Many Phase II trials can be handicapped in their probability of a confirmatory outcome either due lack of a comparator (or even placebo) or due to end of treatment “survival” type endpoints. This kind of trial can benefit greatly from a Bayesian adaptive methodology.

Similarly, increased attention has been drawn to adaptive trial designs particularly for narrow safety/ efficacy margin therapies e.g. in oncology, in expensive therapies e.g. monoclonal treatments and for special populations e.g. pediatrics.

Dynakin as a Commercial Research Organization (CRO) has collaborated with the industry in the design and performance of Phase II mutli-centric adaptive trials in pediatric populations that have become exemplary for regulatory agencies. Similar application of the company’s expertise is now being deployed in an oncology development program.