Education and Satisfaction Disparities Evident Among European Patients, Public

Good news: recent research among a global public and patient community shows general improvement in attitudes and perceptions about clinical research. Bad news: there is one group-patients and the public in Europe-with consistently more negative opinions and views that appear to be getting worse.

Kenneth A Getz.

Kenneth A. Getz

Based on nearly 850 responses, a recent Center for Information & Study on Clinical Research Participation (CISCRP) study finds that the European public considers clinical research to be riskier than does the public in many other global regions. Moreover, the European community shows the lowest self-assessed general knowledge about the clinical research process and the lowest level of willingness to participate in clinical trials. Among European study participants, a higher percentage finds the informed consent form review difficult to understand relative to their geographic counterparts. And study participants in this community are among those least willing to consider participating in another clinical research study.

Although we can speculate, the root causes of the problem are not completely clear. A closer look at the attitudes and perceptions in this particular community strongly indicate that much more focus and attention is required to address underlying concerns and implement targeted outreach, education, and new patient engagement initiatives.

Perceptions & insights

Between January and March 2013, CISCRP-an independent non-profit organization-developed and conducted the "Perceptions & Insights Study" to resume and establish routine global assessment of public and patient perceptions, motivations, and experiences with clinical research participation. The online study was conducted among a global community of health information seekers and research participants. A total of 5,701 international respondents completed the survey, making it one of the largest international clinical research surveys ever conducted. Given the sample size, generally a three to five percentage point difference between subgroup values is significant at the p<.05 level.

To reach a global community of respondents, CISCRP collaborated with Acurian (now part of PPD), a worldwide provider of patient recruitment and retention services-for its help in reaching and engaging respondents. 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.

The highest concentration (75%) of respondents resides in North America; 15% are based in Europe, 5% from South America, and another 5% from Asia-Pacific. A majority of respondents (58%) are female. Approximately four out of 10 respondents in Europe and in North America had participated in a clinical trial prior to completing the online survey. Respondents diagnosed with an illness represented a broad mix of disease indications.

Higher perceived risk

One out of five people overall considers their general knowledge about clinical research to be poor, but there is wide variation by geographic region. A significantly higher proportion of the public in the Asia-Pacific and South American regions views themselves as less informed, with 28% and 31%, respectively, doing so. But the European public considers themselves to be the least informed, with nearly half (47%) indicating so.

The European public views clinical research as riskier than do their North American counterparts. Approximately one in 10 people in North America believe that clinical research studies are "not at all" and "not very'" safe. This compares with nearly twice that rate (18%) of the European public.

Almost 60% of the public in North America and 53% of those in Europe share the view that the possibility of experiencing side effects is high while participating in a clinical study. A much larger proportion (27%) of the European public believes that study participation poses risks to one's overall health compared to approximately 20% of the public in each of the other global regions assessed.

General public willingness to participate in a clinical research study is consistent with that seen in past global surveys. At this time, a very high proportion (87%) of the public says that it is "somewhat willing" and "very willing" to participate in a clinical research study. The European public shows the lowest level of willingness to participate, with only 58% indicating so in 2013. This compares with 66% of the South American, 73% of the Asia-Pacific, and 90% of the North American public. A lower proportion of the public in Europe is willing to participate in clinical research today than did so in 2007 (71%).

Harder informed consent, lower satisfaction

Among all respondents, one-out-of-five study participants consider the informed consent form to be "somewhat difficult" or "very difficult" to understand. But wide differences are observed by global region: a much higher proportion in Europe-four out of 10 study participants or twice the overall rate-found the informed consent form difficult to understand. In this one regard, study volunteers in South America and Asia-Pacific had the hardest time understanding the informed consent form, with 63% and 69%, respectively, rating their informed consent forms "somewhat" and "very difficult."

Overall, nearly 60% of study volunteers report taking time to read the informed consent form by themselves. A significantly lower percentage of study volunteers outside North America-30% of South American, 46% of European, and 23% of Asia-Pacific-report doing so. Approximately one in four study volunteers read the informed consent form with study staff; the highest percentage (50%) reviews the form with study coordinators. 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).

Among all survey respondents, 85% of study participants 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 European study volunteers is not satisfied that their questions were answered during the informed consent review process.

Lastly, in the aggregate, the overwhelming majority (95%) of study volunteers say that they would consider participating in another clinical research study in the future. The percentage willing to participate has increased by 10% since 2007. But a significantly lower proportion of European study volunteers (80%) share the sentiment. Having been through the clinical trial participation experience, compared with those in other global regions, European study volunteers are among the least likely to participate in another study in the future.

A targeted response

These results, and many more found in the 2013 CISCRP "Perceptions & Insights Study," indicate that there is an urgent need and a major opportunity to educate and engage the European public, patient, and study volunteer communities. There are unique cultural and societal factors contributing to these conditions in Europe. Broad exposure to highly visible and tragic patient deaths in Europe associated with clinical research studies in the not-so-distant-past, and the aftermath of these events, have shaped public attitudes and perceptions.

For a variety of reasons, European public attitudes and perceptions have not rebounded during the past seven to 10 years as have those among the North American public. This may be a function of more frequent and active public outreach and education in North America. Clinical research professional awareness of-and the desire to execute-practices and initiatives that enhance study volunteer experience and establish higher levels of engagement may be relatively lower in Europe at this time.

The efforts of The European Patients' Academy on Therapeutic Innovation (EUPATI)-a consortium funded by the Innovative Medicines Initiative-are much needed to help address the educational disparities among patients and study volunteers in Europe. CISCRP has also turned its sights on the European community with a planned launch of its AWARE-for-ALL public awareness and outreach live event in London in spring 2015. CISCRP hopes to spread its programs and initiatives across all of Europe during the next several years. The European Medicines Agency's (EMA) commitment to improve disclosure and transparency-most notably the distribution of lay language risk-management plans and clinical trial results summaries-will help improve public trust and position Europe as the global leader on this front.

CISCRP hopes to assist the clinical research enterprise in monitoring trends and identifying opportunities to better inform and engage the public and patients as stakeholders and partners. In early 2015, CISCRP will be launching its second "Perceptions & Insights Study," with an eye toward increasing the number of respondents from Europe and other parts of the world.

Kenneth A. Getz MBA, is the Director of Sponsored Research at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, e-mail: kenneth.getz@tufts.edu