Aptiv Solutions has announced publication of a Tufts Center for the Study of Drug Development (CSDD) report on the adoption and impact of adaptive trial designs, research funded by an unrestricted educational grant from Aptiv.
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 the research, and adoption should increase significantly in the next few years, particularly for exploratory phase trials. In a session previewing the report, the majority of 40 executives from top pharmaceutical companies agreed 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 sponsors $100 million 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,” said Pat Donnelly,cChairman and CEO of Aptiv Solutions. “Yet, barriers remain to this approach reaching its full potential to protect patients and free R&D dollars for more therapies and devices.”
“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,” said Ken Getz, director of sponsored research at Tufts CSDD. “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.”
“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” said Donnelly.
Aptiv Solutions is a global development services company focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. It offers adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization.