Europeans Weigh-in on Clinical Study Participation

The loss of European competitiveness in the pharmaceutical sector has been widely acknowledged.^1,2 The European Union (EU) has begun to address this issue through efforts such as the implementation of EU Directive 2001/20/EC, intended to align the EU with international standards for conducting clinical research and to encourage innovation. For example, the directive opens the door to allowing advertising in patient recruitment efforts for clinical research studies, a technique long in use in North America.

As the EU gears up to attract more sponsors and clinical trials, the spotlight will turn to the pharmaceutical markets' ultimate customer—the patients who volunteer for trials and who use the resulting products. In a first-of-its-kind effort, the 2004 International Will & Why Survey was designed and deployed in May 2004 to gauge the perceptions and attitudes of Europeans toward participating in clinical research.³ The survey was conducted online between May 17 and May 20, 2004 in six EU countries: the Czech Republic, France, Germany, Poland, Spain, and the United Kingdom. The total number of survey respondents was 2339 (1143 men; 1196 women; see Table 1 for a detailed breakdown).

Table 1. Number of respondents by country

Overview of survey findings

An analysis of all respondents in the aggregate revealed that 68 percent would be willing to participate in a clinical study. However, only 6 to 7 percent of respondents indicated they had participated in a clinical trial (see Figure 1). Of these, 89 percent indicated they would do it again (see Figure 2).

Figure 1. Willingness to participate in a clinical study.

Of all the respondents surveyed, 71 percent 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 (see Figure 3).

Figure 2. Satisfaction with clinical study experience.

Over 1490 individuals who had not yet participated in a clinical research study but who said they would consider it were asked about their reasons for being willing to enroll. Of these respondents, 69 percent indicated "To advance medicine/science." "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. (See Table 2 for the complete list of possible answers.)

Table 2. Reasons for participating in a clinical study (multiple answers possible)

Czech Republic

Of the Czech respondents who had never participated in a clinical trial, 24 percent would consider participating in a clinical trial and 76 percent would not. Of the Czech respondents who would participate in a clinical trial, the reasons given were as follows: 25 percent indicated altruism (advancement of medicine/science and to help others with the condition), 10 percent indicated they had no other treatment options, and 9 percent indicated they wanted to earn extra money. Of the Czech respondents who would not participate in a clinical trial, 37 percent responded because of the health risks in clinical trials and 21 percent responded because of the "guinea pig" perception associated with clinical trials.

Figure 3. Understanding the impact of international patient protections.

France

Of the French respondents who had never participated in a clinical trial, 71 percent said they would consider participating in a clinical trial and 29 percent would not. Of the French respondents who would participate in a clinical trial, the reasons given were as follows: 38 percent indicated altruism (advancement of medicine/science and to help others with the condition), 14 percent indicated they wanted to earn extra money, and 8 percent indicated it would be to obtain access to the latest medical advancements. Of the French respondents who would not participate in a clinical trial, 51 percent indicated the health risks in clinical trials and 21 percent indicated the "guinea pig" perception associated with clinical trials.

Germany

Of the German respondents who had never participated in a clinical trial, 79 percent said they would consider participating in a clinical trial and 21 percent would not. Of the German respondents who would participate in a clinical trial, the reasons given were as follows: 25 percent indicated altruism (advancement of medicine/science and to help others with the condition), 14 percent indicated they wanted to earn extra money, and 13 percent indicated it would be to obtain better treatment for their condition. Of the German respondents who would not participate in a clinical trial, 40 percent responded because of the health risks in clinical trials and 32 percent responded because of the "guinea pig" perception associated with clinical trials.

Figure 4. Percent of respondents who would consider participating in a clinical trial.

Poland

Of the Polish respondents who had never participated in a clinical trial, 74 percent would consider participating in a clinical trial and 26 percent would not. Of the Polish respondents who would participate in a clinical trial, the reasons given were as follows: 18 percent indicated altruism (advancement of medicine/science and to help others with the condition), 9 percent indicated it would be to obtain better treatment for their condition, and 9 percent indicated they would if they had a life-threatening illness. Of the Polish respondents who would not participate in a clinical trial, 45 percent responded because of the health risks in clinical trials and 28 percent responded because of the "guinea pig" perception associated with clinical trials.

Spain

Of the Spanish respondents who had never participated in a clinical trial, 75 percent would consider participating in a clinical trial and 25 percent would not. Of the Spanish respondents who would participate in a clinical trial, the reasons given were as follows: 21 percent indicated altruism (advancement of medicine/science and to help others with the condition), 10 percent indicated they wanted to earn extra money, and 9 percent indicated they would participate if their doctor recommended participation. Of the Spanish respondents who would not participate in a clinical trial, 53 percent responded because of the health risks in clinical trials and 25 percent responded because of the "guinea pig" perception associated with clinical trials.

United Kingdom

Of the British respondents who had never participated in a clinical trial, 86 percent would consider participating in a clinical trial and 14 percent would not. Of the British respondents who would participate in a clinical trial, the reasons given were as follows: 25 percent indicated altruism (advancement of medicine/science and to help others with the condition), 12 percent indicated they wanted to earn extra money, and 10 percent indicated it would be to obtain better treatment for their condition. Of the British respondents who would not participate in a clinical trial, 49 percent responded because of the health risks in clinical trials and 24 percent responded because of the "guinea pig" perception associated with clinical trials.

Implications

Since participation in clinical trials is low, even with an individual satisfactory experience, and willingness to participate is high, there may be a substantial gap in communication. Actual participation may be hindered by low awareness and/or misconceptions about clinical studies. As the survey suggests, providing information about patient protections increases public willingness to consider participation. The findings of the survey therefore indicate a connection between the level of public awareness of clinical research efforts—with their built-in safeguards—and patient willingness to enroll in clinical trials.

For sponsors expanding clinical trials into the global marketplace, it is interesting to note that respondents' interest in and reasons for participating in clinical trials were remarkably similar in all of the countries surveyed, with the exception of the Czech Republic. The benefits of the Czech health care system may help to explain the lower percentage of people willing to consider trial participation. For example, Czech 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 an average of seven annual visits in the EU). Frequent contact with health care providers may make Czechs feel less impelled to consider the option of clinical studies.

In Europe, like many other places in the world, most information reaches patients through health care providers or through disease awareness campaigns. Most spending on promotional materials remains largely targeted to physicians. The lack of direct-to-patient communications via television, radio, and Internet advertising, which are either not permissible or not routinely utilized in all polled countries (United Kingdom, France, Germany, Spain, Poland, and the Czech Republic), presents barriers to helping people understand both the role of clinical research and the potential benefits of participating. 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. Investing energy into public education about the measures in place to protect participants in clinical studies could have a significant influence on both willingness and actual participation.

Looking ahead

The 2004 International Will & Why Survey results present sponsor companies with compelling arguments for expanding patient education efforts. This can be achieved on many fronts in the EU, including promoting an environment with easier access to direct-to-consumer information, maximizing the new regulatory environment, and leveraging communications to patients for clinical study recruitment. By expanding communication channels and making existing information more robust, sponsors can interest, attract, and educate potential study participants and contribute to building strong public support for the clinical research enterprise as a whole.

Globally, there are still many legislative barriers to full and open communications to consumers and patients. Only the United States and New Zealand currently allow widespread direct-to-consumer (DTC) information.⁴ But there is evidence that the trend is shifting. EU countries are discovering that as Internet use spreads, the pressure from consumers for more information increases. This pressure is likely to grow as Internet use spreads in developing nations as well. Internet access removes national barriers to information. Online information generated by companies for U.S. consumers will become instantly available around the world and legislative restrictions to Internet information will become moot.

In addition, one goal for the recent implementation of EU Directive 2001/20/EC⁵ is to establish parity with the United States so that Europe can attract more clinical trials and a larger share of the resources, jobs, and opportunities that come with them. By the simple act of mentioning advertising, the directive opens the door to reaching out directly to patients with information about clinical research. While it may be years before all EU member nations bring their national legislation in line with the directive and truly reach parity with the United States, the likelihood is that Europe will see a more open and competitive marketplace where countries seek to attract sponsors of research, using marketing communications as a tool for recruiting patients and enhancing participation.

Sponsors conducting research in the EU can take advantage of this environment and apply lessons learned in the field of patient recruitment in the United States. There, patient recruitment is a growing industry with many pharmaceutical sponsors now outsourcing their recruitment efforts to marketing experts. These experts have broadened the definition of "advertising" to direct-to-patient communications, including a wide range of tactics for reaching patients—from mass media outreach to site-level communications—many of which can be implemented in EU countries. Comprehensive recruitment kits including media advertisements, an assortment of printed materials (i.e., brochures, physician letters, patient appointment books, event flyers, etc.), Web sites, and email information can be used to alert and educate potential participants to the study opportunity and help them make informed decisions about participation.

The global marketplace offers sponsor companies widespread opportunities. As sponsors expand their clinical trial efforts globally, they are likely to see the marketplace change with developing nations competing for the resources, jobs, and opportunities that come with research studies. With so many countries in Eastern Europe, Latin America, and Asia now offering similar environments (large populations of treatment-naïve patients, low operating costs, and improving infrastructures), those sponsors who leap ahead of their competitors in providing more thorough and widespread patient information are likely to gain and retain a distinct competitive advantage.

Bonnie A. Brescia is founding principal of BBK Healthcare, Inc., 320 Needham St., Newton, MA 02464, (617) 630-5505, fax (617) 630-5090, email: bbrescia@bbkhealthcare.com www.bbkhealthcare.com.

References

1. "The Pharmaceutical Industry in Figures, 2004 Edition," European Federation of Pharmaceutical Industries and Associations, 2004.

2. "G10 Medicines High Level Group on Innovation and Provision of Medicines Consultation Paper," European Federation of Pharmaceutical Industries and Associations, 2001.

3. BBK Healthcare, Inc., "The 2004 International Will & Why Survey. Internet poll of >2,300 patients," June 2004.

4. "Direct-to-Consumer Advertising of Prescription Medicines in New Zealand: A Discussion Paper," Ministry of Health, New Zealand, November, 2000.

5. "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use," Official Journal of the European Communities, 1 May 2001.