in research, and finally, contract his site for the
study in the same therapeutic area.
In order to make this offer even more interesting, tell
the PI that the study will be conducted in his/her own
practice, which means that he’ll get even more benefits.
By doing this process in reverse, you will greatly
increase your chances of enrolling patients. Even
though CROs usually focus on sites that they’re
comfortable with or sites with experience, sometimes,
creating a brand new site with a PI who possesses a
large database of patients can work even better. It all
depends on the effort that staff members put in the
trial, so don’t be so quick in avoiding new sites!
8. #3 - Reversing the Process of Acquiring a Sitewww.trialjoin.com
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Sponsor
contracts CRO to
find them a site
CRO chooses a site
from their network
of familiar sites
Site has a PI that
doesn’t fit or doesn’t
have the needed
database of patients
Site tries to enroll
patients for the
study
FAILS!
1 2 3 4 5
Sponsor
contracts CRO to
find them a site
CRO finds a
research-naive
physician with the
right database
Physician is trained
in research and
becomes a PI
CRO contracts this
new site for the
study and site starts
enrolling patients
SUCCESS!
12345
11. #1 - Using Content Marketing
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Content marketing as a field entails creating
and sharing materials such as articles, blogs,
videos, and social media posts, with the goal
of educating people and stimulating their
interest in a specific service or product.
When you’re doing content marketing, you’re not specifically
promoting your brand or asking people to do something, but
only explaining them what you’re doing and giving them the
option to use your services. In the case of clinical research,
content marketing can be done to target specific conditions,
explaining those conditions, and then pointing out how a
clinical trial can help people who are affected. As an
educational tool, content marketing is a great way to raise
the awareness of research-naive people, which will in turn
raise the interest in people who are willing to enroll.
12. #2 - Educating Physicians
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Even though physicians have a medical background and
are dealing with medicine on a daily basis, most of them
are still research-naive. By educating them and raising
their awareness of research, they’ll be more willing to
refer patients to your site. Most physicians don’t even
consider clinical trials as a treatment option for some of
their patients in need, while the ones who are familiar
with research usually don’t have the right contacts or
relationships to do this. By teaching them what a clinical
trial entails, and even training them to work as your PIs
or sub-Is, they can agree to refer patients to you,
especially since they will also benefit from this - both
financially and as an experience.
13. #3 - Community Outreach
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Above, we mentioned the use of content
marketing as one of the best online ways and
marketing tools for raising the awareness of the
general population. However, we shouldn’t forget
traditional methods of bringing awareness which
include different types of community outreach,
face-to-face conversations, and word-of-mouth. In
order to do a community outreach, a site owner
or a CRO has to be proactive and go out to
different support groups, hospitals, local
physicians, and other facilities that provide
support for patients.
Promoting your trial and site in the real world
is irreplaceable!
Community
Outreach
word -of-
mouth
face-to-face
conversations
visits to
clinics and
health
centers
participation
in health
fairs & other
events
15. www.trialjoin.com Other Common Inefficiencies
15
Extended timelines and delays
Investigators giving up research
Longer study start-up time
Increasing costs$
Apart from the two groups above, there are also many other
smaller inefficiencies in research that you might want to
consider changing. No matter how small these might seem,
remember that clinical research is an expensive business, so
every single imperfection can cost a lot of money.
16. www.trialjoin.com
CONCLUSION
Improvements and increase in the efficacy of clinical trials will not be seen unless each respective party plays its role to change
something. As we’ve already established, the clinical research industry is facing a lot of problems that need to be addressed in order to
speed up the process of placing new and better treatments in the market. Regardless of the type of therapeutical area, each trial faces
the same problems: recruitment, lack of awareness, increasing costs, many delays in trial timelines, lack of interested physicians, etc.
Sponsors, CROs, and sites should work together in order to develop better ways and methods of resolving these issues. Doing this might
not be so simple because we can see that there isn’t one magical formula that will work for all sites. However, by trying different
techniques and methods, you will be able to find out what works best for you.
As a final note, we want to remind you that most research inefficiencies can be solved by putting more effort in patient
recruitment and educating and convincing physicians to get involved in research. Be proactive and start approaching
physicians, patients, and the whole population in general. Talk, educate, explain!
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