What Keeps Patients Out of Clinical Trials?

Lori M. Minasian, MD; Joseph M. Unger, PhD


J Oncol Pract. 2020;16(3):125-127. 

In This Article

What Keeps Patients out of Clinical Trials?

The conduct of clinical trials is key to identifying better ways to prevent and detect cancer in persons at risk and to treat patients diagnosed with cancer. Unfortunately, while patient participation in a clinical trial is entirely voluntary, few patients actually have the opportunity to consider trial participation. Instead, a combination of structural and clinical barriers intercedes to bar opportunities for trial participation for most patients. There are multiple fronts by which to improve the drivers underlying the system, and we offer three of them here.

Much of the literature about accrual to clinical trials has focused on the patient's willingness to participate. Seldom have researchers considered the entire trial decision-making pathway for patients. We previously conducted a systematic review of the literature and found 7,576 articles and abstracts matching the search terms "clinical trial accrual", "clinical trial enrollment", "enrollment in clinical trials", "clinical trial enrollment barriers", and "patient participation in clinical trials" in combination with the term "cancer." Among these, only 13 studies explicitly examined the entire clinical trial decision-making pathway beginning at patient diagnosis.[1] We found that no trial was locally available for 56% of all patients with cancer, representing a structural barrier to clinical trial participation of considerable magnitude. Among remaining patients, 21% were not eligible for a trial. Thus, for more than three (77%) of four patients with cancer, the opportunity for the patient's physician to offer a trial and for the patient to volunteer to participate is not even possible. Under these conditions, patient choice has limited influence on the overall pattern of trial participation.