Around 20% of clinical trials currently underway are using adaptive designs, while adoption of these techniques is likely to increase significantly over the next few years, particularly in the exploratory phase of drug development, a new report suggests.
A key finding of the report, published by the US-based Tufts Center for the Study of Drug Development (CSDD), was that one of the main factors limiting uptake of adaptive designs is internal organisational resistance, rather than 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,” explained Ken Getz, director of sponsored research at Tufts CSDD.
“Regulatory agencies, on the other hand, have provided guidance, and appear to be receptive to exploratory-phase adaptive trial designs,” Getz noted.
Standard practice
Adaptive trial designs involve pre-planned modifications such as terminating studies early to spare patients from exposure to ineffective drugs, or adding patients to help ensure the trial will produce a statistically significant outcome.
When consulted on the adoption and impact of adaptive trial designs, the majority of forty executives from top pharmaceutical companies agreed that futility analysis, for example, should become standard practice in all Phase II and III studies, Tufts CSDD said.
Data indicate that widespread use of simple adaptive designs, such as early study terminations due to futility and re-estimation of sample sizes, could save sponsor organizations US$100 million to $200 million per year, it added.
Promise clear
The Tufts CSDD research was funded by an unrestricted educational grant from Aptiv Solutions.
With industry investing heavily in improving clinical trial quality and efficiency, years of evidence have “made the promise of adaptive designs clear”, observed Pat Donnelly, chairman and chief executive officer of Aptiv Solutions.
Nonetheless, barriers remain to this approach “reaching its full potential to protect patients and free R&D dollars for more therapies and devices”, added Donnelly, who described adaptive trials as “like crossing the road with your eyes open”.
