New Drug Approval Probability Model in Phased Clinical Trials

Abstract

Modern medicine brought with it “evidence-based practice”, which demands that a diagnostic test or treatment method or drug to be used on humans must be proven to be at least safe and efficacious; and the result from the use of such must be reliable and repeatable. These days, the need for evidence-based practice has become even more imperative. Evidence-based practice extends to veterinary practice and also to non-medical practices, for instance in oil exploration. To satisfy these demands in drug testing, robust statistical methods of assessment and ethical procedure must be employed. We here develop and present a probability model for the approval of a new drug intended for use in man or animal. The model showed that there should be more than one evaluation committee working on the approval of one drug at a time. This approach would help in minimizing the error of approving wrongly drugs that should never have been approved. The proposed method has proven the workability and value of using at least three independent evaluation committees, working with the same sets of criteria, in assessing the basis for the use of a new drug and its approval.