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Most clinical trial participants find benefits outweigh risks in sharing personal data

Most participants in clinical trials believe the benefits of broadly sharing person-level data outweigh the risks, according to new research by Stanford Medicine's Michelle Mello and Steven N. Goodman. 

And despite low levels of trust in pharmaceutical companies, most of those who take part in clinical trials are willing to share their data with the drug firms.

The Stanford researchers surveyed 771 current and recent participants from a diverse sample of clinical trials at three academic medical centers in the United States. They asked about the practice of making personal data collected in medical research studies widely available, after information that could identify individual participants is removed. Nearly 80 percent of those surveyed responded to the questions — and fewer than 8 percent of the respondents felt that the potential negative consequences of data sharing outweighed the benefits.

Some 93 percent of those surveyed said they were very or somewhat likely to allow their data be shared with university scientists, and 82 percent were either very or somewhat likely to share with scientists in for-profit companies. They found that the willingness to share was high regardless of the purpose for which their data would be used, with the exception of litigation.

Although some researchers and trial funders have worried that participants might object to data sharing as an invasion of privacy, the respondents’ greatest concern was that “data sharing might make others less likely to enroll in clinical trials,” Stanford Health Policy's Michelle Mello and her co-authors write in The New England Journal of Medicine. “Less concern was expressed about discrimination (22 percent) and exploitation of data for profit (20 percent.)”

Mello is a professor of law at Stanford Law School and a professor of health research and policy at Stanford Medicine. Her co-authors are Van Lieou and Steven N. Goodman, a professor of medicine and of health research and policy at Stanford Medicine.

The authors acknowledge there is no turning back from clinical data sharing.

“We are rapidly moving toward a world in which broad sharing of participant-level clinical trial data is the norm,” they wrote.

The European Medicines Agency has implemented a policy to expand public access to data concerning products it approves, and the Food and Drug Administration is considering expanding access to data pooled within a product class. Major research sponsors and journal editors have begun promoting data sharing, and the National Institutes of Health now requires all of its grantees to share data.

Pharmaceutical industry associations have committed to making data more accessible, and several data platforms are now available, such as the Yale Open Data Access Project.

Mello said she was somewhat surprised by the survey results, “given the amount of consternation one hears at conferences about data sharing. Interestingly, nearly half our sample had experienced a breach of their personal data privacy in another context, yet they were still willing to share their clinical trial data.”

Then again, she said, people who take part in clinical trials may be special.

“I suspect that clinical trial participants may be different from the public at large. They are already incurring risks to benefit science by dint of their trial participation.”

Most of those participants, along with clinical researchers, believe the benefits of sharing data include accelerating scientific discovery and improving accurate reporting of trial results.

Yet some investigators and industry sponsors of clinical trials are leery of the swift move toward broad data sharing, the authors note, because of “potential harm to research participants,” the authors wrote. “Investigators express worries that participants’ privacy cannot be adequately protected, particularly in light of the fact that experts have demonstrated that it is possible to reidentify participant-level data.”

Furthermore, they said, some pharmaceutical companies have warned that data sharing could chill willingness to participate in trials, thereby delaying the availability of new therapies. In fact, 31 percent of those surveyed were somewhat or very concerned about having their personal information stolen.  Nevertheless, most felt the benefits of data sharing were more important. 

“Reaching a world in which the sharing of clinical trial data is routine requires surmounting several challenges — financial, technical, and operational,” the authors concluded. “But in this survey, participants’ objections to data sharing did not appear to be a sizeable barrier.”