Articles
The Value of Postmarketing Studies
By Timothy Pratt, PhD
Originally published in PharmaVOICE, April 2006
Why Physicians Participate
All products require post approval marketing; and if marketing is all about meeting the customers' needs, then that's a great place to start, Dr. Pratt says.
"I suggest that physicians, for the most part, want to do research, and in marketing speak, a want is an unmet need," he says. "Pharma companies know that physicians love to do research on new drugs. Just consider the burden of work when all the requests for funding investigator-initiated trials come flooding in after every new drug is released. Sometimes, if the company won't fund the research, physicians find a way to do it themselves."
This, he says, begs questions beyond the characteristics of the actual product: what are the drivers for physicians to engage in research, and why is it such a big deal?
"It's a big deal because, in conducting research physicians get kudos - from their peers, from their referral base, and from their patients," he says.
Acclaim can come in many forms: publication in medical journals, speaking at dinners/symposia, even in-clinic promotion. In the highly competitive medical-care arena, many physicians believe it is important to be able to assure patients and referral physicians alike that they are staying current in their chosen fields and indeed continually are searching for the best ways to effect the best patient care. Active participation in ongoing research is considered to be an effective mechanism to give such assurance.
"It has been my experience that many physicians who participate in research choose to frame and display manuscripts and abstracts of their work in their clinics," he says. "It is frequently a topic of discussion at referral dinners where they market their services to their customers, the referring physicians; this is vital to their ongoing successful practice. Indeed, I also have seen the newsletters supporting current research placed in patient waiting areas, especially when the clinic is 'profiled' as the site of the month."
For academic institution physicians, engagement in research may actually be a requirement of their ongoing employment. These physicians are not subject to a large degree of referral pressures but are required to publish a certain amount of original research every year. "Publish or perish" takes on a whole new meaning when they need something to publish from (i.e., research). Beyond National Institutes of Health grants or endowments, the primary mechanism to effect the conduct and publication of large-scale original research is corporate sponsorship.
Varying factors - from the use of sophisticated Bayesian statistical models driving down sample sizes, to the conduct of studies outside the United States as a regulatory strategy, to individual rep/MSLs lobbying for their physicians' involvement - may conspire to limit opportunities for physicians to participate in approval studies and engage in research.
"When focus centers are also thrown into the mix, the likelihood of involving the physician from rural Idaho, irrespective of skills or background, is low," he says. "Generally speaking, so much rides on product approval, from a corporate perspective, that few if any risks are willing to be taken. That is not without some justification, given the patient benefit and money involved."
This means that participation in the supporting research is often restricted to a small segment of the available physicians.
