Regulatory authorities in the US and Europe have published “Guidance Documents” on the use and implementation of adaptive design trials.
- European Medicines Agency (EMA) – Reflection Paper on Methodological Issues In Confirmatory Clinical Trials Planned With An Adaptive Design (October 2007)
- US Food and Drug Administration (FDA) – Draft Guidance – Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics (February 2010)
- US Food and Drug Administration (FDA) – Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (February 2010)
- US Food and Drug Administration (FDA) – Draft Guidance- Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (December 2012)
These documents include helpful definitions for “adaptive trials” as well as important points to consider before embarking on the design and implementation of an adaptive trial. This includes an absolute requirement for prospectively written SOPs and working processes for executing adaptive trials and a recommendation that Sponsor Companies engage with CROs that have the necessary experience in running such trials.