Estimation of New Drug Product Approval Probabilities in Phased Clinical Trials

Abstract

This paper proposes and presents a method for the estimation of approval probabilities of new drug or product. The proposed method assumes that three evaluation communities are used to assess and evaluate the quality of a new drug or product and that the evaluation is done by the committees in three period phased clinical trials of the drug product using matched samples of subjects at each phase. Estimates of absolute and conditional approval probabilities by various combination evaluation committees at each phase of clinical trials are provided. Test statistics are also developed testing desired hypothesis at each of the phased clinical trials. The proposed method is illustrated with some sample data. It is shown in terms of estimated probability that it is more difficult for all three evaluation committees to be in complex agreement to approve or not approve a new drug or product than for fewer evaluation committees to grant approval.