A New Look at Global Study Volunteer Experiences with Informed Consent

The Center for Information & Study on Clinical Research Participation (CISCRP), an independent non-profit organization, recently conducted a global assessment of study volunteer experiences with the informed consent process. The results of this study show wide variation between study volunteers by age group and by geographic region and suggest opportunities for general as well as targeted improvement.

The online study was conducted among a global community of health information seekers and research participants. Overall, nearly 6,000 people provided complete responses, making CISCRP's 2013 Perceptions & Insights Study one of the largest international surveys ever conducted among clinical research participants.

It has been nearly 10 years since such an assessment has been conducted. During that time, protocol complexity has increased dramatically. In 2012, according to the Tufts Center for the Study of Drug Development, in a typical Phase III protocol each study volunteer had to complete nearly 170 procedures during the course of 11 visits across 230 days. This represents more than a 60% increase in the number of procedures performed in 2002. Patients from an average of 34 countries and 196 research centers were recruited for that typical Phase II clinical trial, up from 11 countries and 124 research centers 10 years ago. And with increasing focus on stratified patient populations, in 2012 each study volunteer had to meet an average of 50 eligibility criteria in order to participate in that typical Phase III study—up from an average of 31 inclusion and exclusion criteria ten years ago.

Despite efforts to simplify the informed consent form and improve comprehension during the past decade, in this latest study a higher proportion of study volunteers report finding the informed consent form difficult to understand compared with the results of past surveys. In addition, a significantly higher proportion of study volunteers in both South America and Asia Pacific find the informed consent form difficult to understand ('somewhat difficult' and 'very difficult' combined). The vast majority of study volunteers, overall and by region, report that their clinical trial expectations were ultimately met. What follows is a discussion of summary findings from the CISCRP 2013 Perceptions & Insights Study. For a series of detailed reports on this latest study, organized by topic, please visit www.ciscrp.org/.

About the study

CISCRP conducted the Perceptions & Insights Study online in the spring of 2013, following feedback from a global community of patients and the public indicating their preference for receiving and completing a survey using this distribution channel. The survey instrument included questions posed in past surveys conducted by Harris Interactive, CenterWatch, and CISCRP, as well as new questions. Representatives from pharmaceutical and biotechnology companies, contract research organizations and investigative sites provided input into the questionnaire design. A central ethical review committee reviewed the final survey instrument.

CISCRP collaborated with Acurian for its help in reaching and engaging respondents around the world. Acurian maintains a proprietary database of people who have explicitly opted-in—via online and offline consumer health surveys—to receive healthcare information on specific diseases and clinical trial notifications.

A total of 5,701 international respondents completed the survey with the highest concentration (75% or n=4,286) based in North America; 15% (n= 837) based in Europe, 5% (n=233) from South America and 5% (n=329) from Asia-Pacific. A majority of respondents (58%) are female. Approximately four-out-of-ten respondents had participated in a clinical trial prior to completing the online survey. Respondents diagnosed with an illness represented a very broad mix of disease indications. Approximately 20% (n=1,042) of respondents were under the age of 34; and the majority (n=4,659) were 35 year and older.

Global differences in comprehension

The vast majority of study volunteers responding to this survey reported having an initial informed consent review experience using a printed form. Only 9% reported having a video or electronic informed consent review. The results of this 2013 study should serve as a reasonable baseline for assessing the impact of e-consent forms and other progressive approaches as their adoption increases.

Overall, nearly six-out-of-ten study volunteers initially read the informed consent form by themselves. Outside of North America, due in part to varied levels of literacy and to greater dependency and trust in their relationships with medical professionals, a significantly lower percentage of study volunteers—30% of South American, 46% of European and 23% of Asia-Pacific—report independently reading the informed consent form at the outset of their participation.

Approximately three-out-of-four study volunteers reviewed the informed consent form with study staff, with most reviewing the form with a study coordinator. A significantly higher percentage of study volunteers in South America and Asia-Pacific review the informed consent form with the principal investigator (39% and 48% respectively). One-in-ten study participants reports they do not review the informed consent form with anyone. Interestingly, nearly double that percentage–18%–of study participants in South America reported that no one reviewed the informed consent with them suggesting an opportunity for attention and remediation.

The majority (85%) of study participants, overall, say they are "Somewhat Satisfied" or "Very Satisfied" that their questions were answered during the informed consent form review process, and 15% say that they were not satisfied. A significantly higher percentage (approximately one-third) of study volunteers outside North America is less satisfied that their questions were answered during the informed consent review process. And a much higher proportion (28%) of study volunteers in the 18-34 year-old age group were also less satisfied that their questions were answered during the informed consent form review.

One-out-of-five study volunteers reports finding the informed consent form to be "Somewhat Difficult" or "Very Difficult" to understand. Compared to past surveys conducted among global communities of study volunteers, this is the highest percentage ever recorded. A very high percentage of study participants in South America (63%) and in Asia-Pacific (69%) found their informed consent forms difficult to understand suggesting that a number of factors including language translation quality and study staff effectiveness in conducting form review are falling short. Four-out-of-ten study participants in Europe also found their informed consent forms difficult to understand.

The results of this study also suggest that younger study volunteers may require customized approaches to informed consent form development and review. Half of 18-34-year-old study participants worldwide found their informed consent forms "Somewhat Difficult" or "Very Difficult" to understand. Among 55-year-olds and up, 90% reported that the informed consent form was "Not at all Difficult" to understand.

Although a high percentage of study participants outside of North America and in the 18-44 age group consider the informed consent form difficult to understand, a relatively high percentage of all study volunteers—including these subgroups—say that they were "Somewhat More Willing" or "Much More Willing" to participate following their review of the informed consent form. A significantly higher percentage of study volunteers in Europe (59%) and Asia Pacific (68%) said that that they were more willing to participate following their review of the informed consent form. This review process is likely contributing to volunteer rapport with the study staff. The protocol's scientific complexity and its stringent eligibility requirements may also play a part in elevating study volunteer interest in participating.

Conclusion

The results of the 2013 Perceptions & Insights Study provide insights into opportunities to build on and improve patient experiences. A relatively small proportion of study volunteers are not reading or reviewing the informed consent form with wide differences observed in emerging regions suggesting an inconsistently executed process. The results also show that, compared to historical levels, an even higher percentage of volunteers find the informed consent form difficult to understand.

But overall, the informed consent process receives generally strong marks in terms of study volunteer satisfaction that their questions were answered and that their expectations of the clinical trial were met or exceeded.

Kenneth A. Getz MBA, is the Director of Sponsored Research at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, e-mail: [email protected]