Participant Level Data from
Clinical Trials used for Licensure
Should be made Publicly
Available to Anyone
Group 2
Abhirup Datta, Michelle Gleason, Emily Goren, Reilly Hourigan,
Eleena Iisakka, Ahmad Raza, Youssef Roman, Robert Stewart
Professional Perspective
Fulfills obligations to research participants
EFPIA and PhRMA--biopharmaceutical companies in Europe and America
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endorsed joint “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to
Patients and Researchers.” July, 2013.
“The data sharing commitments reflect...companies’ strong support for sharing clinical trial data
to benefit patients and foster scientific discovery in a way that maintains patient privacy, the
integrity of regulatory systems, and incentives to invest in biomedical research.”
(Richard Bergström, Director General of EFPIA)
IOM (Institute of Medicine). 2013. Sharing clinical research data: Workshop summary. Washington, DC: The National Academies Press.
EFPIA and PhRMA Release Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients. 2013.
Patient Perspective
De-identified to maintain privacy
• Main concern of data sharing
Patient can make educated decisions
• Ability to weigh pros and cons
Develop trust with clinician and the process
• Comfort
Enhance patient care
• Develops confidence
Clinician Perspective
Patient trust is vital to the patient–physician relationship
•
•
Patient trust in clinician provides basis for sharing personal information
necessary for the clinician to provide the best care
Patients' trust in their physician are strongly associated with healthcare
adherence and patients' satisfaction with their physician (Safran, 1998)
•
“Extensive research has shown that no matter how knowledgeable a
clinician might be, if he or she is not able to open good
communication with the patient, he or she may be of no help.”
(Asnani, 2009)
Safran DG, Taira D, Rogers WH, Kosinski M, Ware JE, Tarlov AR. Linking primary care performance to outcomes of care. Journal of Family
Practice. 1998; 47(3):213-220.
Asnani MR. Patient-physician communication. West Indian Med J. 2009; 58(4):357-61.
Clinician Perspective
Strengthens evidence-based medicine
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•
•
Clinician can trust results of clinical trials used to license the drugs they are
prescribing
Evidence-based medicine must take into account all evidence on risk and
benefits of available treatments, but current published data and reports on
clincaltrials.gov are only a fraction of the evidence
“In a profession that seeks to rely on evidence, it is ironic that we tolerate a
system that enables evidence to be outside of public view.” (Krumholz,
2012)
Cabana MD, Rand CS, Powe NR, et al. Why Don't Physicians Follow Clinical Practice Guidelines?: A Framework for Improvement. JAMA.
1999; 282(15):1458-1465.
Krumholz HM. Circulation: Cardiovascular Quality and Outcomes. 2012; 5:141-142.
Research Perspective
Secondary data analysis
•
Test additional hypotheses
Education, Training, and Future Research
•
Provides opportunities for young researchers to use real-world data
Keeping them honest
•
Aligns with the general principles of peer-review
•
Opportunity to apply an objective perspective and find something the
research might have missed
•
Can also have dramatic ramifications, see for example Reinhart and
Rogoff (2010)
Public Health Perspective
Transparency and Credibility
•
Peer review
•
Publication bias
Other benefits
•
Better trial designs
•
Increased reputation risk
Yale University Open Data Access (YODA) Project
•
“Provides a means for rigorous and objective evaluation of clinical trial data”
•
Currently enrolled organizations: Medtronic, Johnson & Johnson
Hans-Georg Eichler, M.D., Frank Pétavy, M.Sc., Francesco Pignatti, M.D., and Guido Rasi, M.D. N Engl J Med 2013; 369:1577-1579
Pros vs. Cons
Patient privacy
Pharma proprietary interest
Patient trust
Clinician confidence
Secondary data uses
Improve trial designs
Accountability
Public health interest
Open access of corporate clinical
trial data to the general public is not
a good idea.
GROUP3:
Patrick Kurkiewicz, Brent Leininger,
Lifeng Lin, Xiang Li, Bryan Trottier Jr,
Yuanyuan Wang
Federally funded research should have open
access.
Not corporate research
In theory, open access is a great
idea.
• Makes innovation more efficient
•
•
•
•
Less overlapping trials
Increased power from meta-analyses
Better understanding of prognostic factors for
design of future trials
Companies work together and learn from one
another and everyone wins
• Public Good
•
Less participants exposed to risks in trials for
But in practice, open access would
disincentivize innovation
Proprietary Info.
• Innovation starts with
proprietary information/
intellectual property
• In many cases proprietary
information comes from a trial
that company has
managed.
Operating
Costs
Proprietary drugs.
Profit “Retained Earnings”
Competitors Would take
Advantage of Free Information
“Requests for clinical study to the EMA have
been filed mostly by competitors of the
company who performed the initial study”. 47.
Rabesandratana T. Europe: drug watchdog ponders how to open clinical trial data
vault. Science 2013;339:1369-70.
Competitor
Investor
Media Sensationalizes
-Will play up potential issues with current
procedures and devices to gain viewers,
listeners, and readers.
The USA is the Most
Litigious Society in the
World.
-We spend about 2.2 percent of gross
domestic product, roughly $310 billion a year,
or about $1,000 for each person in the
country on TORT litigation, much higher than
any other country. (A large part of the cost of
healthcare)
-How do less scientifically juries and judges
Who pays for open access?
-The company the acquired the data?
-Current system already has an issue with
cost, not quality (relatively speaking).
-The government?
-Why not just expand FDA to take on more
monitoring responsibility?
In terms of spotting issues for the
public good…Is Secondary Review
More Legitimate?
EVERYONE has some potential for conflict of
interest
-Academia
-Competitors
-The Media
-The FDA
Our Current System
-But Manufacturers’ interest in profitability
goes two ways
-Interest in limiting liability and public opinion
causes them to share much of their data.
-Rule of law/TORTs
-Research necessary for the public good is
paid for by government.
-We have an approval process via the FDA
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Participant Level Data from Clinical Trials used for Licensure Should