July 4, 2009

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A Single Phase III Trial - And You're Done?

By BIO-IT World

December 15, 2003 | Carl Peck is director of Georgetown University's Center for Drug Development Science. He spent 26 years in government service, including a stint as director of the FDA's Center for Drug Evaluation and Research (CDER). In the June issue of Clinical Pharmacology & Therapeutics, Peck proposed that by using biomarkers and other technologies, including simulation, just a single clinical trial might be necessary for FDA approval.

Q: What has the response been to your proposal?
A: Positive—lots of requests for lectures, consultations, and assistance. The article articulates a sound scientific framework for causal evidence of effectiveness as a basis for employment of a single Phase III trial, in conjunction with causal evidence from earlier studies.

Q: What are the biggest obstacles to wider use of simulated or modeled trials?
A: Lack of awareness and understanding among senior industry executives, and too few experts to provide talent for companies.

Q: Are modeling and simulation sufficiently appreciated in industry?
A: Appreciation and use of clinical trial modeling and simulation is growing in the pharmaceutical industry, but has a long way to go. Most of the Big Pharma companies have experimented with it. Some have recruited small to large staffs to implement modeling and simulation extensively.

Q: What about the FDA—is it up to speed?
A: The FDA has long been ahead of the industry in use of simulation—it has a growing number of pharmacometric experts who are very familiar with this technology, and led the way beginning in the early 1990s. Simulation is encouraged in some of its recently published guidances (e.g., population pharmacokinetics, exposure-response guidances).

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