Testing new drugs is a costly and frustrating headache for pharmaceuticals companies—and the pain is about to get worse. Clinical trials are at best difficult to manage and dogged by delays, and now the genomics revolution and stricter regulatory standards are compounding the problems. For pharma companies, managing the newly increased demands of clinical trials may become the greatest obstacle to realizing the full benefit of the new health technologies.

Not surprisingly, it is the clinical aspects of these trials that pharma companies concentrate on: making sure that the research methodology or protocol leads to results capable of standing up to the scrutiny of authorities such as the US Food and Drug Administration (FDA). But another crucial element—the recruitment of patients—is often overlooked, causing expensive delays that can drain much of the sales potential from any new drug. More than half of all US clinical trials from 1993 to 1998 missed their deadlines by at least a month (Exhibit 1). A failure to get enough patients in time accounts for 85 to 95 percent of all days lost during clinical trials (Exhibit 2).