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
Digital communications bring opportunity and risk to the therapeutic relationship. Doctors and other health professionals can learn to collaborate in person and online to protect informed decision making. Modified slightly from a talk August 8 2019 at Brigham & Women's Hospital/Dana-Farber Cancer Institute.
When the Human Genome Project was declared complete back in 2003, there were high expectations set for genomic medicine. However, it has taken over a decade to begin moving from vision to reality. Today, the number of success stories remains relatively small, but they do stretch across the healthcare ecosystem, incorporating the prediction of drug responses, the diagnosis of diseases and the identification of targeted therapies. Stakeholders ranging from patients, healthcare providers and payers, researchers, diagnostic companies, policy-makers, life sciences businesses and governments now believe genomic medicine to be a potential game-changer
Hospitals are charged with the dual task of keeping patients well while also keeping patients safe. The two are inextricably linked, as patient safety concerns often tie directly into patient health concerns — hand hygiene, transitions of care and medication errors are a few such concerns that come to mind.Looking prospectively, these concerns, and many others, will flow into the next calendar year. Some of the patient safety issues are long established, and will remain in the forefront of healthcare's mind for years to come. Here, in no particular order, are 10 important patient safety issues for providers to consider in the upcoming year.
Digital communications bring opportunity and risk to the therapeutic relationship. Doctors and other health professionals can learn to collaborate in person and online to protect informed decision making. Modified slightly from a talk August 8 2019 at Brigham & Women's Hospital/Dana-Farber Cancer Institute.
When the Human Genome Project was declared complete back in 2003, there were high expectations set for genomic medicine. However, it has taken over a decade to begin moving from vision to reality. Today, the number of success stories remains relatively small, but they do stretch across the healthcare ecosystem, incorporating the prediction of drug responses, the diagnosis of diseases and the identification of targeted therapies. Stakeholders ranging from patients, healthcare providers and payers, researchers, diagnostic companies, policy-makers, life sciences businesses and governments now believe genomic medicine to be a potential game-changer
Hospitals are charged with the dual task of keeping patients well while also keeping patients safe. The two are inextricably linked, as patient safety concerns often tie directly into patient health concerns — hand hygiene, transitions of care and medication errors are a few such concerns that come to mind.Looking prospectively, these concerns, and many others, will flow into the next calendar year. Some of the patient safety issues are long established, and will remain in the forefront of healthcare's mind for years to come. Here, in no particular order, are 10 important patient safety issues for providers to consider in the upcoming year.
Spotlight On... Medical CommunicationsCOUCH Health
Pharma is unique as an industry in the way that there are three equal voices that need to be heard – patients’, HCPs’ and pharma’s.
As pharma brands, it’s all too easy to talk more than we listen. But in order to ensure what we say is meaningful, we need to be able hear what patients and HCPs have to say.
The good news is that there are many ways that pharma can help give others a voice. Which is exactly what we want to see more of in 2017.
And so, 2017's first edition of Spotlight On…is dedicated to discussing all the strategies and tactics we can use to create this three-way conversation. From taking a patient-centric approach and understanding patient behaviour, to creating personas and using personalisation effectively, we explore how you can ensure everyone is heard.
By doing this, we’re ultimately improving engagement between pharma and our target audience. So everyone’s a winner!
Patient engagement in medical device studiesCOUCH Health
Not only will the industry see changes with the EU MDR, but we're glad that patients will recognise changes for the better, too. Patients can expect to make more informed decisions before using medical devices, as more information will become publicly available. And we think this is a big step in the right direction! Read more about our thoughts on involving patients more in the medical device clinical trial process:
From Patients to ePatients Driving a new paradigm for online clinical collabo...ddbennett
CareTech eHealth Innovation Series
From Patients to ePatients Driving a new paradigm for online clinical collaboration and health management
David Bennett, SVP, Interactive Solutions
StayWell Custom Communications
Anthony Chipelo, Director, Portal Strategies
CareTech Solutions
Engaging the hard_to_engage_through_innovative_channelsGeorge Van Antwerp
A presentation from the Care Continuum Alliance (CCA) that I gave with Aetna 2 years ago. I found it posted online and decided to share it.
http://www.carecontinuumalliance.org/theforum11/Presentations/Engaging_the_Hard_to_Engage_Through_Innovative_Channels.pdf
This presentation from the 2014 ASHRM Conference analyzes the legal, regulatory and clinical risks related to meaningful consent and offers ways to mitigate them.
What do MDs think about patient engagement? What's the gap between today's healthcare marketplace and the marketplace of the future? What is pathway to patient engagement?
Join us for our 4-part webinar series with the latest real time market intelligence on patient engagement.
Let's Get Personal: How to Change Your Marketing Approach & Get Noticeddomain .ME
Natasa Djukanovic, Sales & Markering Manager at .ME, presented at NMX 2013 in Las Vegas!
Over the last decade or so, the focus in marketing has shifted from the product to the consumer – almost everything, from sports shoes to M&M’S, is getting a personalized look, feel and flavor. As we each claim our own piece of Internet real estate with our business or blog, it is crucial to capture the attention of readers and customers, and stand out from the crowd.
This evolution in marketing will be presented using the best examples from the industry, along with carefully selected tips and trips to help connect with your target audience in a powerful and personal way. Did we mention there will be pictures of cute animals and food?
Spotlight On... Medical CommunicationsCOUCH Health
Pharma is unique as an industry in the way that there are three equal voices that need to be heard – patients’, HCPs’ and pharma’s.
As pharma brands, it’s all too easy to talk more than we listen. But in order to ensure what we say is meaningful, we need to be able hear what patients and HCPs have to say.
The good news is that there are many ways that pharma can help give others a voice. Which is exactly what we want to see more of in 2017.
And so, 2017's first edition of Spotlight On…is dedicated to discussing all the strategies and tactics we can use to create this three-way conversation. From taking a patient-centric approach and understanding patient behaviour, to creating personas and using personalisation effectively, we explore how you can ensure everyone is heard.
By doing this, we’re ultimately improving engagement between pharma and our target audience. So everyone’s a winner!
Patient engagement in medical device studiesCOUCH Health
Not only will the industry see changes with the EU MDR, but we're glad that patients will recognise changes for the better, too. Patients can expect to make more informed decisions before using medical devices, as more information will become publicly available. And we think this is a big step in the right direction! Read more about our thoughts on involving patients more in the medical device clinical trial process:
From Patients to ePatients Driving a new paradigm for online clinical collabo...ddbennett
CareTech eHealth Innovation Series
From Patients to ePatients Driving a new paradigm for online clinical collaboration and health management
David Bennett, SVP, Interactive Solutions
StayWell Custom Communications
Anthony Chipelo, Director, Portal Strategies
CareTech Solutions
Engaging the hard_to_engage_through_innovative_channelsGeorge Van Antwerp
A presentation from the Care Continuum Alliance (CCA) that I gave with Aetna 2 years ago. I found it posted online and decided to share it.
http://www.carecontinuumalliance.org/theforum11/Presentations/Engaging_the_Hard_to_Engage_Through_Innovative_Channels.pdf
This presentation from the 2014 ASHRM Conference analyzes the legal, regulatory and clinical risks related to meaningful consent and offers ways to mitigate them.
What do MDs think about patient engagement? What's the gap between today's healthcare marketplace and the marketplace of the future? What is pathway to patient engagement?
Join us for our 4-part webinar series with the latest real time market intelligence on patient engagement.
Let's Get Personal: How to Change Your Marketing Approach & Get Noticeddomain .ME
Natasa Djukanovic, Sales & Markering Manager at .ME, presented at NMX 2013 in Las Vegas!
Over the last decade or so, the focus in marketing has shifted from the product to the consumer – almost everything, from sports shoes to M&M’S, is getting a personalized look, feel and flavor. As we each claim our own piece of Internet real estate with our business or blog, it is crucial to capture the attention of readers and customers, and stand out from the crowd.
This evolution in marketing will be presented using the best examples from the industry, along with carefully selected tips and trips to help connect with your target audience in a powerful and personal way. Did we mention there will be pictures of cute animals and food?
Prezentacija Spark.me, regionalne konferencije posvećene Internetu, tehnologiji i biznisu, koja će se održati 26. i 27. septembra 2013. godine u hotelu Splendid (Crna Gora). Dobrodošli!
***
Presentation of Spark.me, a regional conference dedicated to Internet, technology and business, which will be held on September 26 & 27, 2013 in hotel Splendid (Montenegro). Welcome!
Curious about how premiums and deductibles work? Are you considering changing your deductible to save money in the short term? This infographic will answer your questions.
This slides provides general overview of the steps that needs to be undertaken in installing, using and interpreting Google Analytics and Webmaster Tools.
For more information, email info@rlcomm.org.
Building a great new app? Why not choose .me -- the most personal and memorable domain extension available.
Check out some great examples and services!
How do we see the healthcare's digital future and its impact on our lives?Jane Vita
"Healthcare is undergoing major changes spurred on by, but not limited to, technology.
Digitalisation is changing the way we think about health, what taking care of it really entails, our personal role in healthcare systems and the way we interact with technology in the context of health.
In many ways, we are entering a post-institutional age of increased personal responsibility, which presents healthcare service providers and other players in the field with major opportunities and great risks. Technology has the potential to empower people and help them become more active in the management of their and their families’ health. This will change the relationship of the patient and the caregiver in profound ways." Mirkka Länsisalo
A co-creation with Mirkka Läansisalo and Sala Heinänen, at Futurice.
Healthcare is undergoing major changes spurred on by, but not limited to, technology.
Digitalisation is changing the way we think about health, what taking care of it really entails, our personal role in healthcare systems and the way we interact with technology in the context of health.
In many ways, we are entering a post- institutional age of increased personal responsibility, which presents healthcare service providers and other players in the eld with major opportunities and great risks. Technology has the potential to empower people and help them become more active in the management of their and their families’ health. This will change the relationship of the patient and the caregiver in profound ways.
For thousands of years, humans moved their knowledge of medicine forward through informal, anecdotal, experimental, sometimes very dangerous methods. It was not until the mid-20th century that organized clinical research trials became a central element of medical progress, and since that time, millions of people around the world have benefited from the careful, safe study and approval of medications and other treatment methods for negative health conditions of all types.
Clinical trials are necessary for medical research. Producing new medicines to the market depends on the strength of research organizations and drug companies to test and verify their work vigorously through their Clinical Trials, but finding people willing to participate is notoriously tricky.
Trendwatchers from around the world came together to identify the big shifts critical to pharmaceutical brands and healthcare marketers.
What's inside: 2016 will be the year an old debate reignites and simple digital tools fuel an incredible new era of clinical study. The patient journey will be rerouted and the tug of war at the point of care will get much more intense. Caregiving will approach a cliff, healthcare teams will get bigger, and patients will come to the exam room with new expectations. The science of motivation will face a crossroads and you’ll probably lose you Fitbit.
Similar to New Technologies Close the Recruitment Gap (20)
Virtual Visits by THREAD (www.THREADresearch.com)John Reites
The hybrid virtual approach: replacing on-site clinic visits with Virtual Visits using THREAD. Presented at DPharm on 24Sep2018 for Mobile in Clinical Trials.
4 Strategies to Influence Digital Health Approaches in Clinical Research StudiesJohn Reites
Drug Information Association (DIA) 2016 Conference presentation by John Reites on June 26, 2016. Session entitled; "Digital Health Debate" including this presentation on the four strategies to influence digital health approaches in clinical research studies.
Top 100 Influencers and Brands in Digital Health by OnalyticaJohn Reites
Research and report published by Onalytica on 06 May 2016. John Reites and others noted as top influencers in Digital Health within the report. Weblink: http://www.onalytica.com/blog/posts/digital-health-2016-top-100-influencers-and-brands/
Implement a Direct-to-Patient Approach to Increase Patient Engagement and Ret...John Reites
Article by MM&M (Medical, Marketing & Media) on 25 Mar 2015 with John Reites discussing direct-to-patient approaches to conduct innovation research models that increase engagement and retention.
Weblink: http://www.mmm-online.com/pharmaceutical/implement-a-direct-to-patient-approach-to-increase-patient-engagement-and-retention/article/405443/
Accelerate and Integrate Digital Health InnovationJohn Reites
4 strategies to influence and execute digital health approaches. Presented on 23 Mar 2016 by John Reites at the Data 4 Decisions Conference in Raleigh, NC.
Drug Information Association (DIA) Magazine (select article from Page 11 only) authored by John Reites on 14Dec2015.
Today’s consumers expect seamless, value-driven experiences when they engage with a brand. From buying products online, to getting text alerts about doctors’ appointments, to completing transactions via mobile apps, they assume every interaction will be painless and pleasant – and participating in a clinical trial is no exception.
People join these research studies to improve their health and contribute data for the care of others – and in exchange, they expect their research experience to be positive, accommodating of their time, and intuitive. If it’s not, the cost-benefit scenario can shift, and they may decide it’s not worth the effort.
Intrapreneural Innovation - Strategically and practically move innovative ide...John Reites
Presentation by John Reites at DIA Conference on 16Jun2015 in Washington, DC.
The word “innovation” has become synonymous with some of the most ground-breaking research and technologies our industry benefits from today. Innovation is now a required output in our companies and critical to the continued evolution of our business. Unfortunately, innovation is often impeded by false perceptions, lack of strategic planning, poor risk management and fear.
The reality is that innovation can progress forward incrementally and strategically to increase efficiency, engage supportive stakeholders and lead to mitigated risk-taking. Understanding how to ramp into innovation can support new approaches being implemented, measured and expanded upon.
In this session we will review strategies for how to action innovation within a company or research program based on experience gained from implementing successful pilots and novel study design approaches.
We will explore insights on how to:
• Develop a stage-gate plan with key stakeholder support to practically integrate innovation
• Effectively pilot solutions with a structure to scale if successful
• Set proper expectations from the start for all teams involved
• Define risks and measure success
• Generate a communication plan that promotes adoption and the value of innovation
These insights will be explained in the context of various case studies in which innovative approaches were implemented into action in research programs.
Presentation by John Reites on 08May2015 at the NCHICA Thought Leader Forum on Patient Generated Data in RTP, NC.
The future of health care delivery is connected, continuous, empowered, and personal. Digital capabilities are a foundational element to enable a successful shift to Connected Care and now many organizations are working through how to design, operationalize and sustain a digital care program that provides new and quality access to care to improve outcomes. In addition, organizations must determine how to ingest, analyze, and produce meaningful insight with new forms of data, specifically patient-generated data.
This panel will look at changes in access to care, recent trends in the market place, integration of patient-generated data into healthcare workflows, and the infrastructure (e.g., data lakes) needed to support these powerful new capabilities.
Real World Data - The New Currency in HealthcareJohn Reites
White paper published in June 2015 by CBI Life Sciences with interview insights from John Reites.
Real World Data (RWD) have become the bio/pharmaceutical industry’s treasure trove for information to inspire stakeholder decision-making. As an industry, professionals have increasingly been looking to RWD to not only assess the bene ts and risks of new medicines in clinical and real world settings, but also as a way to advise healthcare reimbursement decisions worldwide.
Engage and Retain Patients in Long-term Observational StudiesJohn Reites
Traditionally, real-world and late phase studies require sites to enroll, engage and retain patients and collect and record patient reported outcomes (PRO), which can be burdensome to both sites and patients. Overtime, sites and patients may lose motivation to participate, contributing to high patient dropout rates, increased study costs and site dissatisfaction. This session will focus on innovative approaches for effectively engaging and retaining patients in long-term studies, such as: identifying design and operational considerations with conducting long-term observational research, understanding site and patient retention challenges, and examining engagement strategies and opportunities for improving retention and compliance.
The Patient-Centered Clinical Trial: A New ParadigmJohn Reites
Patient centricity is no longer just viewed as an opportunity
solely for commercial pharma. In September 2014,
eyeforpharma brought together 100 US clinical leaders
to discuss the evolving role of patients in clinical trials.
The executive forum addressed the latest trends and
innovations in clinical trial management from a patientcentric
perspective, but it was the presence and involvement
of several patients and patient advocates that shaped the
discussion and expanded our thinking on the topic. Beyond
debating various practical questions, delegates from
pharma began to wonder how the necessary changes might
materialize under the organizational lens.
Recruitment Metrics from TogetherRA: A Study in Rheumatoid Arthritis Patients...John Reites
DIA poster presentation on May, 30, 2013 for a direct-to-patient RA patient study that collected ePRO, medical chart data and a biologic lab sample from 23andMe with integration for final analysis.
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Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
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In the DSM-5, all types of substance abuse and dependence have been
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effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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New Technologies Close the Recruitment Gap
1. September 15, 2014
New Technologies Close the Recruitment Gap
By Fred Gebhart
Newspaper ads, radio and television, posters, fliers, and other conventional patient recruitment strategies don’t seem
to work, producing familiar and depressing results. “Many patient recruitment companies are feeding patients into a
system that does not work very well,” said Paul Wicks, PhD, Vice President of Innovation at PatientsLikeMe.com, a
patient community website that partners with trial sponsors to boost enrollment. “In today’s world, it is about trial
participation, not trial recruitment. The confluence of technology and patient engagement can upgrade the clinical trial
experience and outcome.”
The clinical trial process relies on a triad of stakeholders: patients, investigators, and trial sponsors/CROs. No single
entity controls all three corners of the trial triangle and connecting the stakeholders is increasingly difficult. But a
growing number of providers are adapting 21st century web-based and mobile tools to connect the corners, boost
trial participation, and speed trial completion.
Multiple Targets, Multiple Approaches
Which tools are most appropriate? It depends on the audience.
“As technology advances, it needs to be utilized to connect with patients,” said Joan Chambers, Chief Operating
Officer of clinical trials information publisher CenterWatch. “Email, Twitter, Facebook, patient communities all have
their place. But you can’t forget that you still have patient populations that are not so tech savvy. You can’t forget the
traditional channels, but they are certainly less useful.”
CenterWatch plays a central role in web-based electronic recruitment even though it does no direct patient
recruitment. The company translates and transforms the wealth of trial recruitment information published at
ClinicalTrials.gov into language that is understandable by nonclinical audiences.
“Our goal is to help CROs, patient recruiters, study centers and study sponsors get as much patient exposure as
possible for their trials,” Chambers said. “There is no sign that patients as a whole are getting more likely to enroll in
trials, but some trials are meeting their enrollment goals on time or even early by connecting more directly with
patients. We are all looking for new models and strategies to provide better trial information to the patient community
to meet sponsor enrollment goals.”
2. Other providers see the opportunity on the investigator side. DrugDev.org matches trial sponsors/CROs with would-be
investigators and adds site management services to strengthen industry links.
“Sponsors always assumed that investigators would be there, but finding qualified investigators who are also
interested is not that simple,” said CEO Ibraheem Mahmood. “We are able to deliver investigators very quickly who
are qualified and enthusiastic about the protocol. That investigator enthusiasm has a significant impact on successful
patient recruitment.”
PrincipalInvestigators.com is another company building a global database of investigators. Would-be investigators
register their clinical background and interests, trial experience, location, and availability; sponsors search the
database for likely matches and post their trial needs.
“We outsource investigator recruitment for CROs,” said Marketing Manager Mike Dziurkawski in Poland. “We offer an
alternative solution for CROs that would rather focus on their own core strengths. We can provide a pool of
investigators that is both deeper and more geographically diverse than any single sponsor or CRO.”
But the more obvious opportunity is linking patients with sponsors. The basic strategy is to target patients who are
most likely to be appropriate for the trial and motivated to participate.
Patient Communities
Some programs target health care providers, usually clinicians and hospitals, by mining electronic health records to
identify specific patient populations. But most would-be recruiters are going directly to patients. Some are CROs
seeking to expand their service offerings by creating or partnering with online patient communities. And others are
patient communities seeking to enhance treatment options by partnering with trial sponsors. Then there are
information brokers seeking to link patient communities with trial sponsors/CROs.
Direct access to patients likely to qualify for trials as well as access to rich population data are key factors in all three
business models. Patient communities self-select for specific conditions, are highly engaged, highly motivated to
share information, and eager to advance treatment.
“The fundamental problem is finding the right patients for your trial,” said Brian Loew, CEO of Inspire, a private
company that links patient support and advocacy groups with trial sponsors. “Online patient communities have given
us an important piece of the puzzle. People in a community are more pre-disposed to participate in a trial than a
random population of patients.”
Bringing patient communities into trial recruitment and retention is hardly new. HIV/AIDS groups broke down the
doors of the clinical trial community in the 1980s and hundreds of disease-specific groups have followed. Breast
cancer, autism, diabetes, asthma—pick a disease and there is almost certainly a patient advocacy group searching
for better medicines, or a cure. Bringing more effective treatments to market faster is in patients’ own best interest.
“We want to see progress in trials and treatments brought to market earlier,” said Diane Gross, MPH, National
Program Director for the Lupus Research Institute (LRI). “Lack of enrollment in trials means slower results. People
with lupus need new treatments now. Anything we can do to move development along is our mission.”
How advocacy groups move development varies dramatically. The Michael J. Fox Foundation leverages its founder’s
star status to build awareness for Parkinson’s as well as channel research funding. The Foundation also launched the
Fox Trial Finder to give patients and caregivers a direct link to Parkinson’s trials that are currently recruiting. LRI and
other advocacy groups use similar tactics, including disease fairs to provide face-to-face information and reach
patients who may not have access to or use web-based technologies.
Jeri Burtchell blogged her multiple sclerosis trial experience and developed Partners in Research, a web-based
community to share MS information and experiences and promote trial participation. An MS trial algorithm on the
home page helps community members decide whether or not they should consider a trial. Except for patients who are
well controlled and tolerate their current medication well, the answer is almost always yes.
CROs on the Move
3. “Patients and trial sponsors need to be brought into the 21st century,” Burtchell said. “Patients stand to gain or lose
the most in research, but the reality is that you trust another patient before you trust an ad on TV or a pitch from
pharma. Patient communities are the trusted resource that can bridge the gap, translate pharma speak into real
language, and bring the patient perspective to trial sponsors.”
CROs are seeing similar value in bringing patients, and the patient perspective, to their trial sponsor clients.
“Patients are the most underutilized resource in the entire healthcare system because the traditional channels used to
interact with them were created before the digital era,” said John Reese, Senior Director, Health Engagement and
Communication, for Quintiles. “In the United States, 90% of patients never hear about a clinical trial in their lifetime.
We are trying to reach those 90%, using digital channels to educate and energize patients who are already
empowered to improve their health through social media, patient communities and information sharing.”
Quintiles created patient communities based on medication safety resources (MediGuard.org) and trial resources for
specific diseases (ClinicalResearch.com). Patients and caregivers received qualified medical information and
updates, Quintiles and its clients get de-identified patient data for population studies, and personal information that
can be used to target trial participation offers. Reese said a recent COPD study enrolled its first patient in six minutes
and completed enrollment in six weeks.
Other CROs are using social media and data mining to identify and contact potential trial participants. In 2013, PPD
acquired Acurian, an electronic patient recruitment and retention firm, to help meet recruitment goals for its clients’
trials and support their strategies for data-driven feasibility, site selection and enrollment delivery. Acurian can tap a
database of more than 70 million households that includes self-reported disease information and medical data and
reach out to patients directly via email, social media and other online techniques.
“We still do some radio and TV recruitment, but it is seen as less cost-efficient,” said Rick Malcom, Executive Vice
President and General Manager of Acurian. “Web-based activities have become increasingly important for patient
recruitment and retention. But there is no one technique that is going to resolve every recruitment and enrollment
challenge. Many people are potentially interested in trials. But it is very hard to make people aware that a trial is
happening five miles away without specialized help.”
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