RESEARCH TRIANGLE PARK, N.C. — Quintiles Transnational, a contract research organization for the life science industry, has formed a unit to help clients conducting clinical trials.
The Strategic Biostatistics Unit will focus on “adaptive design” and other statistical methods for clinical trials. Adaptive refers to modification of a feature within a trial based on data that accrues during a trial. The modifications do not compromise the integrity of the trial and follow Food and Drug Administration guidelines, Quintiles said.
“The FDA’s Critical Path Initiative highlights adaptive design as one way to reduce the time and costs of clinical drug development while retaining the ability to reach good statistical decisions,” said Stephen Smeach, senior vice president of Global Biostatistics & Medical Writing for Quintiles. “We’re at the cutting edge with respect to adaptive design, both for Phase III and for Phase IIB-III trials. The FDA’s facilitation of adaptive design methodology could in many cases lead to getting new medicines to patients faster and at less cost.”