- The vast majority of clinical trial participants approve of health data sharing among researchers as long as the appropriate safeguards are in place, according to new findings in the New England Journal of Medicine (NEJM).
Despite the high number of patient EHRs compromised in healthcare data breaches in 2018, few patients have reservations about allowing university scientists or for-profit companies to access their health data.
According to Mello et al., only 8 percent of a total number of 771 surveyed clinical trial participants feel the potential negative consequences of data sharing outweigh the benefits.
Researchers issued a 10-page questionnaire to clinical trial participants from 119 different trials at three academic medical centers to gain insight into respondents’ views on sharing de-identified health information. Respondents had mostly participated in clinical trials studying diabetes, nutrition, weight, and vitamin supplementation.
More than 94 percent of respondents reported having positive experiences as clinical trial participants, and half were motivated to participate in the trial by the possibility of reaping health benefits.
The majority of study participants saw clear benefits to sharing data — over 85 percent of respondents expected scientists in universities and other not-for-profit settings would benefit significantly from data sharing, while 81 percent predicted physicians caring for patients would benefit from data sharing.
Seventy-nine percent expected companies developing medical devices or products would benefit, and 72 percent saw benefits for patients.
While most participants saw the benefits of contributing health data to researchers for clinical trials, few were concerned by 11 listed potential consequences of health data sharing. According to researchers, less than 10 percent of respondents reported being ‘very concerned about 9 of 11 potential consequences of data sharing, while less than one third were “very” or “somewhat” concerned about potential risks.
Some of the potential risks of data sharing included the possibility that someone could hack the information and identify a clinical trial participant, scientists could use the data to do poor-quality research, participants could be discriminated against if they were linked back to their information, and that scientists and companies could have less incentive to invest time and money in clinical trials if data is shared.
The highest number of respondents reported being concerned that their data sharing could deter other people from enrolling in clinical trials (37 percent). Thirty percent of people were concerned their data could be stolen.
Overall, willingness to share health data was high among nearly all participants — even with for-profit companies.
“Despite low levels of trust in pharmaceutical companies, most trial participants were willing to share their data with them,” stated researchers in a discussion of the report.
According to researchers, clinical trial participants seem more willing to share health data than participants in previous studies asked about their willingness to share biospecimens or EHR data.
“The values and concerns of clinical trial participants may differ from those of the general public, patients in general, or other populations surveyed in biobanking and EHR studies,” suggested researchers.
“Clinical trial participants typically constitute a small proportion of the people who are eligible for participation and may represent those who are least bothered by data sharing and most enthusiastic about contributing to science,” the team added.
Additionally, many clinical trial participants shared a belief that the potential for their data to be shared was part of the agreement to participate in research in the first place.
“Our findings suggest that concerns about trial participants’ attitudes toward data sharing invoked by companies and investigators who caution against it may be exaggerated,” stated researchers. “Participants perceive data sharing to have many benefits, and most are willing to share their data.”
However, researchers noted many participants were concerned their data would be used for marketing purposes.
“Data repositories could require data requesters to attest that no marketing use will occur, and consent documents could offer assurances about this requirement,” researchers recommended.
Ultimately, hesitance to engage in health data sharing should not be considered a substantial barrier to data access, exchange, or use.