Returning a layperson summary of study results to research volunteers is the right thing to do that also could benefit the research community, several human research protection experts say.
“As a society, you start to see the desire in those who want to give back or have altruistic activities to know what their contribution means,” says James Riddle, MCSE, CIP, CPIA, vice president of client services at Kinetiq, a division of Quorum Review IRB in Seattle.
It’s a trend that’s similar to how people increasingly want to know how their financial gifts to nonprofits are being used, he notes.
“People ask, ‘What does this gift of my time, money, resources, mean, and does it do anything?’” Riddle says. “And it spills over to their participation in clinical trials research: They want to know what it meant and whether it made a difference, and if we don’t provide any feedback, then we lose the opportunity to engage them in the next study.”
The human research protection community has a general consensus of increasing awareness and openness in research, and this contributes to a growing trend toward returning results, says Mitchell Parrish, JD, RAC, CIP, vice president of legal affairs for Kinetiq.
“We think it’s a good thing to return results to individuals in language that’s understandable to them,” Parrish says. “This improves patient engagement and shows respect for their participation.”
Engaging research volunteers through returning generalized results also might help improve the industry’s study recruitment rates.
As clinical trials become increasingly complex and difficult to execute, success rates are at a nadir and recruitment rates are continuing to drop, 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).
“We’re targeting smaller and smaller markets with very targeted subpopulations, which makes it harder to recruit,” Getz explains. “We need a new model, a new approach, and there’s a moral imperative that patients have the right and ability to be engaged in this process.”
CISCRP has a communicating trial results program, which has more than 30 sponsor companies. It helps organizations disclose results by providing post-trial communication, convening independent editorial panels to prepare lay language summaries, producing final summaries, and distributing printed material to site staff for dissemination.
“We have some companies now that are providing trial results to all their study volunteers through the CISCRP program,” Getz says. “Our goal is to create a standard practice and help, if possible, every single company do this.”
CISCRP’s standard operating procedures (SOPs) can be integrated into a company’s own trial results development activity.
“We engage the investigative sites and make sure the principal investigator and study coordinator are aware that the results have been made available,” Getz says. “We always do this with the research sponsor’s support and technical summary, and the lay editorial board develops the plain language summary, which is reviewed by scientific experts for accuracy.”
The bottom line is that giving research volunteers the results is a way to thank them for their service. “We view this as the ultimate act of appreciation, and a critical part of the whole patient and study engagement process,” Getz says.