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What is the current regulatory approval process for starting a new phase III clinical trial in India? 

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Investigators should increase consideration of the potential impact on phase III trials to optimally select the proper trial design prior to phase II study implementation.
A greater investment in phase I and II drug trials may be required to provide the information necessary for phase III planning.
Journal ArticleDOI
Byron Jones, J. A. Lewis 
29 Citations
In summary, cross-over trials remain a potentially valuable research tool in the development of new medicines at all stages including phase III.
AIMS For ethical and economic reasons, interim analysis of phase III clinical trials is essential.
The choice of meta-analysis methods can influence the decision about whether a trial should proceed to Phase III and thus need to be clearly documented and investigated whenever a Phase II meta-analysis is performed.