European patient engagement in critical condition
Western Europe boasts one of the largest and most active markets for clinical trials. Indeed, more than one in five active clinical investigators is based in Western Europe, and the growth in sponsor spending there now outpaces that in the U.S.
Despite research professional optimism and a vibrant clinical trials market in Western Europe, however, the European public considers clinical research to be riskier than does the public in many other global regions, and 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.
As sponsors and CROs look for new opportunities to engage patients and the public, Western Europe represents a critical and urgent place to focus attention.
A 2013 study conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) presents data characterizing this disturbing picture. The online study is based on nearly 6,000 responses from different global regions, with 75% of respondents residing in North America, 15% based in Europe, 5% from South America and another 5% from Asia-Pacific.
Among the findings:
- While 28% of the public surveyed in the Asia-Pacific region and 31% in South America viewed themselves as less informed about clinical research, nearly half (47%) of the European public surveyed considered themselves to be the least informed.
- A significant portion (27%) of the European public shared the view that they could experience side effects while participating in a clinical study, compared to about 20% each in North America, Asia-Pacific and South America.
- About 90% of the general public in North America was either “somewhat willing” or “very willing” to participate in a clinical trial, while only 58% of the public in Europe was willing, according to CISCRP.
Low awareness and access
Research professionals based in Europe provide a number of explanations for the negative public and patient attitudes and perceptions.
“Overall, there is not a huge awareness of clinical trials and how they work compared to the U.S.,” said Martin Robinson, Ph.D., executive vice president of IAOCR, a provider of competence-based accreditation, consultancy and accredited training for professionals within the clinical research sector.
“With a few exceptions, such as the United Kingdom, patients in Europe might not have sufficient experience in knowing about clinical trials—which has to be improved to change some perceptions,” said Nikolay Grechko, M.D., a medical monitor who has worked for clinical trials and recently co-authored a study on the challenges of clinical site monitoring in Eastern Europe. “Also, clinical trials are not as popular in Western Europe as they are in Central and Eastern Europe.”
Grechko added that in some European countries, participation in clinical trials gives patients an opportunity to obtain not only an experimental drug, but also the drug that is administered as a standard-of-care in Western Europe and is used as a comparator in clinical trials that is paid by sponsors.
Some observers say attitudes toward clinical trials stem from the lack of information about clinical research in the mass media. Germany, Italy and Spain have limitations on advertising clinical trials to attract participants, compared to the U.K., Netherlands and Belgium. Most European countries have not supported public awareness campaigns.
Government medical insurance in Western Europe is very basic and clinical trial participation is not covered. And in Western European countries, the initial stages of investigator identification, selection and recruitment often are automated and no contact is made with any potential patient until the PIs’ online questionnaires are analyzed.
“Overall, Western Europe doesn’t do as much early patient research as parts of Eastern Europe and the U.S. do, where it is easier to search for, with a few exceptions like the U.K., as there is less clinical trial awareness in many Western European countries,” said Lindy Jones, Quintiles’ senior vice president and global head, Therapeutic Science and Strategy Unit.
In some Western European countries, trial participants and the public do not have support from their healthcare providers, making access to clinical trials more difficult. To gain insights into cancer patients’ attitudes toward clinical research based on their own experience, a recent study entitled “Exploratory Research into Cancer Patients’ Attitudes to Clinical Trials” was conducted in six countries (the U.S., U.K., Germany, France, Italy and Japan) and involved 48 cancer patients. The majority (73%) did not recall discussing clinical trial participation with their doctors, which was slightly lower than an earlier survey of 6,000 cancer patients that found 80% were unaware that clinical trial enrollment was a treatment option.
“Not only was awareness of clinical trials low among the cancer patients, but—when during the course of this study the concept of clinical trials was raised—most respondents tended to believe that if participation was suitable or best for them, their doctors would have discussed it with them,” according to the survey. The survey results were published last year in ecancermedicalscience, an open-access cancer journal from the European Institute of Oncology.
The report also includes the actual comments from participants who expressed a range of attitudes toward clinical trials. Among them:
- “I think they are for when all hope is gone and there is no other alternative,” said a French cancer patient. “The patients who participate in a trial really have no choice.”
- “The hope that there is a new medication in which my husband and patients in general can participate,” said a German caregiver and respondent. “Your hopes are that the cancer will be stopped, that research can possibly manage to find something with which this disease will be treated. You think about hope rather than risks and side effects.”
Steps to improve
Fortunately, signs of positive change to address low European public and patient awareness are beginning to appear.
The efforts of The European Patients’ Academy on Therapeutic Innovation (EUPATI)—a consortium funded by the Innovative Medicines Initiative—are helping to address the educational disparities among patients and study volunteers in Europe. EUPATI has been holding patient education programs and intensive training of patient ambassadors.
CISCRP also has 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 2016. CISCRP hopes to spread its programs and initiatives across all of Europe during the next several years. The AWARE-for-All programs typically attract 500 patients and nearly 100 research and health professionals.
The EMA’s commitment to improve disclosure and transparency—most notably the distribution of lay language risk-management plans and clinical trial results summaries—may also help improve public trust and position Europe as the global leader on this front.
In an effort to bring attention to clinical trials, Holland has developed a leaflet on the importance of clinical trials, which is available in Dutch and English. It explains how trials work and includes questions potential participants should consider.
“It goes over why a clinical trial is valuable, why your participation is important,” said Vivienne van de Walle, M.D., a former PI and clinical site director who is now a clinical trials consultant in Maastricht, Netherlands. “Holland has come a long way, as we can use social media, and I even had a trial where a movie was used for informed consent.”
The U.K., through its National Institute of Health Research (NIHR) Clinical Research Network, recently launched a significant effort to publicize available clinical trials in all its research hospitals. The organization enabled seniors recruited into trials to receive free bus travel to trial sites after the morning rush hour. The network also began working with patient advocacy groups and advocating for more flexible hours for site appointments.
Last year, more than 600,000 patients took part in clinical research studies supported by the network. With its goal to raise the profile of clinical research, NIHR is advocating that nearly everyone has a role in clinical research, including healthy people for early-phase studies.
“Our network has led the transformation of the clinical research landscape,” said network CEO Jonathan Sheffield. “Our problem is less about finding patients and more about how the nature of clinical trials is changing. We want to see more patients get involved in all stages of research and development and design. We have a clear policy of getting many people involved. We need to have more doctors involved in clinical trials, although some say it is not their responsibility. We now have e-consent [ethical consent akin to IRB], but more important is that trial participants are properly informed, understand the research and the value of their research. For me, it is most important that research is visible.”
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
This article was reprinted from Volume 22, Issue 10, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>