Can We Accelerate Drug Development?

Abstract

The process of drug development from discovery to marketing is so complex and expensive that it needs to take place on a truly international scale to be cost effective. The New Drug Application (NDA) or equivalent documents have to be assembled with the minimum of duplication of effort and the maximum of efficiency. The planning of the clinical part of drug development should take place well in advance of a drug entering the clinical trial stages. Such planning should include critical path analysis to allow realistic time tabling and adequate resource allocation. Suitably trained and experienced people should be allocated to the various tasks and through team building and shared goal setting, an optimal working environment must be created. Given the prescribed nature of clinical development, the opportunities for increasing speed include maximizing the efficiency of each step, searching for areas of potential overlap between preclinical and clinical phases and between Phases I–II and II–III. To ensure safety during accelerated drug development it is important to design the database for the whole clinical development process at the start of the clinical trial program. Predetermined “flagging” for specified frequency of Adverse Drug Reactions (ADRs) and trend analyses for laboratory data should be built-in to the database