Expanding Cancer Clinical Trial Eligibility to Include More Patients

With the development of new and promising cancer treatments, the need for efficient and effective clinical trials has become increasingly important. The National Cancer Institute (NCI) has prioritized maximizing the number of patients eligible for these trials, addressing the challenge of enrolling sufficient participants. Historically, eligibility criteria have not evolved with the modernization of clinical trials, creating significant barriers for many patients and limiting the generalizability of study findings.

In response, NCI has taken steps to broaden eligibility criteria for some of its funded trials. Efforts include encouraging researchers to relax upper age limits in adult trials and allowing individuals with cancer who are HIV+ to enroll, when appropriate. Since 2016, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research have collaborated to further expand these criteria, aiming to accelerate advances in cancer treatment by enabling more patients to participate in trials.

Eligibility criteria are crucial for ensuring that trial participants are similar in terms of specific factors like cancer type and stage, general health, and previous treatments. This similarity helps ensure that trial outcomes are more likely the result of the intervention being tested rather than other variables. Additionally, these criteria are vital for patient safety, minimizing the risk of dangerous side effects from study drugs.

ASCO and Friends of Cancer Research formed four working groups in 2016 to develop recommendations for expanding eligibility criteria, focusing on variables that often exclude patients: brain metastases, HIV/AIDS, organ dysfunction, prior and concurrent cancers, and minimum age for enrollment. These groups conducted extensive reviews of scientific literature and clinical results to inform their recommendations, which were then compiled by NCI into a final document outlining new inclusion/exclusion criteria for NCI-sponsored trials. These criteria were implemented in November 2018 and include considerations for patients with viral infections like hepatitis B and C.

Despite these advancements, other barriers to clinical trial enrollment remain, including comorbidities and assumptions made by healthcare providers about patients' ability to participate. NCI encourages providers to present clinical trial options to patients, allowing them to make informed decisions about participation. Educating clinicians about clinical trials and patient enrollment is essential for increasing participation rates.

As the new eligibility criteria are relatively recent, their impact is yet to be fully evaluated. However, the ongoing effort to refine and expand these criteria aims to strike a balance between inclusivity and patient safety, with the goal of making clinical trial results more relevant to a broader patient population and accelerating the discovery of new cancer treatments.