Marketing's impact in the clinic
Companies may face their first critical marketing decisions when it becomes time to enter the clinic. This week, BioCentury talks to company managers and analysts about diseases where marketing issues play an important role in clinical decisions. Next week, BioCentury will present a case study of three competitors whose marketing approaches are reflected in their clinical trial plans.

First of two parts

Since early 1991, Centocor Inc. has been quietly conducting clinical trials of its HA-1A sepsis drug in fulminant meningococcemia in patients 18 years and younger.

In contrast to adult patients with other types of sepsis, these patients tend to have a higher incidence of gram-negative bacteremia while not having additional underlying diseases that might confound clinical data. As a result, the company said last week, "the effect of HA-1A on mortality in the meningococcemia indication might be more clearly measured than its effect in other indications studied to date."

In the 1980s, CNTO made a strategic decision to go after the broadest possible label for the drug. Given the difficulties in sorting out efficacy data from the heterogeneous patient populations tested by would-be sepsis drug makers, one wonders what might have been if CNTO (or Xoma Corp., or Synergen Inc.) had gone after a narrow indication first.

Broad vs. narrow

CNTO isn't alone in facing such dilemmas. Every time a company designs a clinical trial, it is making fundamental marketing decisions. At its most basic, the choice is between going after the greatest return from the broadest indication possible and making a surer bet on a narrower label (if there's such a thing as a sure bet in drug development). The decision has implications for the speed with which a product gets to market and the competition a drug will face when it gets there.