The SPCD method incorporates two sequential placebo-controlled stages into the process, the second of which includes a re-randomization of placebo non-responders from the first. Also, due to its basic structure, SPCD is designed to reduce the number of patients required for a given trial by 20 to 40%.
PPD can now offer its clients this approach for conducting depression, pain and other psychiatry trials. PPD plans to continue RCT Logic’s practice of offering licenses to any qualified trial sponsor.
“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. “The pharmaceutical industry and regulatory agencies have long recognized the need for a more robust and efficient option for conducting clinical trials. We anticipate these and other stakeholders will be receptive to the design and apply it to appropriate clinical settings.”