Monday, October 31, 1994
Land mine checklist
As the descriptions of trials run by three companies demonstrated in last week's Commentary, the devil truly resides in the details of clinical trial planning and management. And despite the most rigorous plan, in many instances the unexpected discovery may provide a fortuitous insight that points to a more successful outcome, or just as easily lead to a disappointing conclusion.
Clearly, the chances for 100 percent foresight in planning a trial are vanishingly slim. Nevertheless, managing risk in the clinic is a prospective endeavor, and failures often can be blamed on the lack of sharp planning and anticipation before a patient is ever enrolled.