Modernization of Endpoints and Estimands of Late-phase Tuberculosis Therapeutic Trials

Abstract

The overall objective of this project is to improve the specification and, to the extent possible, the standardization of endpoint and estimand definitions across protocols, analysis plans and reports from late phase pulmonary TB therapeutic trials. To this end, we are using the estimand framework, as outlined by the ICH E9(R1) addendum, since it contains recommendations that are binding for trials conducted under ICH GCP. *Please feel free to send comments or suggestions as this estimands report is a living document that will continue to be updated.