Abstract

METHODS

RESULTS

SAMPLE CHARACTERISTICS

Completed surveys were received from 771 of the 978 invited trial participants (79%) and included 350 mailed surveys and 421 surveys completed in the clinic (Section 1 in the Supplementary Appendix). Respondents were fairly evenly distributed across the three academic medical centers (33%, 27%, and 40%) and were drawn from 119 different trials. Percentages based on the 771 respondents have a 95% confidence interval no wider than ±3.6 percentage points.

Table 1, and Table S6 in the Supplementary Appendix, show the characteristics of the sample. Within the previous 2 years, 42% of the respondents had participated in a clinical trial as a person with the health condition being studied, 55% as a healthy volunteer or person at risk for the studied health condition, and 3% as both. The two most common topics studied in the trials were diabetes and issues related to nutrition, weight, and vitamin supplementation. A total of 90% of respondents were trial participants themselves, and 7% were parents of participants. More than 94% of the respondents reported having had positive experiences as clinical trial participants. Half were motivated to participate in the trial by the prospect of a health benefit, 33% by altruism, and 16% by other factors.

Table 1

Sample Characteristics as Reported in the Survey.^*

Characteristic	No. of Participants/Total No. (%) (N = 771)
Female sex	380/762 (49.9)
Age
<25 yr	63/762 (8.3)
25–44 yr	177/762 (23.2)
45–64 yr	286/762 (37.5)
≥65 yr	236/762 (31.0)
Hispanic ethnic group	101/759 (13.3)
Race
White	518/768 (67.4)
Black or African American	113/768 (14.7)
American Indian or Alaskan Native	51/768 (6.6)
Asian	25/768 (3.3)
Other	61/768 (7.9)
Education
Less than high school	40/752 (5.3)
High-school diploma	125/752 (16.6)
Some college	206/752 (27.4)
College degree	238/752 (31.6)
Graduate degree	143/752 (19.0)
Annual family income
Less than $15,000 to $24,999	173/742 (23.3)
$25,000 to $54,999	206/742 (27.8)
$55,000 to $99,999	189/742 (25.5)
$100,000 or higher	174/742 (23.5)
Health status
Excellent	168/757 (22.2)
Good	420/757 (55.5)
Fair	156/757 (20.6)
Poor	13/757 (1.7)
Trial topic
Nutrition, weight, or vitamins	172/771 (22.3)
Diabetes	172/771 (22.3)
Cardiovascular disease	71/771 (9.2)
Aging, neurodegenerative disease, or memory	64/771 (8.3)
Tobacco use	52/771 (6.7)
Liver disease	49/771 (6.4)
Mental illness	41/771 (5.3)
Cancer	39/771 (5.1)
Kidney disease	26/771 (3.4)
Other	85/771 (11.0)
Overall experience as a trial participant
Very positive	573/752 (76.2)
Somewhat positive	136/752 (18.1)
Neither positive nor negative	34/752 (4.5)
Somewhat negative	9/752 (1.2)
Very negative	0

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^*All characteristics with exception of trial topic were reported by the participant in the survey. Percentages may not total 100 because of rounding. Further details are provided in Section 6 in the Supplementary Appendix.

PERCEIVED RISKS OF DATA SHARING

For 9 of 11 potential consequences of data sharing, less than 10% of the respondents said they were “very concerned” and less than one third were “very” or “somewhat” concerned about the risk (Fig. 1). A total of 20% to 26% of the respondents were very or somewhat concerned about discrimination, reidentification, and exploitation of data for profit. Respondents were more concerned that data sharing could deter people from enrolling in clinical trials (37%), that companies might use the information for marketing purposes (34%), or that their data could be stolen (30%). Asked to select the most important potential risk, respondents expressed divergent views, with the most common choices being that the information might be stolen (15%) or used for marketing purposes (11%) and that others might be more reluctant to enroll in clinical trials if they knew their data would be shared (10%) (Table S7 in the Supplementary Appendix).

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Figure 1

Level of Concern about Potential Consequences of Data Sharing

Shown are the responses to an item worded as “How concerned are you about the following potential consequences of sharing anonymous, individual clinical trial data?” Numbers were rounded to the nearest tenth. The accuracy (95% confidence interval) of the percentages close to 50% is ±3.6 percentage points, diminishing to ±2.2 percentage points for percentages close to 10%.

PERCEIVED BENEFITS OF DATA SHARING

Strong majorities of respondents (67% to 82%) believed that data sharing would yield “a great deal” or “a lot” of several benefits (Fig. 2). In contrast, 43% believed it would help lawyers prove their case in product liability lawsuits. When respondents were asked to choose the most important benefit of data sharing, the most popular choices were making sure people’s participation in clinical trials leads to the most scientific benefit possible (18%) and helping to get answers to scientific questions faster (17%) (Table S8 in the Supplementary Appendix). More than 85% of respondents expected that scientists in universities and other not-for-profit settings would benefit “a great deal” or “a lot” from data sharing; 81% of respondents had this expectation for physicians taking care of patients, 79% for companies developing medical products, and 72% for patients (Table S9 in the Supplementary Appendix)

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Figure 2

Perceived Benefits of Data Sharing

Shown are the responses to an item worded as “How much do you think sharing anonymous, individual clinical trial data can . . . .” Numbers were rounded to the nearest tenth. The accuracy (95% confidence interval) of percentages close to 50% is ±3.6 percentage points, diminishing to ±2.2 percentage points for percentages close to 10%.

OVERALL SUPPORT FOR DATA SHARING

In response to a question at the end of the survey, 82% of respondents indicated that they perceived that the benefits of data sharing outweighed the negative aspects, 8% felt the negative aspects outweighed the benefits, and 10% considered them equal (Table S10 in the Supplementary Appendix).

A total of 93% of respondents said they were very (69%) or moderately (24%) likely to allow their clinical trial data to be shared with scientists in universities and other not-for-profit organizations (Table 2), and 4% were very or somewhat unlikely to share. Although respondents had less trust in drug companies (18% trusted them a great deal or a lot) and health insurance companies (15%) than in universities (63%), 82% reported that they would be very or somewhat willing to share data with for-profit companies, whereas 8% were very or somewhat unwilling to share (Table 2, and Table S11 in the Supplementary Appendix).

Table 2

Willingness of Clinical Trial Participants to Share Their Data, According to Type of Use and Recipient.^*

Type of Use or Recipient	Very Likely	Somewhat Likely	Neither Likely nor Unlikely	Somewhat Unlikely	Very Unlikely
	percent of respondents
Type of use
To help patients and groups of patients learn more about health problems that affect them	77.8	18.8	2.6	0.4	0.4
To do research on health problems that affect my family or me	78.3	17.1	3.2	1.1	0.5
To do research that will help others	79.9	17.1	2.0	0.4	0.7
To help get answers to scientific questions faster using information that others have already gathered	72.2	22.6	3.4	1.2	0.5
To help scientists check the accuracy of research results announced by other scientists or companies (by re-doing the analyses)	70.9	22.6	3.8	1.5	1.2
To learn more about diseases that only a small number of people have (by combining data from many clinical trials)	69.1	22.1	5.9	1.7	1.2
To help lawyers prove their case in lawsuits claiming that medical products are unsafe	27.9	24.5	26.9	12.7	8.0
Recipient
Scientists in universities and other not-for-profit organizations	69.2	24.0	3.3	1.7	1.8
Scientists in companies developing medical products, such as prescription drugs	53.4	28.5	10.6	5.4	2.1

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^*Shown are the responses to items worded as “How likely would you be to allow your anonymous, individual clinical trial data to be used in the following ways?” (for type of use) or “How likely would you be to allow your anonymous, individual clinical trial data to be shared with . . . .” (for recipient). Numbers were rounded to the nearest tenth. The accuracy (95% confidence interval) of percentages close to 50% is ±3.6 percentage points, diminishing to ±2.2 for percentages close to 10%.

Willingness to share data varied little according to the purpose for which it would be used — with the exception of its use in lawsuits, although a majority of respondents were still willing to share even for that purpose (Table 2). No appreciable differences were found between uses that did and uses that did not benefit the participant directly or between uses for verifying previous research results and uses for making new discoveries.

Among the write-in comments, the most dominant theme was the need to help others as much as possible. Many commenters expressed confidence in the deidentification of data. Several urged greater cooperation and less competition among scientists.

DISCUSSION

In this study assessing the views of clinical trial participants on the sharing of participant-level clinical trial data beyond genomic information, several key messages emerged. First, most of the clinical trial participants in our study believed that the benefits of data sharing outweighed the potential negative aspects and were willing to share their data. Their willingness to share was high regardless of the way in which the data would be used, with the exception of litigation, and it extended to uses that involved no prospect of direct benefit to themselves or their family members. Despite low levels of trust in pharmaceutical companies, most trial participants were willing to share their data with them.

The respondents’ lack of differentiation among different data users and uses contrasts with previous study findings related to biobank participation. Those studies consistently showed substantially less willingness to share biospecimens with researchers in for-profit companies than with university researchers.^45–53 One study showed the same effect for sharing information from electronic health records (EHRs) for research purposes.⁵⁴

The willingness of the respondents in our study to share clinical trial data was greater than that found in many previous studies that involved participants’ attitudes toward research use of biospecimens or EHR data.^{40,41,54–56} Expanding access to clinical trial data shares some ethical complexities with biobanking, such as how to obtain meaningful informed consent, but genetic information raises special concerns.^45,57 On the other hand, clinical trial data include information from medical records and questionnaires that reveals much more about participants than biospecimens. Some such information — for example, sexual orientation or substance use — may carry serious social risks.³⁸ A further consideration is that with rare exceptions,⁵⁸ biobanking studies presume that an institutional review board will approve future uses of the data — a safeguard that may not be present for sharing of clinical trial data. Finally, biobanking and EHR studies have generally presumed that the data would be used by qualified researchers, but some proposals for “open access” data sharing are not so limited.^1,4

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. 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. Their familiarity with physician-researchers may impart especially high trust in research and researchers.⁵⁹ Indeed, nearly all of our respondents reported very positive experiences as trial participants.

Our findings are broadly consistent with other literature on engagement in clinical trials in underscoring the idea that altruism as well as self-regarding motivations influence participation decisions.^60,61 In write-in comments, many respondents expressed the view that agreeing to broad use of their data was inherent in agreeing to participate in research.

A second finding of our study is that even when presented with a list of negative potential consequences, most trial participants do not express substantial concern about the risks of data sharing. On average, across the negative consequences they considered, approximately 8% of respondents were very concerned and 17% somewhat concerned. However, a substantial minority of respondents did express some concern, especially about discouraging others from volunteering for trials (37% somewhat or very concerned), having information used for marketing (34%), and having information stolen (31%). Many potential harms that trial sponsors and investigators worry a great deal about, such as reidentification and discrimination, were not of great concern to a sizable majority of participants, a finding that differs from surveys about biobanking that highlight these issues as leading concerns.⁶²

Third, multivariable analysis revealed few differences in views across participant subgroups. Despite concern that distrust in research among African Americans may extend to data sharing,^1,46,58,63 we found no significant differences according to race. Because few of our respondents expressed negative views of data sharing, only large subgroup differences were detectable.

Our study had limitations. The respondents were relatively healthy: approximately a quarter characterized their health status as fair or poor. Although health status was not a significant predictor of attitudes in our models, a less healthy group of respondents might have reported different views. Our response rate was high, but we cannot exclude the possibility of nonresponse bias. Some people may decline to enroll in clinical trials out of concern that their data might be shared, and they are not represented in our sample. The survey concepts were complex, and although we conducted pilot work to clarify questions, some respondents may have had comprehension difficulties or lacked sufficient understanding of data sharing to meaningfully assess the potential consequences. Finally, respondents’ actual willingness to share their data might be lower than their hypothetical willingness. Previous research on genomic data, however, has shown the reverse.^59,62

Our findings suggest that concerns about trial participants’ attitudes toward data sharing invoked by companies and investigators who caution against it may be exaggerated. Participants perceive data sharing to have many benefits, and most are willing to share their data. Finally, participants’ concern about the use of their data for marketing is worth addressing. Data repositories could require data requesters to attest that no marketing use will occur, and consent documents could offer assurances about this requirement.

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

Supplementary Material

Acknowledgments

Footnotes

References