EU Will Require More Clinical Trial Transparency — Will U.S. Be Next?
Sponsors have to give simple-language study results
By Melinda Young, Editor
The EU soon will require investigators to give people the kind of transparent, easy-to-access clinical trials information they’ve been conditioned to expect in the age of Google.
In 2017, researchers and clinical trial sponsors with sites in the EU will need to create lay summaries of study results and make these available to research participants. The EU’s move to increase transparency is following a trend that the human research protection industry also is noticing in North America.
Returning general clinical trial results, which is different from giving individuals their personal clinical trial information, is a growing trend that’s reaching a tipping point, says Ken Getz, MBA, associate professor and director of the Center for the Study of Drug Development at Tufts University in Boston. Getz also is the founder and board chair of the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP).
Companies increasingly are considering piloting a trial results disclosure initiative, partly in response to the patient centricity movement, Getz says. (For more information on how and why to return results, see related story in this issue.)
“There’s this growing recognition that returning trial results is the ultimate act of appreciation, and it’s also sort of integral to ensuring that our study volunteers are engaged as partners in this research process,” Getz adds.
The U.S. Department of Health & Human Services (HHS) Secretary’s Advisory Council on Human Research Protections (SACHRP) addressed the issue of sharing general study data and results with subjects first in 2013 and, also, in later commentary.1
SACHRP said federal agencies should take steps to promote the return of general results to subjects, starting with the FDA, which needs to provide clear guidance on how clinical investigators and sponsors can avoid promotion of medical products when providing general results to subjects. Also, there needs to be agency guidance on whether an IRB needs to review the communications of research results to subjects, according to SACHRP.1
“The European Union is pioneering the evolution of trial results summaries into plain language, and we see that as an incredible new development,” Getz says.
The European Parliament in May 2014 published the European Clinical Trial Regulation (EU No. 536/2014) that explains new requirements for authorizing, conducting, reporting, and providing transparency in all clinical trials that have at least one EU member site.2
Sponsors and investigators have to disclose results in a way that the average person can understand, including comments on the outcome of the trial.2 (For more details on the EU requirement, see related story in this issue.)
In 2008, the United States required a return of generalized clinical trial results eight years after the NIH launched the database ClinicalTrials.gov. U.S. sponsors were required to post their studies’ summary results on the website. But sponsors were not mandated to write the results in language that non-scientists/doctors would understand, as the EU has stipulated.
“The tipping point is that the European Union has passed regulations requiring the return of a layperson-understandable trial result,” says James Riddle, MCSE, CIP, CPIA, vice president of client services at Kinetiq, a division of Quorum Review IRB in Seattle.
“It’s time to ask, ‘Should the United States follow the EU and finally get understandable results back to subjects, whether the results are good or bad?’” Riddle says.
The clinical trial enterprise has not done a good job of communicating the importance of participants’ contribution, he says.
“There’s growing evidence that the clinical trial community should and needs to develop a way to get information back to participants to facilitate clinical research and gain their trust,” Riddle says.
Returning aggregate results to people who volunteer for research is something that is becoming increasingly important, says Mitchell Parrish, JD, RAC, CIP, vice president of legal affairs for Kinetiq.
“Nationally, it’s in line with dissemination of information as we see through the internet and social media,” Parrish says. “People have more access to information, and in our field there’s a natural push because researchers can benefit by keeping participants involved and engaged.”
But it’s also complicated. Parrish notes that returning generalizable results raises the following questions:
- What information is meaningful enough to disseminate?
- What are the actual data that should be presented?
- What is the best method for providing data in a way that is understandable to a layperson?
- Should data be presented in graphic form, or in an interactive PowerPoint?
“We’ll always need a written explanation, but we need to keep it short, concise, understandable, and couple it with graphics,” Parrish says. “Graphics help people connect and understand results.”
IRBs are well-positioned to help answer these questions because of their experience with shaping consent forms and making those easier to understand from study volunteers’ perspective, Parrish adds. “Now, it’s a natural progression for IRBs to collaborate with sponsors and researchers to come up with the best way to send information back to participants in a way that is understandable.”
Also, there eventually might be a debate on whether these layperson summaries will require IRB review, he says.
“It might be up to the sponsor or researcher to make a judgment call and ask if they need feedback from someone who has experience in this field,” Parrish says.
The EU regulation addresses informed consent, clarifying the use of data obtained based on informed consent.3
CISCRP began a program for communicating trial results six years ago, partly in response to demand from study volunteers of whom 97% want to receive the results of their clinical trial, but fewer than 10% ever do see the results, Getz says.4
“The FDA, for a long time, has been encouraging the transparency and disclosure of trial results information, and they’ve been supportive of nontechnical, lay language,” Getz says. “The European Union jumps into the fray, and they’re in synch with the FDA’s perspective, but they’re the first to come out and say that within one year after a trial has ended, they want to see sponsors making a summary and giving results that are understandable to the lay public.”
CISCRP has helped lay the framework for providing generalized clinical trial results to study volunteers. “I’m very supportive of the work CISCRP and others have done in laying the framework for how we should be doing this,” Riddle says.
“This seems to be the right moment to have industry sponsors really embrace this idea and to have the research ethics community and IRB community facilitate the return of results in some fashion,” he adds.
For example, as NIH pushes for more central IRB reviews, the IRB that reviews the protocol could be in the best position to review the layperson summary created to share the study’s results, Riddle suggests. “They would be in a position to help facilitate the distribution of the layperson summary and to get results back to a majority of sites.”
- Attachment D: Recommendations regarding return of general research results. U.S. Department of Health & Human Services. Website:
- Brauburger K, Sroka-Saidi, K, Schindler TM. AMWA. 2015;30(2):60-63.
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. Published online: http://bit.ly/2cpv09r.
- Bahador B, Farides-Mitchell J, Hallinan Z, et al. Patient lay summaries: meeting the ethical obligation to share trial results with study volunteers. Poster presented at the 2015 PRIM&R Advancing Ethical Research Conference, held Nov. 12-15, 2015, in Boston.
The European Union soon will require investigators to give people the kind of transparent, easy-to-access clinical trials information they’ve been conditioned to expect in the age of Google.
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