Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces publication of a Tufts Center for the Study of Drug Development (CSDD) report on the adoption and impact of adaptive trial designs.
Adaptive designs allow pre-planned modifications to clinical trials, such as terminating studies early to spare patients from ineffective drugs or adding patients to help ensure the trial will return a statistically significant result.
Approximately 20% of clinical trials currently underway already use adaptive designs, according to Tufts CSDD’s research. The study indicates adoption should increase significantly in the next few years, particularly for exploratory phase trials. In a session previewing the report, the majority of forty executives from top pharmaceutical companies agreed that futility analysis should become standard practice in all phase II and III studies. Data indicates widespread use of simple adaptive designs, such as early study terminations due to futility and sample size re-estimation, could save sponsor organizations $100 to $200 million annually.
“The industry is investing heavily in improving clinical trial quality and efficiency and now years of evidence has made the promise of adaptive designs clear. Yet, barriers remain to this approach reaching its full potential to protect patients and free R&D dollars for more therapies and devices,” says Pat Donnelly, Chairman and Chief Executive Officer of Aptiv Solutions.
“An important finding of our study was that a primary factor limiting adoption of adaptive designs is internal organizational resistance, not lack of support from regulatory agencies. Study participants believe that internal functions, for example regulatory affairs, are risk-averse and prefer more clarity from regulatory agencies. Regulatory agencies, on the other hand, have provided guidance, and appear to be receptive to exploratory phase adaptive trial designs,” says Ken Getz, Director of Sponsored Research at Tufts CSDD.
“Adaptive trials allow study sponsors to react to data acquired during an investigation and make adjustments, improving the utility of information the studies provide to patients, doctors, regulators, and sponsors. It’s like crossing the road with your eyes open. The time is right for sponsor companies to expand their use of adaptive designs” says Donnelly
The Tufts CSDD research was funded by an unrestricted educational grant from Aptiv Solutions and a copy of the report is available at: .
Aptiv Solutions is a global development services company that is focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has more than 850 professionals in North America, Eastern & Western Europe, Israel, and Japan. Visit the website at .
The () is an independent, academic, non-profit research group at Tufts University that provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.