Featured Research

from universities, journals, and other organizations

Expanding access to clinical trial data responsibly

Date:
October 21, 2013
Source:
Harvard School of Public Health
Summary:
A new report proposes recommendations for how to expand public access to data from clinical trials while protecting patients' privacy and weighing pharmaceutical companies' business interests. Recently, the European Medicines Agency announced it will provide public access to participant-level data submitted in applications for marketing approval in Europe, prompting questions about whether the US FDA should follow suit.

A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients' privacy and weighing pharmaceutical companies' business interests. Recently, the European Medicines Agency (EMA) announced it will provide public access to participant-level data submitted in applications for marketing approval in Europe, prompting questions about whether the U.S. Food and Drug Administration should follow suit. Data releases by the EMA have spurred litigation by drug companies and heated debate about whether clinical trial data should be protected as proprietary information or widely shared.

Related Articles


The report, published online October 21, 2013 in The New England Journal of Medicine, was released to coincide with the first meeting of the Institute of Medicine's Committee on Strategies for Responsible Sharing of Clinical Trial Data on October 23. The Institute of Medicine convened the committee on an accelerated timetable to develop a framework for expanded public access to clinical trial data. An initial report is expected in January 2014.

"Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data," said Michelle Mello, professor of law and public health at the Harvard School of Public Health and lead author of the report. "The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants' privacy, avoiding 'junk science,' and minimizing burdens on trial sponsors?"

According to the authors, expanding access to participant-level data could both serve as a check on trial sponsors' characterizations of a product's safety and effectiveness, as well as open up new avenues of scientific inquiry beyond the scope of the original study. However, there are concerns that research participants' identities could be discovered, and that competitors and others could use the data to produce flawed analyses. The FDA historically has treated participant-level clinical trial data submitted to the agency as confidential.

The authors recommend that a system of expanded access to clinical trial data apply to trials of all approved prescription drugs, medical devices, and biologics; and treat all trial sponsors and qualified data requesters evenhandedly. It should have mechanisms to ensure that all sponsors and data users adhere to minimum standards -- for example, rules should specify what must be shared, and data users should commit to following a scientifically sound analytical plan. If sponsors are permitted to influence which data requests get granted, they should be required to apply explicit decision criteria and publicly explain the reasons for denials. Using an independent intermediary organization to make those decisions, however, may be preferable.

"As in other areas of health care, the push for greater transparency in the area of clinical-trial data appears inexorable," the authors wrote. "The question is not whether, but how, these data should be broadly shared. The potential risks to research participants and trial sponsors must be thoughtfully addressed in the design of any new data-sharing system but need not block progress toward achieving the promise of 'big data' in the clinical trials context."

"The European Medicines Agency has hastened to impose regulatory mandates for data sharing, which may indeed be needed," said Mark Barnes, a partner at Ropes & Gray LLP and the Harvard faculty co-director of MRCT, "but such mandates need to be carefully considered, to avoid harms to participants and to preserve commercial incentives for industry to invest in vital research."


Story Source:

The above story is based on materials provided by Harvard School of Public Health. Note: Materials may be edited for content and length.


Journal Reference:

  1. Michelle M. Mello, Jeffrey K. Francer, Marc Wilenzick, Patricia Teden, Barbara E. Bierer, Mark Barnes. Preparing for Responsible Sharing of Clinical Trial Data. New England Journal of Medicine, 2013; 131021140136002 DOI: 10.1056/NEJMhle1309073

Cite This Page:

Harvard School of Public Health. "Expanding access to clinical trial data responsibly." ScienceDaily. ScienceDaily, 21 October 2013. <www.sciencedaily.com/releases/2013/10/131021211716.htm>.
Harvard School of Public Health. (2013, October 21). Expanding access to clinical trial data responsibly. ScienceDaily. Retrieved October 25, 2014 from www.sciencedaily.com/releases/2013/10/131021211716.htm
Harvard School of Public Health. "Expanding access to clinical trial data responsibly." ScienceDaily. www.sciencedaily.com/releases/2013/10/131021211716.htm (accessed October 25, 2014).

Share This



More Science & Society News

Saturday, October 25, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Protective Suits Being Made in China

Ebola Protective Suits Being Made in China

AFP (Oct. 24, 2014) A factory in China is busy making Ebola protective suits for healthcare workers and others fighting the spread of the virus. Duration: 00:38 Video provided by AFP
Powered by NewsLook.com
WHO: Millions of Ebola Vaccine Doses by 2015

WHO: Millions of Ebola Vaccine Doses by 2015

AP (Oct. 24, 2014) The World Health Organization said on Friday that millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines would start being tested in March. (Oct. 24) Video provided by AP
Powered by NewsLook.com
Microsoft Riding High On Strong Surface, Cloud Performance

Microsoft Riding High On Strong Surface, Cloud Performance

Newsy (Oct. 24, 2014) Microsoft's Q3 earnings showed its tablets and cloud services are really hitting their stride. Video provided by Newsy
Powered by NewsLook.com
EU Gets Climate Deal, UK PM Gets Knock

EU Gets Climate Deal, UK PM Gets Knock

Reuters - Business Video Online (Oct. 24, 2014) EU leaders achieve a show of unity by striking a compromise deal on carbon emissions. But David Cameron's bid to push back EU budget contributions gets a slap in the face as the European Commission demands an extra 2bn euros. David Pollard reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Science & Society

Business & Industry

Education & Learning

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins