Regulatory Guidance for Adaptive Design Trials
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- US Food and Drug Administration (FDA) – Draft Guidance – Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics (February 2010)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- US Food and Drug Administration (FDA) – Draft Guidance- Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (December 2012)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.
For certain types of adaptive trial it is advisable to meet and discuss the trial design with regulatory agencies. This is particularly true for confirmatory trials. Aptiv Solutions has considerable experience in helping Sponsor Companies discuss their adaptive designs with regulatory agencies including pre-IND and end-of-phase II meetings with the FDA and scientific advice and protocol assistance meetings with the European authorities (EMA and National Agencies).
Our global regulatory team, in conjunction with our Innovation Center experts, will provide comprehensive support covering all the requirements for agency meetings including:
- Preparation of a simulation report and statistical analysis plan covering the adaptive design
- Data review and preparation of draft questions
- Preparation and submission of the formal meeting request
- Preparation of the briefing book including finalization of questions
- Management of meeting logistics and meeting rehearsal
- Attendance and representation at the meeting
- Authorship and review of meeting minutes