Pharmaceutical Product Development (PPD), a Wilmington, N.C.-based CRO, has acquired RCT Logic's exclusive license from Massachusetts General Hospital (MGH) for the portfolio of patents related to its sequential parallel comparison design (SPCD).

SPCD is an alternative method for conducting well-controlled clinical trials that substantially decreases the impact on trial outcomes of any placebo effect and will enable PPD's clients to reduce the time and cost of conducting their clinical trials. This methodology, which PPD is branding as Trimentum, has been particularly effective in studying major depressive disorder (MDD), but is applicable to clinical trials in many disease areas where outcomes can be affected by placebo effects.

"Through Trimentum, PPD can offer our clients a clinical trial method that derives more information from fewer patients. As a result, our clients will be able to conduct smaller, more efficient trials in all stages of drug development, enabling more informed investment decisions and accelerating the delivery of much-needed new medicines," said Daniel Burch, M.D., PPD vice president of global product development and therapeutic area head for neuroscience.

A total of 22 SPCD trials are completed, ongoing or planned. These include phase II and phase III trials by corporate sponsors that are licensees of RCT Logic, as well as trials with the NIH and charitable funding.

The SPCD method, which 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, dramatically lessens the impact of the placebo effect in clinical trials by incorporating two sequential placebo-controlled stages into the process, the second of which includes a re-randomization of placebo non-responders from the first.

Trials in psychiatric indications are particularly vulnerable to placebo effects due to the subjective nature of the assessments, because some of the responses may relate to actual improvement in the patient's condition while others may relate to expectancy, trial design or implementation flaws. Due to its basic structure, SPCD reduces the number of patients required for a given trial by 20% to 40%. This not only decreases the cost and time it takes to conduct a trial, but also eliminates some of the factors that make results more difficult to interpret.

PPD now owns an exclusive license from MGH and can offer its clients this unique approach for conducting depression, pain and other psychiatry trials. PPD intends to continue RCT Logic's practice of offering licenses to any qualified trial sponsor.

PPD also is associated with the MGH Clinical Trials Network & Institute (CTNI). The affiliation with CTNI will enrich PPD's neuroscience expertise and capabilities by providing PPD's clients with access to researchers in clinical indications that include depression and schizophrenia in approximately 250 global clinical research sites, as well as patient quality services.