This is a great article from the Wall Street Journal about a new approach to clinical trials called “adaptive design.”  It allows researchers to look at study results much earlier in the process, enabling researchers to steer later-enrolling patients into studies where they may receive the most medical benefit based on the genetic profile of their disease.  It’s a more personalized version of clinical research, which, as it expands, will have a positive effect on the image of clinical trials among prospective patients.

Earlier this year, a good friend of mine had appendicitis.  During his time in the emergency room, he received a CAT scan, which confirmed the diagnosis, and he went into surgery.

The day he checked out of the hospital, his doctor came by.  While the appendectomy had gone well and my friend was healing well, the doctor had additional news – in addition to the appendicitis, the CAT scan had also revealed a spot on one of his kidneys.  Was it a tumor?  The doctor recommended he follow-up on it and referred him to another doctor.

In a recent article (and follow-up editorial) in the Archives of Internal Medicine, found here, the question was raised whether medical research participants should be notified of “incidental findings” that turn up on radiological reports but are unrelated to the research study’s intent.  Say you’re in a heart study and a chest scan (as required by the study’s protocol) indicates a spot on one of your lungs.  The debate was whether you should be told about the lung finding.  Maybe the person reading the radiology results isn’t really qualified to interpret them beyond the study parameters.  Or perhaps it’s a false-positive that will give you unneeded stress and require many other tests, which come with their own risks to you.  So, should you be told?

Are you kidding me?

One of the hesitations that people have about participating in clinical trials is the perception that the research is not really interested in the patient’s health, but rather in getting the data about the investigational medicine.  This is largely untrue.  But even to question the true motive hints that perception might sometimes be reality in this case.

While the primary purpose of medical research is gaining information about the investigational treatment, patients should feel (and truly realize) that they are getting the highest level of medical care by volunteering.  To suggest otherwise only undermines efforts to get more people to participate in medical research.  There should be no dilemma here – the patient should be told of the findings and provided resources for follow-up.  That extra bit of health security will only enhance the medical research experience in the eyes of the public.

As for my friend, thank goodness the doctor did say something.  It was a tumor on his kidney, necessitating more surgery.  Because of the appendicitis (it could have just as easily been an incidental finding in a clinical trial test), the tumor was caught early and my friend is now making a full recovery.

http://www.nytimes.com/2010/08/18/sports/18gehrig.html

Here is an interesting article from today’s New York Times.  It just further demonstrates that through continued research comes new discoveries which could end up leading to more efficient treatment options in the future.

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.

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:  http://www.therxclub.com/rx_current.php

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.

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.

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm

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?