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 email@example.com