The study question drives the design, not the other way round. From BOIN and CRM dose escalation to MCP-Mod, seamless Phase II/III designs, sample-size re-estimation and Bayesian borrowing, every approach is tested through simulation before it goes into a protocol.
An adaptive design should add flexibility for a clear reason. We assess whether it improves the way the study answers its key question, then test the approach thoroughly before it is built into the protocol.
Most clinical development programmes still rely on group-sequential, fixed sample-size designs because more flexible approaches bring additional methodological and operational complexity. But complexity alone is not a reason to avoid them. The right adaptive design can reduce unnecessary patient exposure, support earlier decisions and help a study respond more intelligently to emerging evidence.
Metronomia’s biostatisticians bring both the methodological expertise and regulatory experience needed to design adaptive trials with the registration pathway in mind. Our team has supported more than 50 regulatory interactions involving adaptive designs in the past five years, including scientific advice with FDA and EMA.
We use rpact, PASS and in-house Bayesian simulation tools to develop and test each design before implementation. Operating-characteristic simulations assess type I error, power, expected sample size and stopping probabilities across plausible scenarios. This gives sponsors the evidence needed to explain and defend the design to internal teams, IDMCs and regulators.
