March 2011 Optimal times for between-agency dialogue

As part of a survey conducted by CIRS, we asked both Regulatory agencies (DRA) and Health Technology Assessment (HTA) agencies when companies were approaching them for scientific advice about drugs in development and also about when these agencies might be willing to provide such advice. As the requirements for these two different types of agency are different, conflicting advice might be given at the same stages of development. Looking at the times in development when companies are approaching agencies for advice, we consider that the optimal time for between-agency dialogue would be in relation to the design of phase III trials such that the potential for conflict might be reduced via alignment between, or better understanding of, the requirements of the two agencies.