Culture Clubs: Independent Ethics Committees - Pharmaceutical Executive

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Culture Clubs: Independent Ethics Committees
Independent ethics committees sign off on patient-recruiting strategies around the world. Think laws and regulations shape their decisions? Think again. A new study shows that ethics committees are


Pharmaceutical Executive


A Question of Semantics and Perception



It may be that the word "advertising" elicits confusing responses from ethics committee members. The term itself, which could bring ideas like "coercion" and "selling" to mind, has different connotations for different people. Some reject it entirely. For others, individual media may provoke strong feelings and preferences. Take direct mail, for example. In Finland, for example, ethics committee members say that sending a postcard to inform a person about a clinical trial for diabetes is too intrusive, since it informs recipients that researchers know they have diabetes. In Slovenia, on the other hand, direct mail is considered a discreet and acceptable approach. Some may think of TV as benign and all encompassing, while others may view it as too coercive—indeed, the most coercive medium. And in countries where radio is historically a public, commercial-free medium, radio advertising of any sort is still new, which may slow the acceptance of radio recruitment ads.

In BBK's survey, some respondents who indicated they believe advertising is permitted stopped short when asked to select specific vehicles—perhaps another indication of general confusion on the subject.

Also confusing the matter: In the EU, advertising for reimbursable medicinal products is banned by law, so ethics committee members may be unwittingly extending these laws to patient-recruitment advertising—unnecessarily forfeiting the benefits these tactics could provide, like enrolling studies faster and speeding up time-to-market for new treatments.

In the European Union Directive (2001/20/EC)—the legislation intended to align the EU with international standards for conducting clinical research and to encourage innovation—Article 8 uses the word "advertising" to refer to patient recruitment. It explicitly acknowledges the role of direct-to-patient outreach and education in furthering clinical research and development.

This fact alone should inform ethics committee members that the EU is broadening the definition of advertising for patient-recruitment purposes to include ethical, non-coercive campaigns focused on awareness and education. However, respondents to BBK's survey, when asked about the impact of the Directive on direct-to-patient outreach, appeared to be noncommittal. Most said that they had "not considered" its implications—an indication that the process of adopting and integrating these standards throughout the clinical research community is a slow one, especially if sponsor companies do not push the issues.

Other Patient-Outreach Communications

Another series of survey questions asked ethics committee members to respond to additional patient-recruitment communications, including publicity (press kits), site-based outreach materials, and retention materials, such as low-cost health-oriented items for patient recognition.

Again, ethics committees disagree about which communications tactics are allowed by law. The vast majority of ethics committee respondents who indicated that a particular tactic was not permitted also said they knew of no law that prohibited the use of that tactic. And many ethics committee members who called tactics permissible appeared to base their responses not on an awareness of specific regulatory guidelines, but on the fact that they had seen them used before. As was the case with advertising, convention, precedent, and personal choice seem to have a greater impact on committee decisions than regulatory stipulations.


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