Patient Perspectives on Seeing Trial Results

This article is the third in a series on the results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2017 Perceptions & Insights Study.

Conversation Starters

When patients around the world are asked what they perceive to be the greatest benefit of participating in a clinical research study, they rank altruistic reasons such as the ability to help advance science and the treatment of a disease (26%) or to help save or improve the lives of other patients living with the same disease (26%) the highest. The third-greatest benefit they mention is the chance to improve one’s own disease or condition (15%). While clinical trial sponsors are unable to guarantee that a study drug will be effective and improve one’s condition, they can take steps to make patients aware of their contributions in these areas and convey that they are a valued research partner. A critical initial step is providing patients a summary of the general study results to allow them to better understand how their participation contributed to the development of a new medical therapy. Eventually, sponsors will share patients’ individual studies to help inform how the study medication may be impacting their condition.  

Knowing whether or not one will receive a study summary at the end of the individual’s participation is an important factor in the decision to participate in a clinical trial. An overwhelming majority (91%) of patients feel this is “very” or “somewhat” important. African American patients are the most likely to rank knowing whether they would receive a summary of their study results before making a decision to participate as “very important” (66%) when compared to White (56%) or Asian (50%) populations. This suggests that mistrust still exists within this particular population. Sharing trial results could be a new way to build trust and to help this community feel more informed about the benefits and risks of their participation and to ultimately increase engagement.

When asked what information patients would be the most interested in receiving during their participation in a clinical trial, individual study results (73%) and a summary of the study results (72%) are listed as the top two pieces of information by the general population. North Americans are more likely to find it “very important” to receive this information than other regions, perhaps due to an increased desire to be more proactive with their own health. Additionally, patients over 55 years of age are also more likely to want to receive their individual study results (77%) than younger patients (67%), possibly because older people are more likely to be living with a condition.

There is also evidence suggesting that the severity of one’s condition shapes expectations in terms of what these patients hope to get out of clinical trial participation. People who report living with very severe conditions are significantly more likely than healthy volunteers to participate in a study because it would help advance treatments for the disease they were managing (73% vs. 33%), or help them obtain better treatment for their condition (70% vs. 8%). Furthermore, patients who rate their condition to be very severe are more likely to mention that it is “very important” to receive a summary of their individual study results (73%) when compared to healthy volunteers (60%). The significance this population places on receiving study results may stem from their heightened desire to identify an effective treatment for their condition and their ability to empathize with others living with the same condition, which would, in turn, peak their interest to see how much of an impact their participation in a clinical research study was making on the treatment of the disease as a whole.

Even though there is substantial evidence that both pharmaceutical companies and patients would benefit from the sharing of clinical trial results, only 30% of those who participate in a study report ever having received a summary of the study results at the end of their participation. Interestingly, patients who participate in Phase I studies report receiving study results more often than do patients who participate in later study phases. This could be due to a lack of therapeutic benefit for Phase I participants since they are usually healthy and participating for purely altruistic reasons, or because of the lower volume of patients involved in these trials, making it easier for sponsors to gather and disseminate this information.

The “So What?”

The disparity between patients’ desire to receive study results and the low frequency at which they actually receive them highlights opportunities to make patients more informed about the benefits and risks of participation at various stages of their clinical trial experience. It additionally communicates to the patient that the study staff appreciate their participation, and are making an effort to respect them as a valued research partner. Patients who report having received updates on the results of the study at the end of their participation are significantly more likely to report that they “trusted pharmaceutical companies a lot” (30%) to give full and accurate information about the health risks and benefits of new medicines than do those who report not receiving results once their trial participation was over (23%). By providing patients with their clinical trial results, pharma companies can address the motivations that make clinical research participation meaningful to patients, as well as help build the public’s trust in the clinical research enterprise.

CISCRP Research Services: Nova Getz, Annick Anderson, Jasmine Benger

Study methodology 

The objectives of this study are to establish routine global assessments of public and patient perceptions, motivations, and experiences with clinical research participation to monitor trends and identify opportunities to better inform and engage the public and patients as stakeholders and partners in the clinical research enterprise. 

Between May and July 2017, CISCRP conducted an online international survey. The survey instrument was based in part on questions posed in past surveys. CISCRP received input and support from pharmaceutical, biotechnology, and contract research organizations (CROs), and from investigative sites. A total of 12,427 respondents completed the survey. The online questionnaire was reviewed by an ethical review committee. CISCRP collaborated with Acurian, Clariness, CureClick, HealthUnlocked, and Quintiles to reach and engage respondents.

For more information about CISCRP’s 2017 Perceptions & Insights Study and to download reports, visit www.ciscrp.org.