Journal Article

Common Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials

van der Graaf, Winette, Gyawali, Bishal, Goodman, Aaron M, Pond, Gregory R, Eisenhauer, Elizabeth A, Booth, Christopher M, Koven, Rachel, Pe, Madeline L, Mohyuddin, Ghulam Rehman, Tregear, Michelle, Tannock, Ian F, Soto-Perez-de-Celis, Enrique, Marini, Bernard L, Trapani, Dario, Cherny, Nathan I, Wilson, Brooke E, Sengar, Manju

2025

Overview

Common Sense Oncology (CSO) prioritises treatments providing meaningful benefits for people with cancer. Here, we describe CSO principles aimed at improving the design, analysis, and reporting of randomised, controlled, phase 3 clinical trials evaluating cancer treatments. These principles include: (1) control treatment should be the best current standard of care; (2) the preferred primary endpoint is overall survival or a validated surrogate; (3) an absolute measure of benefit should be provided, such as the difference between groups in median overall survival times or the proportion of surviving patients at a prespecified time; (4) health-related quality of life should be at least a secondary endpoint; (5) toxicity should be described objectively without subjective language diminishing its importance; (6) trials should be designed to show or rule out clinically meaningful differences in outcomes, rather than a statistically significant difference alone; (7) censoring should be detailed, and sensitivity analyses done to determine its possible effects; (8) experimental treatments known to improve overall survival at later disease stages should be offered and funded for patients progressing in the control group; and (9) reports of trials should include a lay-language summary. We include checklists to guide compliance with these principles. By encouraging adherence, CSO aims to ensure that clinical trials yield results that are scientifically robust and meaningful to patients.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Adjuvants / Bias / Biomarkers / Breast cancer / Cancer therapies / Check lists / Clinical trials / Clinical Trials, Phase III as Topic - methods / Clinical Trials, Phase III as Topic - standards / Endpoint Determination / Hematology, Oncology, and Palliative Medicine / Humans / Medical Oncology - standards / Metastasis / Neoplasms - mortality / Neoplasms - therapy / Oncology / Patients / Quality of Life / Randomized Controlled Trials as Topic - methods / Randomized Controlled Trials as Topic - standards / Research Design - standards / Sensitivity analysis / Statistical analysis / Survival / Toxicity