Clinically Meaningful Outcomes

ASCO Urges Raising the Bar for Cancer Clinical Trials, Encourages Researchers, Industry to Achieve More Meaningful Results for Patients

In a Special Article published March 2014 in the Journal of Clinical Oncology, ASCO outlines overall survival goals for cancer clinical trials in several diseases that researchers should aim for -- and 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. An accompanying editorial was also published in the Journal of Clinical Oncology in March 2014. Summary slides are available for download to help foster conversation and debate.

"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."  

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, molecular markers in the body that are signs of normal or abnormal conditions, 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."  

If you have any comments or questions, feel free to email us at researchpolicy@asco.org.