Considering Whether Criteria for Clinical Trials Exclude Too Many Patients

May 3, 2018 | Advocacy & Policy

Clinical trials are a critical part of the development of new treatments. They rely on people who volunteer to participate and are then closely monitored by medical professionals in order to determine whether an investigational medicine is safe and effective for patients to use. When there is no treatment approved by the Food and Drug Administration (FDA) for a specific disease or when no approved treatments are successful for an individual patient, a clinical trial may offer the best chance of survival. This is especially true in rare cancers, which often have no FDA-approved treatment.

In a recent article in Nature, cancer researchers raised concerns that the criteria to participate in clinical studies excludes too many people.

Nearly 20% of publicly funded cancer clinical trials in the United States fail because investigators are unable to enroll enough participants. Yet patients and their physicians often grow frustrated when they encounter the sometimes insurmountable requirements to join a study.

Eligibility requirements are typically intended to protect either the participant or the study. Participants with some degree of liver failure, for example, might not be allowed to take part in a trial of a drug thought to pose a risk to that organ. Criteria might also exclude people with conditions that could confound the results of a study.

But some researchers say that a ‘cut-and-paste’ mentality has increased clinical-trial requirements over time, as scientists have used previous trial protocols as templates for their next studies. That may needlessly restrict participation in a trial.

The article referenced a joint project by the FDA, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research which found that five common criteria for cancer-trial eligibility could often be amended without posing harm to the participants or impacting the integrity of the trial.

In an op-ed in STAT News, Dr. David Gerber of the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center in Dallas elaborated on the benefits of broadening the criteria to participate in clinical trials: “Running clinical trials effectively and efficiently is critical to medical progress, not just in cancer care but across disciplines. Allowing more patients to be enrolled in trials will speed the medical innovation process, allow more sick people to access potentially beneficial therapies, and produce more generalized results.”