WASHINGTON, June 10 /PRNewswire/ -- Forty-two percent of Europeans surveyed would be more likely to participate in a clinical research study if they were aware of the measures in place to protect them. These findings come from more than 2,300 men and women who responded to "The 2004 International Will & Why Survey," a BBK Healthcare, Inc., initiative to determine Europeans' motivations to participate in clinical research studies. The Czech Republic, France, Germany, Poland, Spain, and the United Kingdom were represented in this landmark effort to gauge international perspectives. The findings provide insight into the rapidly growing enterprise of global clinical research and identify opportunities for increasing public awareness about the value of participation. Survey results will be made available at the 40th Annual Drug Information Association (DIA) Meeting in Washington, D.C., June 13-17, 2004.
The need for increased education is clear. Seventy-one percent of individuals surveyed indicated they were not aware of patient protections such as the Declaration of Helsinki, ethics committees, and the informed consent process. However, after these protection measures were described, 42 percent said they would be more likely to participate in a clinical research study. These responses are consistent with the 2001 "Will & Why Survey," in which 40 percent of Americans surveyed said they would be more likely to participate if they were informed of the protective measures.
"In comparing the results from American and European surveys, there were striking similarities. These similarities originate from a universal truth that is particular to healthcare, which is much different from any other consumer product: regardless of what country you live in, if you are sick, you want to get better," says Joan F. Bachenheimer, founding principal of BBK Healthcare, Inc.
Sixty-eight percent of individuals polled in "The 2004 International Will & Why Survey" said they would consider participating in a clinical study. When asked to indicate the reasons why, the majority of respondents (69 percent) said "to advance medicine/science." These findings come from more than 1,490 individuals who said they have not yet participated in a clinical research study but would consider participating. "Earning extra money" was the second most influential factor (58 percent); "To help others with the condition" was third (57 percent); "To obtain better treatment for my condition" was fourth (48 percent); and "To obtain faster access to treatment for my condition" (34 percent) was fifth.
The survey results have an added bearing as an increasing number of clinical trial sponsors are expanding their efforts overseas. In 1980, just 41 foreign clinical investigators conducted drug research under an investigational new drug application (IND). By 1990, that number grew to 271, and by 1999, to 4,458 (Office of Inspector General). Central and Eastern European countries have become increasingly popular for clinical research, and the interest continues to push eastward toward Poland, Hungary, and the Czech Republic. Lower costs, access to motivated investigators and treatment-naE[macron]ve patients, and patients concentrated in large public hospitals are some of the key attractions (CenterWatch 2004).
Despite the rise in clinical studies conducted in Europe, only five percent of respondents indicated they had participated in one, compared to 13 percent of Americans who responded in the 2001 "Will & Why Survey." In Europe, participation is hindered by low awareness and misconceptions about clinical studies. The lack of direct-to-patient communications, such as television, radio, and Internet advertising, which are not permissible or routinely utilized in all polled countries, presents a barrier not seen in the United States. Furthermore, respondents' considerable concerns "about the health risks of clinical research studies" and "[being] treated like a 'guinea pig,'" reinforce the need for improved education.
For those who have participated, the experience seems to be positive, since 89 percent said they would do it again. "But access is so limited, eventually this pool will be exhausted," comments Matthew Kibby, leader of BBK's metrics and evaluation team. "It is crucial that we begin laying the groundwork for public understanding of clinical studies in order to ensure future participation," continues Kibby.
The Czech Republic offered the most dramatic differences in responses to the survey. Of those surveyed, only 24 percent said they would consider participating in a clinical study. This compares with 71 percent in France; 79 percent in Germany; 74 percent in Poland; 75 percent in Spain; and 86 percent in the UK. While this low number indicates opportunities for education, it also highlights challenges posed by the Czech healthcare structure. For example, patients are not responsible for co-payments at the point of service and can obtain the full range of drug therapy with no out-of-pocket payments. On average, Czechs visit the doctor 14 times per year (compared with seven average annual visits in the EU). "From these results, it is clear that there is a limited incentive to participate in clinical research studies in the Czech Republic," comments Bachenheimer.
The recent implementation of the European Union Directive is intended to further streamline clinical research efforts. It requires all 25 member states of the EU to transfer Good Clinical Practice requirements from guidance into law. However, additional steps are needed. In 2002, BBK launched Good Recruitment Practice(SM) to create a new industry standard for optimizing the patient and investigator recruitment process. During the coming year, this group will explore methods for promoting protections overseas.
Founded in 1983, BBK Healthcare, Inc., is a marketing consulting firm for the clinical R&D segment of the pharmaceutical, biotechnology, and medical device industries, helping to accelerate time to market for new medicines and treatments. BBK has successfully supported hundreds of clinical studies, from Phase I through IV and other late-phase trials, in all major therapeutic areas. As thought leaders, BBK continually contributes ideas that accelerate and improve the clinical development cycle, such as Good Recruitment Practice, TrialCentralNet(SM), and most recently redefining patient recruitment as the discipline of study relations. BBK offers global services in recruitment feasibility, patient enrollment, investigator selection, pediatric trials, retention, and more. For information, please visit http://www.bbkhealthcare.com/.
Editor's Note: Press materials about "The 2004 International Will & Why Survey" will be made available in conjunction with the DIA meeting in Washington, D.C., June 13-17, 2004. Materials will be in the DIA press room and BBK Healthcare's booth (921).
CONTACT: Elizabeth Gargill, +1-617-630-5513, egargill@bbkhealthcare.com, or Linda Wolf, +1-617-630-5523, lwolf@bbkhealthcare.com, both of BBK Healthcare, Inc.
Web site: http://www.bbkhealthcare.com/
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