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qd Solutions Blog
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Hoping for “hope”

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,Clinical Trials,IRB
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Could the FDA’s “Bad Ad” program be coming to a patient recruitment campaign near you?

Recently the U.S. Food and Drug Administration (FDA) announced the “Bad Ad Program,” an effort to have doctors and healthcare professionals around the country report what they believe to be misleading drug ads.

Evidently, the initiative is to help the FDA’s understaffed and overwhelmed Division of Drug Marketing, Advertising and Communications (DDMAC) with more surveillance of the large volume of direct-to-consumer (DTC) promotional materials that makes its way to consumers and medical personnel every day. The measure has been largely panned in the drug advertising community as too broad, lacking in education, and questions its ability to overcome biased reporting from doctors who are already anti-DTC.

While “bad ads” do seem to be the stated battle, it appears the real concern is the way drugs are marketed that the FDA can’t see (i.e. detailing by reps to doctors behind closed doors, comments made at medical conferences, etc.) where false claims, overstated results, off-label promotion, and understated risks can be made.

Within the patient recruitment industry, there are Institutional Review Boards (IRBs), per FDA regulations, to review and approve promotional recruitment materials. However, with dozens of IRBs reviewing patient-facing recruitment materials, experience suggests that while some IRBs won’t approve certain language in recruitment materials, others will approve it with no changes. Those inconsistencies invite complaints and governmental review. Being a part of this industry for more than 14 years, I’ve seen recruitment materials overly promote the monetary benefits of study participation (i.e. visuals of dollar signs) and make promissory statements about the investigational treatment.

No doubt the vast majority of pharmaceutical DTC marketing is done within FDA requirements. Like most things in life, though, a couple of bad apples ruin it for everyone else trying to gain some false competitive edge. The same could certainly occur in the patient recruitment industry, where competition for medical research study patients can be fierce. All it takes is one ill-timed, unethical, unapproved (and arguably uneducated) recruitment ad to generate complaints that invite government scrutiny. Without a consistently high level of self-policing among patient recruitment agencies and sites, the industry may find itself also under the interrogation spotlight.

Posted by qd_admin on June 23rd, 2010 :: Filed under Advertising,Clinical Trials,FDA,IRB
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