Reducing cancer trial barriers
WASHINGTON, D.C.—The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) have submitted to the U.S. Food and Drug Administration (FDA) recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: 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,” said ASCO President Dr. Monica M. Bertagnolli. “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.”
Eligibility criteria lay out the characteristics that potential clinical trial participants must meet to participate and often include age, current health status, gender, medical history and particular type of cancer and its stage. By defining the characteristics of the study population in this way, researchers can better understand the efficacy and toxicity of the study treatment and minimize the impact of confounding factors on interpretation of the study results, ASCO and Friends note; however, with more stringent eligibility criteria, fewer patients qualify to participate, making the results less applicable to treat the more diverse patient populations seen in routine clinical practice.
“By reviewing and updating eligibility criteria, significant new opportunities can be given to patients who have historically been excluded,” said Jeff Allen, president and CEO of Friends of Cancer Research. “We commend the FDA and the NCI not only for their willingness to collaborate with external stakeholders to tackle such an important issue, but their commitment to the execution of what will undoubtedly benefit thousands of patients.”
In early 2016, ASCO and Friends launched a collaborative effort to modernize eligibility criteria and promote greater patient participation in cancer clinical trials and, in so doing, they identified five eligibility criteria that were most likely to restrict a patient’s participation in a trial but least likely to affect the safety of participants. In October 2017, the two organizations published a joint research statement providing a comprehensive examination of eligibility criteria for cancer clinical trials with recommendations to address eligibility criteria in these five specific areas. To help implement these recommendations, ASCO and Friends next drafted guidance documents with rationale and instructions for expanding eligibility criteria in each of these areas:
FDA plans to review the ASCO-Friends recommended language as the agency finalizes draft guidance documents to release for public comment.