“Adaptive clinical trials today are the new approached to Drug development especially in oncology. The need for looking at adaptive clinical trials is being felt because of the drug developing companies because of the rising failures in Phase III clinical trials. Since enough is not known about a new chemical entity in early stages of clinical trials, it is best to adopt the adaptive method of clinical trial design.
Adaptive clinical trials could lay the foundations for avoiding late stage failures which are very expensive as they are conducted across 1000′s of volunteers in various geographical locations in varying populations.
Getting the dose right through well-designed phase I and phase II trials is the best way to maximize success in phase III, which then leads to a higher rate of NDAs. ”
“Phase I studies are not allowed in India for molecules discovered outside India. Most Indian companies who are in “”active”” Research and development are forced to go to Europe and USA to conduct the First in Man where they face more delay. Getting to know the scientific world in the west is becomes a milestone task for the clinical research professionals.
Moving in clinical research in CRO’s and pharma would lead to professionals facing a lacuna in their learning pathways. The need of the hour is to know what is going on in developing world and in the clinical Research science.
The DCGI needs to take steps to allow Phase I studies in India. Unless this takes place and takes a meaningful direction, the growth of the Indian CRO market cannot be taken to the next anticipated level.”