Predicting Screen Failure Rates of Human Abuse Potential Studies

Summary

Human Abuse Potential (HAP) studies are required for New Drug Approvals of all drugs that have a potential psychoactive effect. The steps of conducting a HAP study include, screening, drug discrimination, testing and discharge. The Study duration and cost are largely influenced by the screening Inclusion and Exclusion criteria, which includes setting an acceptable range of laboratory analytes. There is tremendous variability in what is an acceptable range of laboratory screening criteria by sponsors. This variability makes it difficult to predict study cost and duration of the study. It is crucial for research sites to accurately predict cost and duration of a study to ensure there are sufficient resources available for the study as well as to meet sponsor time line and cost consideration. The aim of this study was to evaluate the ability to accurately predict screen success rate and cost based upon sophisticated algorithms using historical data from previous HAP studies.