RCT Logic

Founded in 2007 by Matthias B. Bowman, RCT Logic, LLC developed and licensed clinical trial designs for entities in the United States, including industry sponsors, non-profits, and government bodies. The company was established to commercialize a novel clinical trial methodology aimed at mitigating the impact of the placebo effect, a significant variable in clinical research.

The company's core offering was the Sequential Parallel Comparison Design (SPCD), a patented clinical trial paradigm invented by Dr. Maurizio Fava and Dr. David Schoenfeld of Massachusetts General Hospital. SPCD works by incorporating two sequential placebo-controlled stages. The second stage involves re-randomizing placebo non-responders from the first stage, which substantially reduces the number of patients required for a trial by an estimated 20 to 40 percent. This process not only decreases the time and cost associated with clinical trials but also helps to eliminate factors that can complicate the interpretation of results. RCT Logic also offered a comparative analysis software calculator, allowing trial sponsors to determine design parameters for an SPCD trial and analyze its efficiency compared to conventional trial designs. The primary clients for this service were corporate sponsors, the National Institutes of Health (NIH), and charitable organizations conducting Phase II and Phase III trials, particularly in fields like psychiatry where subjective assessments are common.

The business model centered on licensing its patented SPCD technology to organizations conducting clinical trials. In a significant milestone, Pharmaceutical Product Development, LLC (PPD) acquired the exclusive license for the SPCD patent portfolio from RCT Logic in September 2014. PPD rebranded the methodology as Trimentum™ to offer its clients a more efficient trial method, enabling more informed investment decisions and accelerating drug development. This acquisition marked the culmination of RCT Logic's operations, having been an acqui-hired company that successfully transitioned its core intellectual property to a major contract research organization.

Keywords: clinical trial design, Sequential Parallel Comparison Design, SPCD, placebo effect mitigation, pharmaceutical development, biostatistics, clinical research solutions, drug development efficiency, PPD, Trimentum, Matthias B. Bowman, Maurizio Fava, David Schoenfeld, Massachusetts General Hospital, clinical trial software, healthcare technology, patent licensing, contract research organization, Phase II trials, Phase III trials