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qd Solutions Blog
What’s going on at qd Solutions and rattling around in our brains

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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Patient recruitment advertising takes a creative step forward

Within the vast advertising community, it’s often difficult to convey what we do as an ad agency.  Heck, my father still doesn’t really understand what I do. Our agency doesn’t create funny beer ads, or promote a cool sports line.  We don’t hype banks or help sell food.  And while our clients are in the pharmaceutical industry, we don’t work on approved drugs.  What we do, I think, is far more challenging.

We work 24/7 to develop compelling ad campaigns that recruit the general public into medical research studies.  We must convince people that the future of medicine depends on their participation in a clinical trial with an “investigational medication” that has not been approved by a country’s drug review agency (i.e. the FDA). If that’s wasn’t hard enough, we must be compelling within a legal and regulatory box that most agency-types would find ridiculously-limiting to the creative process.  In pharmaceutical communications world, patient recruitment advertising is not the “coolest” of creative spaces.

So we were humbled and honored last month when we won two prestigious awards at the international Rx Club Show.

Check it out here:

Established to honor worldwide pharmaceutical product advertising and promotion, The Rx Club Show is judged in various categories by a panel of industry experts and is based solely on creativity.

You’ll see that most all of the winners are for campaigns promoting approved medications – that’s generally where the big agencies (and the big budgets) hang-out. By our count, we were the only agency to win based on work in the patient recruitment advertising niche.  Pretty cool for us.  Even better for the patient recruitment industry.

Posted by qd_admin on December 17th, 2009 :: Filed under Advertising,Clinical Trials
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Interesting timing…

Two big developments in the pharmaceutical world of social media.  Here we are today with the first qd blog entry, while at the same time the FDA is holding a hearing on the use of the internet and social media in the promotion of approved medical products.

Since we live in the “pre-approval” medical products space of patient recruitment for clinical trials, we’re all hoping for some guidance that can help us as well.  We’ve heard from focus groups that the public wants quick, easy-to-find information about medical research studies.  The challenge, of course, is how to do that within the confines of IRB approval, where all content targeting potential patients must be approved well in advance.

Study websites are on the rise with sponsors, and are fairly easy to create within the confines of the IRB.  But the instant gratification of social media makes everyone in the clinical trial industry nervous. And yet, social media is not only the new marketing frontier, it provides the constant stream of information that society has come to expect, and arguably, deserves.

If the interest in open communication about clinical research is truly sincere, don’t we owe the public the information they want in a timely manner?  And if the results are stronger participation in clinical research, and thus more effective drugs brought to market more quickly, don’t we all win?

Posted by qd_admin on November 12th, 2009 :: Filed under Clinical Trials,Social Media
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