Guidance for discussants of randomized cancer trials at major meetings.
Elizabeth A Eisenhauer, Omar Abdihamid, Christopher M Booth, Nathan Cherny, Antonio T Fojo, Bishal Gyawali, Bernard L Marini, Ghulam Rehman Mohyuddin, Madeline Pe, Gregory R Pond, Enrique Soto-Perez-de-Celis, Ian F Tannock, Dario Trapani, Michelle Tregear, Winette T A van der Graaf, Brooke E Wilson
Author Information
Elizabeth A Eisenhauer: Queen's University, Kingston, ON, Canada. Electronic address: eae@queensu.ca.
Omar Abdihamid: Garissa Regional Cancer Center, Garissa, Kenya.
Christopher M Booth: Queen's University, Kingston, ON, Canada.
Nathan Cherny: Shaare Zedek Medical Center, Jerusalem, Israel.
Antonio T Fojo: Columbia University Irving Medical Center, New York, NY, USA.
Bishal Gyawali: Queen's University, Kingston, ON, Canada.
Bernard L Marini: University of Michigan, Ann Arbor, MI, USA.
Ghulam Rehman Mohyuddin: University of Utah, Salt Lake City, UT, USA.
Madeline Pe: European Organization for Research and Treatment of Cancer, Brussels, Belgium.
Gregory R Pond: McMaster University, Hamilton, ON, Canada.
Enrique Soto-Perez-de-Celis: University of Colorado, Denver, CO, USA; Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico.
Ian F Tannock: Princess Margaret Cancer Centre and University of Toronto, Toronto, ON, Canada.
Dario Trapani: European Institute of Oncology, Milan, Italy.
Michelle Tregear: National Breast Cancer Coalition, Washington, DC, USA.
Winette T A van der Graaf: Netherlands Cancer Institute, Amsterdam, the Netherlands.
Brooke E Wilson: Queen's University, Kingston, ON, Canada.
BACKGROUND: Discussants of potentially practice-changing randomized clinical trials (RCTs) at major cancer meetings have an important responsibility to place new research in the context of current cancer care, to assess the generalizability of the data, to evaluate whether the outcomes are meaningful to patients, and to convey this information effectively and objectively to a diverse audience. Without a standard approach to critiquing clinical trial design or results discussants may overlook key weaknesses in their commentary. COMMON SENSE ONCOLOGY (CSO): The CSO initiative was launched in 2023 and is now comprised of an international collective of >���1000 clinicians, academics, policymakers, and patients. Its primary vision is that patients should have access to cancer treatments that provide meaningful improvements in outcomes, irrespective of where they live. To do this, one focus is to try to improve evidence generation and reporting. GUIDANCE FOR DISCUSSANTS: As part of this work, the CSO RCT Working Group has identified key elements for use in the development of discussant presentations to facilitate a balanced high-quality examination of RCTs. Elements include assessment of: a) Study design: evaluation of the study question, selection of population and control arm, use of blinding, choice of primary and secondary endpoints; b) Study results: treatment delivery, use of crossover, impact of censoring, unplanned analyses, patient reported outcomes, adverse effects; and c) Conclusions: Appraise the value and generalizability of trial results and, when positive results are claimed, assess if they offer meaningful benefits over current standard(s) of care in outcomes of importance to patients.
