The document proposes a novel structure called a Patient-Centered Research Management Group (PCRMG) that would specialize in comparative effectiveness research. Key aspects are that it would incorporate significant patient input into study design and would facilitate collaboration between healthcare systems, pharmaceutical companies, patients, and other stakeholders. The goal is for research to better represent real-world clinical practice and patient preferences. Some benefits mentioned include exploring off-label drug uses, targeting medicines based on patient profiles, increased data sharing, and lower study costs. Pharmaceutical company involvement is argued to help develop personalized medicine and target drug development based on patient priorities.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
Patients Recruitment Forecast in Clinical TrialsCognizant
Inaccurate patient recruitment forecasts for clinical trials cost pharmaceuticals and medical device manufacturers a huge amount of resources each year. We offer descriptions and examples of applying stochastic and non-stochastic approaches to increase accuracy in this crucial stage of drug testing.
Best strategies for successful recruitment and retentionTrialJoin
Best strategies for successful recruitment and retention for clinical research studies
Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
Patients Recruitment Forecast in Clinical TrialsCognizant
Inaccurate patient recruitment forecasts for clinical trials cost pharmaceuticals and medical device manufacturers a huge amount of resources each year. We offer descriptions and examples of applying stochastic and non-stochastic approaches to increase accuracy in this crucial stage of drug testing.
Best strategies for successful recruitment and retentionTrialJoin
Best strategies for successful recruitment and retention for clinical research studies
Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
A presentation showcasing some of the patient recruitment challenges that I encountered as a recruitment manager as well as some of the strategies -- DIGITAL ADVERTISING -- I used to overcome them.
•The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings.
•Randomized clinical trials are deemed as a gold standard method for analyzing and evaluating the safety and effectiveness of medical devices or pharmaceutical drugs.
•The most challenging part of conducting a randomized clinical trial are related to handling ethical and regulatory systems.
To Continue Reading : https://bit.ly/3eypDDm
Contact Us:
Website : https://bit.ly/3fQY0p0
Email Id: sales.cro@pepgra.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
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
Health outcomes research is seen as a cost-effective investment in measuring and defining value of new innovations in health care. We provide an overview of field and its applications
The Role of Real-World Data in Clinical DevelopmentCovance
Healthcare is experiencing an avalanche of electronic data with sources that include social media, smart phones, activity trackers, electronic health records (EHRs), insurance claim databases, patient registries, health surveys, and more. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Improving Inclusion/Exclusion Criteria for Clinical TrialsBrook White, PMP
Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. This presentation provides suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.
A presentation showcasing some of the patient recruitment challenges that I encountered as a recruitment manager as well as some of the strategies -- DIGITAL ADVERTISING -- I used to overcome them.
•The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings.
•Randomized clinical trials are deemed as a gold standard method for analyzing and evaluating the safety and effectiveness of medical devices or pharmaceutical drugs.
•The most challenging part of conducting a randomized clinical trial are related to handling ethical and regulatory systems.
To Continue Reading : https://bit.ly/3eypDDm
Contact Us:
Website : https://bit.ly/3fQY0p0
Email Id: sales.cro@pepgra.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
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
Health outcomes research is seen as a cost-effective investment in measuring and defining value of new innovations in health care. We provide an overview of field and its applications
The Role of Real-World Data in Clinical DevelopmentCovance
Healthcare is experiencing an avalanche of electronic data with sources that include social media, smart phones, activity trackers, electronic health records (EHRs), insurance claim databases, patient registries, health surveys, and more. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Improving Inclusion/Exclusion Criteria for Clinical TrialsBrook White, PMP
Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. This presentation provides suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.
A Pharmaceutical Industry's Role in Clinical Trial Improvement.pdfSollers College
The drive to quickly develop a vaccine in record time should concentrate attention on common bottlenecks in the clinical trial process, as well as steps that the life sciences industry could take to reduce those bottlenecks and speed up the process for other drug candidates.
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.
Patient Reported Outcomes (PRO) - Challenge and potential solutions.
Why and how can medical device and pharmaceutical companies, as well as the entire healthcare sector, leverage patient engagement with next-generation ePRO solutions?
Discover our white paper...
Traditionally, physicians recruited clinical trial subjects, but pharmaceutical companies have become ever more involved through centralized campaigns. Physicians are vital to a trial and the pharmaceutical effort helps shift some of the recruitment demands away from the site to allow them to focus on the subjects. Thus, it is practical to understand if different recruitment methods could change or skew the study population. This study determines if differences or similarities occurred between subjects recruited by physicians and pharmaceutical companies. It discovered that some of both occurred. The pharmaceutical company efforts helped recruit potential subjects from the general population that were similar to subjects recruited by the physicians, but this particular campaign was limited by language which affected recruitment of Hispanic subjects. The social impact of this study provides insight about pharmaceutical company recruitment. Since the National Library of Medicine has indicated that clinical trials should reflect the broader diseased population, the efforts of the pharmaceutical company can help support the physicians’ efforts by recruiting from the broader population. Together, both efforts can create a global good by allowing the trial to reflect the population of post-approval use. These findings still raise a question about the proper balance between the two recruitment groups so that the intended characteristics of the diseased population are maintained. Because differences between physician and pharmaceutical recruited subjects can exist, the potential of one group to bias the trial results exist. As such, some analysis by recruitment method can help ensure that variations in the study population are minimal without skewing the data to create positive study results.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
IPTV Subscription UK: Your Guide to Choosing the Best ServiceDragon Dream Bar
"IPTV Subscription UK" (Internet Protocol Television) has revolutionized the way people watch TV, offering a vast array of channels and on-demand content delivered over the internet. If you’re considering an IPTV subscription in the UK, here’s a comprehensive guide to help you choose the best service for your needs.
Using Generative AI for Content MarketingChuck Aikens
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Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
Lars Winkelbauer — Sustainable Development in the Era of Air Cargo Technologylarswinkelbauer23
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“Private Security Guards Service” provide a crucial layer of protection for individuals, businesses, and events, ensuring safety and peace of mind in various settings. Here's an overview of what private security guard services entail and how they can benefit you.
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Matt Conway - Attorney - A Knowledgeable Professional - Kentucky.pdfMatt Conway - Attorney
After completing his law degree at the Brandeis School of Law at the University of Louisville, Matt Conway (Attorney) embarked on a varied career that has included roles in real estate law, public prosecution, and private practice. Find out more about him at his official site https://mattconway.net/
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HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
What are the main advantages of using HR recruiter services.pdf
Pcori final writeup
1. Hillel Bocian, MD/MBA
Danny Nguyen, Pharm.D/MBA
Patient-Centered Research Management Group
Background: The Current State of Clinical Trials and Comparative Effectiveness
Research
Current health systems do not have the capacity or infrastructure to sustainably support
clinical trials. Additionally, the number of clinical trial investigators is decreasing, and
young physicians are not become clinical investigators at a sufficient rate. The ones
that do participate usually do so only once. This owes to misaligned financial
incentives, as well as to frustrating barriers in the implementation of clinical research
(from IRB approval). A large percentage of clinical trial studies are not completed, often
because of an inability to recruit sufficient patients (i.e. 40% of National Cancer Institute
trials that reach Phase III fail for this reason). There is low awareness among patients
with chronic conditions of the existence of clinical trials. When patients are made aware
of clinical trials, their skepticism and lack of understanding of the process disincentivizes
their participation (despite the fact that most patients who participate in clinical trials
report positive experiences). Furthermore, most community doctors are not aware of
ongoing clinical trials, and do not know how to plug their patients into this system.
A large impediment to the regular conducting of clinical trials within the healthcare
delivery system is the lack of an infrastructure for sequential and simultaneous clinical
trials in these hospitals. The current, grant-funded research model has been described
as a “cottage industry,” because there is no sustainable, replicable infrastructure for
clinical trials (protocol development, recruiting of patients, recruiting of faculty, IRB
approval, and so forth). However, with the proper financial incentives and corporate
supervision, we submit that this is a fixable problem.
Even when studies are adequately powered, poor study design and an inefficient
system for disseminating information render the studies useless in terms of effecting
change in clinical practice. In other words, systems for translating the research into
evidence-based practice are lacking. Industry, government, patients, and physicians
are silo’d from each other. As such, there are tremendous inefficiencies in the
information infrastructure, in the drug development process, in the refinement of clinical
processes,
Research-and-development process of pharmaceuticals is not patient-centered. This
has led to a number of consequences. It is a wide consensus that investigator-initiated
research has failed in regards to generating comparative effectiveness studies. The
growth of patient advocacy groups, the institution of PCORI, demand for increased
transparency of costs, the impending expansion of insurance coverage and range of
plan options, and so forth, all have increased the role of patient decision-making.
2. Initiatives such as PCORI were largely created because medical research was taking
too long to become translated into widespread practice, or studies that had been
translated into practice ended up rendering guidelines that were not beneficial to certain
sub-groups of patients. This is largely because the studies weren't well-designed, as
they did not properly represent the range of comorbidities, ages, or socio-demographic
factors.
Clinical trial research does not sufficiently incorporate the diversity of the patient
population. Specifically, differences in how patients with dissimilar socioeconomic
backgrounds, genetic profiles, environmental influences, co-morbidities, medication
lists, and personalities are not well-reflected in clinical trials. Clinical trials fit a specific
mold of study: randomized, highly-controlled studies on patients with few or no co-
morbidities. This presents several problems. First of all, the efficacy and side effect
profile of a drug in one patient will be different from that in another patient for purely
pharmacogenetic reasons. For instance, the side effect profiles of Avandia and Vioxx
were not well-understood until they were overprescribed for patients. Neither hormone-
replacement therapy for women with heart disease and autologous bone marrow
transplantation were demonstrated to have clinical utility above less-risky alternatives,
and often came at the expense of adverse outcomes and poorly-controlled costs.
Second, patients have different priorities and intentions with regards to their medical
care. These study design of clinical trials are frequently flawed with respect to
comparison groups, the study time frame, patient selection, and selection of surrogate
markers/endpoints. In summary, current clinical trials practices are not adequate for
determining treatment regimens for complex and diverse patient populations, and are
not conduits for the implementation of personalized medicine. Very few phase III trials
for chronic conditions include patient-centered outcome measurement. The artificial
conditions under which they are conducted do not reflect actual clinical practices.
These concerns have spurred innovation of systemic structures that will enable
comparative effectiveness research to take place reliably and with meaningful
applications.
The era of patient-centered medical care has arrived. Patients must be engaged in the
orientation of the research, the research process itself (identification of outcomes and
selection of comparators), and how the research findings are used to inform clinical
practice. Specifically, they should be involved in framing the research questions, the
usability criteria (the thresholds at which research findings will alter clinical decision-
making), and in the subsequent changes that are made to clinical practice. Few
We argue that comparative effectiveness research is necessary not only for currently-
existing drugs and regimens, but also for development of new drugs and regimens.
Collaboration of the pharmaceutical industry with the care delivery system will allow for
patients and patient advocates to be involved in the decisions of which drugs to build
and how they should be targeted towards patient sub-populations.
3. Patient criteria may involve lifestyle factors that involve their social lives, romantic lives,
professional lives, and their overall happiness. Patient prioritization of outcomes (i.e.
objective measures vs. lifestyle impacts) will help evaluate the drug from multiple
angles. This will benefit both patients and pharmaceutical companies: patients will be
able to select drugs based on the benefits important to them, and pharmaceutical
companies will still be able to market drugs that were less selective based on, say,
biomarkers, but more effective with respect to patient identifiers. Patient-determined risk
factors, which may not have occurred to researchers in isolation, may prove to be better
proxies of the effectiveness of a medication regimen. For instance, in determining
quality-of-life in the context of heart failure, a medication regimen can be determined
largely by asking the patient about being out-of-breath after a certain number of blocks
(rather than merely examining ejection fraction or BNP levels).
Comparative effectiveness research has failed for a number of reasons: misaligned
financial incentives, equivocality and ambiguity of study results, and limited clinical utility
(from the perspective of both the providers and the patients)
FDA restrictions on comparative effectiveness research initiatives by the pharmaceutical
companies. Part of what is impairing the dissemination of comparative effectiveness
research is that the current way that clinical trials are being performed by the drug
companies cannot be taken to constitute “substantial clinical experience,” because a
randomized clinical trial (rather than an observational study, for instance) does not truly
reflect clinical practice. Manufacturers must tread carefully when speaking about
emerging benefits with providers, and the potential legal repercussions (resulting from
the FDA’s narrowly-defined language) disincentivize pharmaceutical company initiation
of or participation in comparative effectiveness research efforts.
Overall Description of Idea
We propose a novel structure called a Patient-Centered Research Management Group
(PCRMG). The PCRMG is a hybrid between a healthcare delivery system, a Contract
Research Organization (CRO) and a Site Management Organization (SMO) that will
specialize in comparative effectiveness research. Key to the design of this special
entity will be its emphasis on incorporating patient input and involvement in the study
design. The hospital and its providers will act as the “matching system” that links the
patients with the researchers (who are, in this case, the pharmaceutical company).
Each stakeholder in the structure will provide numerous advantages in the realms of
cost control and clinical utility. Most importantly, the structure will provide a streamlined
system for conducting studies that are truly representative of clinical practice (rather
than being highly selected trials), as these studies would have broad selection criteria
from the patient population and would take into account patient preferences
The PCRMG adapts the concept presented by Janet Woodcock for a “national clinical
research infrastructure,” but enables the structure to conduct comparative effectiveness
research with high patient involvement, and to do this via a collaborative initiative with
4. pharmaceutical companies. Our structure is designed to increase patient involvement
in drug development and in treatment protocols, allowing patients to influence drug
development, the contexts in which the drug is prescribed, and how the drug is
combined with other treatments. The PCRMG would take on some CRO duties, such as
clinical trial study design and management. It would also conduct the later “front-end”
stages of the clinical trials that are performed by SMO’s (recruiting patients, training
investigators, tabulating data, and so forth). Essentially, the pharmaceutical company
would be moving downward in the value chain, i.e. vertically-integrating with the care
delivery system.
In our design a pharmaceutical company will contract with a healthcare system (for
instance, an inpatient hospital, or a non-profit outpatient clinic in an HMO) to fund and
design comparative effectiveness research trials. Importantly, patient input will be
incorporated at all levels of study design. Patients, patient advocates, providers,
payers, and the pharmaceutical company will collaborate in roundtable settings, with an
external moderator, to develop the following for each study.
We propose that patients would be involved in:
-preliminary stages of drug development
-evaluation of medication regimens
-study and expansion of off-label uses
-movement towards personalized medicine
Note that this WOULD NOT REPLACE standard clinical trials to test the safety of the
medication in animals and in highly-controlled human trials. However, the structure
would add value in: 1) phase IV/V (monitoring long-term effects) 2) extending the clinical
trial into further phases that test it in specific subpopulations, with other medications,
with comorbidities, with different patient preferences and 3) guiding drug development
before phase I even takes place.
This structure would provide advantages in the following areas:
-Exploration of off-label usage of medications
-Targeting of medicines based on a patient’s unique genomic profile, unique
Preferences, patient preferences
-Information sharing between healthcare networks via registries. The
pharmaceutical company would provide the crucial link for registries, data
transmissibility (i.e. standardized data
5. -defrayed cost of clinical trial implementation => speedier drug development
-Increased transparency of drug price-setting, formulary determination, and
reimbursements
Care centers will be able to use the collaborative data infrastructure to access data from
and collaborate with other care centers. Multi-center data will be aggregated through
registries. Academic health centers that participate will benefit from regulatory freedom
emerging from a centralized IRB process, allowing for swifter and more cost-effective
implementation of translational research. The patient will benefit in several ways:
access to novel treatments, highly-personalized treatments, lower out-of-pocket-costs,
and an empowered voice in the treatment process.
Another unique element would be the funding and financing mechanism of
medications in the PCRMG. The assessment of which drugs to place on the formulary,
and where on the formulary they should be placed, would be much more closely-
correlated to their respective clinical utilities (and the ease with which that clinical utility
could be measured) under our system. .
*Coverage with evidence development, and other “conditional covering”
mechanisms
*Risk-sharing agreements (for example, the pharmaceutical company would give
a rebate to the hospital for improved outcomes in patients that are compliant with
the drug regimen, or pharmaceutical companies subsidize the treatment of
adverse events that their medications were supposed to prevent). Not only do the
pharmaceutical companies benefit from risk-sharing, but the patients and
physicians benefit too because there are incentives for encouraging patient
compliance with medication.
The Case for Pharmaceutical Company
Involvement
The life sciences industry is considered a “stakeholder” in PCORI. The Pharmaceutical
Research and Manufacturers of America (PhRMA) has come out in support of
comparative effectiveness research, citing the increased transparency and clinical utility
that will result. In fact, pharmaceutical executives have portended that CER will be the
differentiating factor between companies that succeed and companies that do not.
However, the literature we surveyed, for the most part, does not emphasize the
pharmaceutical company as an important stakeholder, and does not venture to describe
potential roles that the pharmaceutical companies could have in patient-centered
medical care. Mention of pharmaceutical companies is likely to trigger knee-jerk
reactions that frame the company as a biased source that does not have the patient’s
best interests in mind. They are, as such, excluded de facto from the possibility of
6. involvement in patient-centered comparative effectiveness research, and seem to be
relegated to the role of the entity that manufactures and ships the drugs that will
ultimately be evaluated in comparative effectiveness trials. On a broad level, it is almost
unconscionable to think that the pharmaceutical company, which makes decisions on
what drugs to manufacture, funds and houses research-and-development, determines
drug safety, and sets prices would not be included in a patient-centered model.
Our model allows the industry to act as both a manufacturer and a service organization.
The core competencies of private sector drug and device manufacturers can be
harnessed to benefit patients in innovative manners. Among these core competencies
is marketing to patients, an ability that will be key to patient recruitment and patient
engagement in the planning and design of studies.
Development of a comparative effectiveness structure that incorporates the
pharmaceutical industry will allow for the development of personalized medicine. For
instance, patient input on research will spur drug companies to assess the clinical utility
of their medications based on market segment factors: elderly patients may prioritize
factors such as mobility, while younger patients may prioritize factors such as sexual
functioning and work performance. These efforts will permit superior risk-stratification of
patients, with corresponding targeting efforts driven by the pharmaceutical company
that allow patients to achieve optimal life-quality and achieve their personal outcome
criteria. These efforts will manifest as the pharmaceutical company positioning its
products.
The criteria and methodology being developed for comparative effectiveness research
should also be used in much earlier stages: i.e. they should not just be to investigate
drugs that have already undergone clinical trials, but should also be used prospectively
in development of novel treatments or care bundles. If patients are included from the
beginning in the study design, the credibility and viability of the results will be even
stronger.
Key steps
*Targeting underserved populations:
In order to optimally represent underserved populations, it would be best to pilot this
system in an academic medical setting. First, academic medical settings are most likely
to serve patients who have several medical and mental co-morbidities, polypharmacy,
low income, and low literacy. Second, academic medical centers are highly likely to be
staffed by providers who are aware of the comparative effectiveness research that has
been done and that needs to be done.
7. *Study and trial designs:
-Emphasis on observational studies and prospective trial designs
-Emphasis on personalization of data-seeking and, correspondingly,
personalization of treatment regimen
-Naturalistic and pragmatic “simple” trials that can efficiently test out a new
treatment in the context of a typical clinical practice
-Adaptive trials (where the variable and control groups, as well as the treatment,
can change in the middle of the trial)
-Cumulative Meta-analysis, made possible by registries.
-Standardized research data sets, with subsequent cumulative meta-analyses
*Patient Portal
-Engage patients, through cost incentives, to tabulate their side effects and mark
how they feel on a wellness scale on an online database.
-Marketing surveys for the purpose of segmenting patients
*Patient registries:
-Implement patient-generated data elements => standardize across PCMRG’s.
- use billing codes for bundled payments (CPT, DRG) and RAF score in order to
track patients and correlate with co-morbidities and patient-generated data
elements.
*Overcoming FDA barriers:
Our system would be possible if the manufacturer was willing to take the risk of abiding
by the looser Section 114 standard, rather than the more-confining FDA standard of
communication. In a more ideal scenario, PCORI would influence the FDA to adjust its
language in order to accommodate comparative effectiveness research. There is a
crucial asymmetry: payers are allowed to make reimbursement decisions with much
looser standards (with respect to the type of research they are relying on) than
pharmaceutical companies are allowed to use in their communications with physicians.
These payers are not accountable to use “competent and reliable” evidence, as Section
114 states.
8. PCORI should lobby the FDA to loosen its regulation of how the manufacturer can
communicate with the provider. The “competent and reliable” evidence standard should
be adopted in favor of the “substantial evidence” standard. Currently, “substantial
evidence” is limited to two randomized clinical trials and/or information in FDA-approved
labeling. This does not confer sufficient real-world benefits, as these pieces of
information do not reflect the “real world.” Congress has attempted to loosen the
standard to “competent and reliable” evidence, under Section 114 of the FDA
Modernization Act of 1997, in order to broaden the evidence that manufacturers can
communicate to providers as including “tests, analysis, research, studies or other
evidence based on the expertise of professionals in the relevant area…conducted and
evaluated in an objective manner by persons qualified to do so, using procedures
generally accepted by others in the profession to yield accurate and reliable results.”
*Patient buy-in:
It must be communicated how participation in design of the comparative
effectiveness research, as well as actual participation as a subject in the study,
will help them and patients like them. This will require the use of expert
facilitators
9. Sources
Berger, Mark L. “Comparative Effectiveness Research: The View from a Pharmaceutical
Company.” Global Health Outcomes, 2012.
Monroe, C. Doublas, “Kaiser Permanente’s Evaluation and Management of Biotech
Drugs: Assessing, Measuring, and Affecting Use.” Health Affairs, 2006.
Pearson, Steven D. “How Medicare Could use Comparative Effectiveness Research in
Deciding on New Coverage and Reimbursement.” Health Affairs, 2010.
Selker, Harry P. “Industry Influence on Comparative-Effectiveness Research Funded
Through Health Care Reform.” New England Journal of Medicine, 2009.
Witty, Andrew, “New Strategies For Innovation in Global Health: A Pharmaceutical
Industry Perspective.” Health Affairs, 2011.