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Common Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials - 04/02/25

Doi : 10.1016/S1470-2045(24)00451-0 
Bishal Gyawali, MD a, b, c, Elizabeth A Eisenhauer, ProfMD b, Winette van der Graaf, ProfPhD d, e, Christopher M Booth, ProfMD a, b, c, Nathan I Cherny, ProfMD f, Aaron M Goodman, MD g, Rachel Koven, MSc h, i, Madeline L Pe, PhD j, Bernard L Marini, PharmD k, Ghulam Rehman Mohyuddin, MD l, Gregory R Pond, ProfPhD m, Manju Sengar, ProfMD n, Enrique Soto-Perez-de-Celis, PhD o, p, Dario Trapani, MD q, r, Michelle Tregear, PhD s, Brooke E Wilson, MD a, b, c, Ian F Tannock, ProfMD t, u,
a Division of Cancer Care and Epidemiology, Cancer Research Institute, Queen’s University, Kingston, ON, Canada 
b Department of Oncology, Queen’s University, Kingston, ON, Canada 
c Department of Public Health Sciences, Queen’s University, Kingston, ON, Canada 
d Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands 
e Department of Medical Oncology, Erasmus Medical Center, Rotterdam, Netherlands 
f Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel 
g Department of Medicine, Division of Blood and Marrow Transplantation, University of California San Diego, San Diego, CA, USA 
h Patient & Family Advisory Council, Southeast Regional Cancer Program, Kingston Health Sciences Centre, Kingston, ON, Canada 
i Division of Cancer Care and Epidemiology, Queen’s University, Kingston, ON, Canada 
j European Organisation for Research and Treatment of Cancer, Brussels, Belgium 
k Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA 
l Division of Hematology and Hematologic Malignancies, Department of Medicine, University of Utah, Salt Lake City, UT, USA 
m Department of Oncology, McMaster University, Hamilton, ON, Canada 
n Tata Memorial Centre, Affiliated to Homi Bhabha National Institute, Mumbai, India 
o Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Denver, CO, USA 
p Department of Geriatrics, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico 
q European Institute of Oncology, IRCCS, Milan, Italy 
r Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy 
s National Breast Cancer Coalition, Washington, DC, USA 
t Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada 
u Department of Medicine, University of Toronto, Toronto, ON, Canada 

* Correspondence to: Prof Ian F Tannock, Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada Division of Medical Oncology and Hematology Princess Margaret Cancer Centre Toronto ON M5G 2M9 Canada

Summary

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.

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