A free report from Tufts CSDD summarises key messages from a roundtable meeting that discussed the adoption and impact of adaptive design clinical trials.
Forty senior executives from a variety of cross-functional areas took part. In addition to facilitated discussion, Tufts CSDD presented the results of interviews conducted among directors and heads of statistical functions from a dozen major pharmaceutical companies and provided forecasted impact metrics based on a simple model of trial design adaptation
Findings from the report included:
- Across the industry, simple adaptive designs are used on approximately 20% of clinical trials. Participating companies report that they expect the adoption of adaptive trial designs in exploratory phase clinical trials to increase significantly over the next several years.
- Operating concerns (specifically delays and disruptions in trial execution, patient participation and distribution of clinical supplies) are the largest perceived barriers.
- Participants perceive that regulatory affairs functions are risk averse to adopting sophisticated adaptive design approaches due to their belief that more clarity from regulatory agencies is needed. Regulatory agencies, in contrast, appear highly receptive to exploratory phase adaptive trial designs (e.g., adaptive dose-finding studies) to challenge and inform clinical teams prior to committing to pivotal late-phase studies.