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ResourcesWhat Keeps Patients Out of Clinical Trials? – Medscape (Lori M. Minasian & Joseph M. Unger | May 2020)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

What Keeps Patients Out of Clinical Trials? – Medscape (Lori M. Minasian & Joseph M. Unger | May 2020)


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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.

“Clinical trials are key to advancing cancer research, yet patient participation remains low. What factors may account for this?” We expected this to explore participants’ views, but this is more from the perspective of clinical trial coordinators. Nevertheless, it is a useful discussion.

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.

The findings above highlight how structural barriers at the institutional level dominate trial decision making. Institutional participation in research requires a substantial investment in the conduct and oversight of clinical trials. Even if an institution chooses to build a trial program, its physicians and other health care providers must then choose to serve as investigators or research staff in clinical trials. The challenges of implementing such a program were examined in two recent studies. The National Cancer Institute (NCI) Community Oncology Research Program (NCORP; previously the NCI’s Community Clinical Oncology Program [CCOP]) is designed to expand access to clinical trials and promote cancer treatment innovations for community-based patients who often have limited opportunity to travel to major cancer centers to receive care.[2] On the basis of data from 41 administrative, physician, and nurse key informants from five sites, McAlearney et al[3] identified several major themes representing the administrative, financial, and organizational challenges of implementing a clinical trial program at a community site, including a lack of understanding and appreciation of the value and conduct of trial participation, the cost of supporting the program and meeting program requirements, managing clinic workflow changes as they pertained to patient recruitment and physician involvement, and sustaining hospital leadership support.

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