Conclusion
Adaptive design is a double-edged sword. It is capable of expediting the
process of medicine development by reducing the study duration and
sample size. On the other hand, it may require more regulatory measures
for drugs for which the safety profile has not been rigorously
established. As a result, the importance of crisis awareness should be
raised because the number of medicines falling under AM is growing,
especially for those with adaptive scheduling in confirmatory trials. We
are curious to know what role adaptive design has in ongoing studies
when the drug is approved, the current regulations (AM, CMA, PASS) are
helpful to build up completed safety profiles for these drug are
expected to be explored and detailed in the future.