Countless clinical trials are done in by unexpectedly well-performing placebo arms, a phenomenon particularly common in psychiatric studies. PPD believes a new, proprietary trial design can substantially level the playing field, and the CRO has paid an undisclosed sum to get its hands on the technology.
Developed by researchers at Massachusetts General Hospital, sequential parallel comparison design (SPCD) is meant to decrease the impact of the placebo effect in clinical trials by enrolling patients more efficiently. The design employs two sequential placebo-controlled stages, rerandomizing placebo nonresponders from the first and studying them again in the second.
The effect is two-fold, PPD said, at once reducing the number of patients needed by 20% to 40% and reducing the factors that can lead to an overstated placebo effect.
The CRO has acquired rights to the technology from RCT Logic, which held an exclusive license from MGH. The design, which PPD brands as Trimentum, is playing a role in 22 completed, ongoing or planned trials, the company said, and PPD believes its global reach will help expand adoption around the industry.
"Through Trimentum, PPD can offer our clients a clinical trial method that derives more information from fewer patients," Vice President Daniel Burch said in a statement. "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."
- read the statement