ASCO Urges Raising the Bar for Cancer Clinical Trials
The American Society of Clinical Oncology is calling on cancer researchers, clinical trial sponsors, and drug developers to employ clinical trial designs that aim to significantly extend the lives of people with cancer. In a Special Article published in the Journal of Clinical Oncology, Ellis et al outlined overall survival goals for cancer clinical trials in several diseases that researchers should aim for and that patients should expect. The recommendations, developed by the ASCO Cancer Research Committee working with other experts and cancer patient advocates, provide examples of "clinically meaningful outcomes" in four types of cancer: advanced pancreatic, lung, breast, and colon cancers.
Improving the Design of Clinical Trials
"We're urging our colleagues to implement clinical trials that, if successful, would provide a significant and clinically meaningful improvement in survival," said Lee M. Ellis, MD, FASCO, Immediate Past Chair of the ASCO Cancer Research Committee and lead author of the article. "People with cancer are living longer due to new therapies that target specific molecular drivers of cancer. As our understanding of the molecular drivers of cancer expands, we should be able to design clinical trials that achieve better results."
The authors noted that additional benefits associated with "raising the bar" include the ability to design smaller and smarter clinical trials that can be conducted faster than larger trials that aim for smaller benefits for patients.
"These aspirational trial goals must be based on sound, reliable preclinical studies that provide the foundation for significantly improving outcomes for our patients," Dr. Ellis said. "In our recommendations, we also address the importance of quality of life and toxicity issues. If a patient experiences more toxicity than with current therapies, the therapy should provide a greater benefit."
Biospecimen Banks
ASCO also recommends that clinical trial sponsors establish comprehensive biospecimen banks for each trial, with informed consent from patients, so researchers can connect biospecimens with treatment outcomes to better understand which patients are most likely to benefit from treatment. Access to information about patients' outcomes will enable investigators to ask scientific questions before and after trials are completed—a step that would better enable the discovery and validation of biomarkers that can help guide treatment planning.
Development of ASCO's recommendations involved a public comment process and review by the ASCO Board of Directors. The ASCO Cancer Research Committee established working groups to study the unmet needs in four cancers—pancreatic, lung, breast, and colon. The working groups, composed of experts and patient advocates for each cancer type, identified the most optimal, yet feasible, goals for future clinical trials that would offer meaningful benefit to patients and significantly improve the duration and quality of life.
In addition to being a priority topic area for the committee and working group leadership, the recommendations are also connected to ASCO's research report "Accelerating Progress Against Cancer: ASCO's Blueprint for Transforming Clinical and Translational Cancer Research."
The draft recommendations were released in April 2013 for public comment and discussed at ASCO's 2013 Annual Meeting. The groups were led by Emile Voest, MD, PhD (pancreas), Roy Herbst, MD, PhD (lung), Lowell Schnipper, MD (breast), and Alan Venook, MD (colon).
Dr. Ellis is the corresponding author for the Journal of Clinical Oncology article.
For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
