The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be foundon the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCOto the FDA.