Guest Column | January 11, 2016

The Achilles Heel of Clinical Study Startup - Bottlenecks

Craig Morgan

By Craig Morgan, NZCS, MBA (Hons), PMP, goBalto, Inc.

The clinical trial phase of a drug development program is by far the most costly, risky, and protracted phase of the investigative process. Over the past decade, the capitalized cost to develop an approved new drug has more than doubled to $2.6B (1), with the approval rate for drugs entering clinical development dropping to less than 12 percent. Though the most recent data released by the FDA indicate that median times to approval have decreased by a few months, the drug development process remains long and arduous. On average, a new drug requires at least ten years to move from initial discovery to market, with clinical trials alone requiring six to seven years (2). Success requires enormous resources at a time when the industry faces increased scrutiny and intense pressure to conduct faster and more cost-effective clinical trials.