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


Implications

The wildly divergent answers from ethics committee members presents a challenge to multinational patient recruiters, but they open up some intriguing opportunities as well. The good news to take away from BBK's survey is that worldwide regulatory attitudes about tactics and patient outreach in clinical trials may actually be more favorable than most people, including country study managers and ethics committee members, think. The pharmaceutical industry can seize an opportunity to educate the clinical study community—including country study managers and ethics committees—on a broader definition of "advertising," to include building patient awareness about clinical trials.

Because ethics committees rely on cultural assumptions, they are open to cultural change. By firmly but sensitively presenting new patient-recruitment tactics wherever the opportunity emerges, sponsors can speed patient recruitment while keeping it culturally appropriate and within the bounds of ethical standards.

Instead of asking, "Can we use a specific communications tactic?", pharma should ask, "Do we need to use the tactic?" If the answer is "yes," the best bet is to submit the communications materials to the ethics committee, supported by a strong and specific argument. Working closely with the country study manager, global trials managers can choose the most appropriate tactics, without caving in to assumptions and conventions. The only way to expand the boundaries is to push the boundaries, and see what gives way.

As global clinical trials evolve during the next decade, they provide an opportunity for sponsors and sites to continue pushing the boundaries. Researching and respecting cultural and ethical guidelines for each country is vital. But the goal is to challenge those unreliable assumptions and unquestioned precedents that tend to limit patient recruitment. The more recruiters learn about ethics committees, the more opportunity they have to leverage each country's desire to reap the rewards of clinical research, which is the best motive for effecting cultural and regulatory change.

Matthew Kibby is a lead member of the strategic services group at BBK Healthcare, Inc. He can be reached at


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