I was struck by a recent Applied Clinical Trials article
by Ken Getz about the IRB system and the need for reform. In the article, Ken talks about the rejection of a patient education brochure by an IRB because the word “hope” was used in the document. According to the IRB, it’s coercive.
Unfortunately, it wasn’t a big surprise. As an ad agency that develops patient recruitment materials for CROs and sponsors, we know that words like “hope” are a big no-no with regulators. The belief is if we explicitly say “hope,” then people will make enrollment decisions based on that rather than facts. And yet I’ve seen in focus groups that patients understand that there are no guarantees with medical research. Just to make sure, we say exactly that in our recruitment materials. It’s also why we don’t use the word “cure.”
Still, removing the word from recruitment materials doesn’t make it go away with study participants. Plus the industry, which the regulators are part of, don’t want it to.
Largely, clinical trials are about hope for patients — the hope that the investigational medication does something that’s more positive than their current treatment. And sponsors support this with protocol inclusion criteria that many times require patients to be struggling with or failing their current, approved treatment. For the most part, patients participate in studies specifically to counter what the inclusion criteria ask for.
To assume that by not actually using the word “hope” that patients won’t have it is false. Someday, regulators (along with legal counsel) will be comfortable with the idea that hope is implied whether we say it or not. Rather than hiding the word, we can bring hope out front with our patients, and bask together in it. Recruitment and the drug development process will be better for it.
Posted by qd_admin on January 18th, 2011 :: Filed under Advertising
Tags :: Advertising
, Clinical Trials
, Patient Recruitment
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