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

June 6, 2018, Stanford University Medical Center
Credit: CC0 Public Domain

Most participants in clinical trials believe the benefits of broadly sharing person-level data outweigh the risks, according to a new study by Stanford University researchers.

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

The study will be published in the June 7 issue of The New England Journal of Medicine. The lead author is Michelle Mello, JD, Ph.D., professor of law and of health research and policy. Steven Goodman, MD, Ph.D., professor of medicine and of health research and policy, is the senior author.

The researchers surveyed 771 current and recent participants from a diverse sample of clinical trials at three in the United States. They asked about the practice of making personal data collected in medical research widely available after the removal of information that could identify individual participants. 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 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 allow their data to be share with scientists at for-profit companies. The researchers found that the willingness to share was high regardless of the purpose for which their data would be used, unless that purpose was 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," the authors wrote. "Less concern was expressed about discrimination (22 percent) and exploitation of data for profit (20 percent.)"

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.

Expanding access to data

Major research sponsors and journal editors have begun promoting data sharing, and the National Institutes of Health now requires its grantees to describe how they will share their data with others.

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 in another context, yet they were still willing to share their clinical trial data," she said.

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," Mello said. "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.

Companies leery of data sharing

Yet some investigators and industry sponsors of are leery of the swift move toward broad data sharing 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, the authors wrote, some pharmaceutical companies have warned that data sharing could chill people's 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 is routine requires surmounting several challenges—financial, technical and operational," the authors wrote. "But in this survey, ' objections to data sharing did not appear to be a sizeable barrier."

Explore further: Lack of voluntary data sharing from industry-funded clinical trials

Related Stories

Lack of voluntary data sharing from industry-funded clinical trials

June 28, 2016
In a study appearing in the June 28 issue of JAMA, Isabelle Boutron, M.D., Ph.D., of Paris Descartes University, Paris, and colleagues investigated the proportion of randomized clinical trials (RCTs) registered at ClinicalTrials.gov ...

Leading medical journals propose mandate on clinical data sharing

January 20, 2016
The International Committee of Medical Journal Editors (ICMJE) proposes new rules that will require authors to share clinical trial data as a prerequisite for their manuscripts to be considered for publication. The goal is ...

Use of open access platforms for clinical trial data

March 22, 2016
In a study appearing in the March 22/29 issue of JAMA, Ann Marie Navar, M.D., Ph.D., of Duke University Medical Center, Durham, N.C., and colleagues examined how shared clinical trial data are being used. Concerns over bias ...

The BMJ's data sharing policy now applies to all clinical trials

July 1, 2015
From today (1 July 2015) The BMJ requires sharing of individual patient data for all clinical trials.

Yale YODA Project announces first availability of medical device trial data

January 14, 2015
The Yale University Open Data Access (YODA) Project is announcing the first-ever broad availability of clinical trial data for medical devices and diagnostics by a company. This historic expansion of data sharing is made ...

Researchers, pharma experts offer recommendations to expand access to clinical trial data

October 21, 2013
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 ...

Recommended for you

Adding refined fiber to processed food could have negative health effects

October 19, 2018
Adding highly refined fiber to processed foods could have negative effects on human health, such as promoting liver cancer, according to a new study by researchers at Georgia State University and the University of Toledo.

Juul e-cigarettes pose addiction risk for young users, study finds

October 19, 2018
Teens and young adults who use Juul brand e-cigarettes are failing to recognize the product's addictive potential, despite using it more often than their peers who smoke conventional cigarettes, according to a new study by ...

Self-lubricating latex could boost condom use: study

October 17, 2018
A perpetually unctuous, self-lubricating latex developed by a team of scientists in Boston could boost the use of condoms, they reported Wednesday in the journal Royal Society Open Science.

How healthy will we be in 2040?

October 17, 2018
A new scientific study of forecasts and alternative scenarios for life expectancy and major causes of death in 2040 shows all countries are likely to experience at least a slight increase in lifespans. In contrast, one scenario ...

Adequate consumption of 'longevity' vitamins could prolong healthy aging, nutrition scientist says

October 16, 2018
A detailed new review of nutritional science argues that most American diets are deficient in a key class of vitamins and minerals that play previously unrecognized roles in promoting longevity and in staving off chronic ...

Study finds evidence of intergenerational transmission of trauma among ex-POWs from the Civil War

October 16, 2018
A trio of researchers affiliated with the National Bureau of Economic Research has found evidence that suggests men who were traumatized while POWs during the U.S. Civil War transmitted that trauma to their offspring—many ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.