Branding clinical trials -- promise doesn't mean bravado

Amid the torrent of media attention to failed drugs, mislabeled drugs, and drugs that do not do what they say they do, there are increasingly calls for more clinical proof. Everyone from insurance companies to doctors, from medical journals to patients -- they all want to know they are getting what they are bargaining for.

So, the pharmaceutical industry is responding with more new trials that attempt to make the case for their products.

Two recent head-to-head trials are apropos for discussion: Bristol-Myers Squibb’s PROVE-IT trial in 2003 and Merck/Schering-Plough Pharmaceutical’s ENHANCE trial concluded earlier this year. Both are examples of drug-versus-drug comparisons, and both suffered from the same fatal flaw.

The financial danger of a comparison study, of course, is that your drug fails. That is not a position you want to find yourself in. Failure is one thing, but what this brings beyond the immediate consequences is a raft of attention – and not the kind of attention you want.

Both PROVE-IT and ENHANCE set themselves up in a bet-the-farm proposition. Their trial campaigns carried with them extreme overconfidence. While I'm not qualified to comment on the study design, I can critique the brand design. We would never recommend branding a trial, head-to-head or otherwise, with such bravado, arrogance, and potential over-promise.

Read more about both these cases: ENHANCE Trial; PROVE IT Trial