SYSTEM FOR COST EFFECTIVE CLINICAL TRIAL DESIGN

The long-term objective of this project is to develop software to facilitate the design of cost effective clinical trials. In 1999, the pharmaceutical industry and NIH spent more than $23 billion on clinical trials. Developments in clinical trial design theory, and in optimization algorithms have opened possibilities for more cost- effective designs that can be executed for lower total cost, over shorter periods of time and / or requiring fewer patients. The proposed System for Cost Effective Trials (SCET) will be a software package to guide the trial designer through comparisons of the power, sample size requirements, and cost of alternate trial designs. These methods are under-used throughout medical research, but are particularly applicable to trials with relatively short treatment regimens and rapid ascertainment of endpoints, such as many cancer treatment trials. The aims of SCET Phase II are to build the system, validate it in compliance with FDA regulations for software validation, perform Beta testing at a range of target client organizations, and use the Beta test findings to produce a marketable release. PROPOSED COMMERCIAL APPLICATION: The potential market for this software system includes virtually every pharmaceutical company in the world (multiple licenses to each), every biotech company involved in clinical trials, every contract research organization involved in the design or conduct of clinical trials, coordinating centers of NIH-sponsored multi-center clinical trials, individual university-based investigators who conduct clinical trials, individual biostatistical consultants who design clinical trials, and agricultural businesses and researchers that conduct animal research.