Possible Causes of Failing to Meet Primary Endpoints: A Systematic Review of Randomized Controlled Phase 3 Clinical Trials in Patients With Non-Small Cell Lung Cancer.
Mitsugu IkedaTatsuya OchibeMasahiro TohkinPublished in: Therapeutic innovation & regulatory science (2018)
Our findings suggest that the selection of the primary endpoint and the pretrial estimate can potentially impact the results of phase 3 clinical trials in patients with NSCLC and are critical success factors when planning phase 3 clinical trials.