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ASCO: ‘Smaller, smarter’ cancer trials will yield more meaningful results

ASCO recently released new recommendations designed to increase the likelihood of “clinical meaningful outcomes” in trials for advanced pancreatic, lung, breast and colon cancers.

The recommendations — developed by the ASCO Cancer Research Committee in conjunction with other experts and patient advocates, and published in the Journal of Clinical Oncology — establish OS goals for clinical trial designs that are intended to significantly extend the lives of people with cancer.

“We’re urging our colleagues to implement clinical trials that if successful, would provide a significant and clinically meaningful improvement in survival,” Lee M. Ellis, MD, FASCO, immediate past chair of the ASCO Cancer Research Committee and lead author of the article, said in a press release. “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 note the 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, which often 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,” 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.”

ASCO also recommended 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.