Initiative to Modernize Eligibility Criteria for Clinical Trials Launched

May 17, 2016

ASCO and Friends of Cancer Research have launched a collaborative effort to modernize eligibility criteria to promote greater patient participation in cancer clinical trials. Eligibility criteria are standards that determine who can participate in a particular trial and often exclude individuals based on characteristics such as type and stage of disease, previous treatment history, age, and other medical conditions.

Although important for defining the population under study and ensuring patient safety, overly-strict eligibility criteria may limit clinical trial accrual, the generalizability of trial results to the larger population of cancer patients, and patient access to investigational therapies. The ASCO-Friends of Cancer Research initiative is designed to identify opportunities where eligibility criteria could be broadened, and ultimately influence investigators and sponsors to adjust these criteria where clinically appropriate.

As a first step, the two organizations established a multidisciplinary group of more than 40 stakeholders from across the cancer research community, including patient advocates, clinical investigators, drug and biotech manufacturers, pharmacologists, and medical reviewers from the U.S. Food and Drug Administration (FDA). Participants were organized into four working groups to consider the potential for broadening eligibility criteria in four specific areas: patients with brain metastases, minimum age requirements for trial enrollment, HIV/AIDS patients, and those experiencing organ dysfunction.

On May 12, the working groups presented their initial recommendations for discussion at a closed workshop that was attended by additional patient advocates, officials from the FDA, and drug and biotech manufacturers.

The working groups will finalize consensus recommendations in each of the four areas, with the ultimate plan of submission for publication in a peer-reviewed journal expected later this year.

The initiative builds on ASCO’s ongoing efforts, including a JCO article  that identified the regulatory and investigational challenges and issues in modernizing eligibility criteria for clinical trials in the age of molecular therapy. The article specifically looked at molecularly-driven trials, identifying the need to redefine eligibility criteria because of the small number of patients whose cancer has the genomic alteration being targeted, especially with the continued growth of newly-developed molecularly targeted therapies.

Stay tuned to ASCO in Action for future updates on this unique project.