CRO PPD Acquires Trimentum Clinical Trial Method From RCT Logic
By Cyndi Root
Pharmaceutical Product Development, a contract research organization (CRO), announced in a press release that it has acquired Trimentum, sequential parallel comparison design (SPCD), from RCT Logic. The technology allows clinical trial sponsors a way to decrease the impact of the placebo effect. Recent trials in major depressive disorder (MDD) have shown the efficacy of the program, which is applicable to many disease areas.
Daniel Burch, M.D., VP of global product development and therapeutic area head for neuroscience at PPD, said, “Through Trimentum, PPD can offer our clients a clinical trial method that derives more information from fewer patients.”
PPD and RCT Logic, MGH Agreement
Massachusetts General Hospital (MGH) had previously granted an exclusive license for the portfolio of patents relating to SPCD to RCT Logic. The agreement between PPD and RCT Logic gives PPD the exclusive license from MGH. PPD will offer licenses to trial sponsors in psychiatry trials, including depression and pain. Through its association with the MGH Clinical Trials Network & Institute (CTNI), PPD will extend its neuroscience expertise to 250 global clinical research sites. Dr. Burch stated that the acquisition will enable clients to conduct smaller and more efficient trials.
SPCD
The SPCD method, which PPD is naming Trimentum, was invented by Maurizio Fava, M.D., director of clinical research and executive vice chair of psychiatry at MGH, and David Schoenfeld, Ph.D., of the MGH Biostatistics Center. The patented data analytics process incorporates two sequential placebo-controlled stages, including a re-randomization of placebo non-responders from the first stage, in turn lessening the impact of the placebo effect. In psychiatric trials especially, placebo effects are subjective. The SPCD method reduces by 20 to 40 percent the number of patients needed for trial. Currently, 22 SPCD trials are planned, underway, or complete. Participants include the National Institutes of Health (NIH) and corporate sponsors.
About PPD
PPD is a global CRO with offices and laboratories in 46 countries. In the past five years, PPD has conducted over 270 trials in the United States, Europe, Chile, Japan, and South Africa in the areas of psychiatry, neuroscience, and pain. PPD was founded in 1985, went public in 1996, and returned to privately held in 2011.