Estimating the cost of clinical innovation: parametric analysis of late stage pharmaceutical R&D

摘要

Major pharmaceutical companies are placing significant emphasis on reducing spiralling R&D expenditures and improving productivity. Clinical trials cost estimates positively affect the quality of stop/go decision making in late stage clinical development. The major quantitative challenge has been identified as how to estimate a priori the cost of clinical trials and prior research on this subject has been based upon a limited sample of drugs in development and depends upon average cost data released by the industry. The application of parametric cost analysis to pharmaceutical development can help reduce the uncertainty and the degree of approximation of the cost estimates.