Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Pharmaceutical Product Development, LLC (PPD) announced today that it 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 significantly 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 impacted 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. “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.”
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 National Institutes of Health (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 percent. 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.
“Having one of the world’s leading contract research organizations continue to build on the success of SPCD is a great achievement for RCT Logic,” said Matthias Bowman, who founded the company in 2008. “We are excited that PPD will be able to help its clients accelerate the pace and reduce the cost of developing new medical therapies through the use of MGH’s patented SPCD technology. We are particularly enthusiastic about the implications for patients who are waiting for important new treatments.”
As a result of this acquisition, PPD 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 already broad 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.
“The leadership of CTNI has more than 25 years of experience in industry-sponsored multicenter clinical trials,” said Fava. “CTNI already has successfully conducted or is currently overseeing the implementation of the SPCD methodology in more than 10 trials with corporate, NIH and charitable funding. By building on that experience and collaborating with PPD, we hope to further enhance our ability to help our clients meet their clinical research goals more efficiently and more effectively.”
An industry leader in neuroscience drug development, PPD has conducted more than 270 studies during the past five years in a wide range of neurology, psychiatry and pain management indications across all phases of development. CTNI has managed numerous trials in the United States, Europe, Chile, Japan and South Africa. In addition to CTNI staff in the United States, the organization has clinical trials service agreements with institutions and clinicians throughout the world.