Qualitative study of Oncology Clinicians’ Perceptions of Barriers to Offering Clinical Trials to Underserved Populations

Introduction Cancer clinical trials represent the “gold standard” for advancing novel cancer therapies. Optimizing trial participation is critical to ensuring the generalizability of findings across patients, yet trial enrollment rates, particularly among minority and socioeconomically disadvantaged populations, remain suboptimal. Methods We conducted in-depth interviews with oncologists at a large academic medical center to explore their (1) attitudes and perceived barriers to offering clinical trials to minority and socioeconomically disadvantaged patients, and (2) recommendations for improving the enrollment of minority and socioeconomically disadvantaged patients in cancer clinical trials. Results Of 23 medical oncologists approached, 17 enrolled (74% response rate; mean age = 47; female = 42%; White = 67%). Content analysis revealed several barriers to enrollment: (1) ethical dilemmas; (2) ambivalence about trial risks and benefits; and (3) concern about patient well-being. Concerns about the legitimacy of informed consent, perceived lack of equipoise, and fear of personal bias influenced clinicians’ decisions to recommend trials during treatment discussions. Concerns about creating an imbalance between trial risks and benefits among patients with high-level needs, including patients with literacy, psychiatric, and other socioeconomic vulnerabilities, impacted clinicians’ enthusiasm to engage in trial discussions. Clinicians identified patient, provider, and system-level solutions to address challenges, including increasing patient and clinician support as well as involving external personnel to support trial enrollment. Conclusion Findings reveal multi-level barriers to offering cancer clinical trials to underrepresented patients. Targeted solutions, including system level changes to support clinicians, patient financial support, and implementation of clinical trial navigation programs were recommended to help reduce access barriers and increase enrollment of underrepresented patients into cancer clinical trials

Fertility preservation in reproductive-aged female patients with colorectal cancer: A scoping review

The objective of this scoping review is to describe and identify gaps in the existing literature on fertility preservation counseling received by young female patients with colorectal cancer

What is the magnitude of trial-associated, planned time and procedure burden for participating in phase 1 cancer trials? A cross-sectional study

Participation in phase 1 cancer clinical trials involves a commitment of time and effort for patients that can be understood in terms of “time toxicity”. In this project, we will measure the planned time patients commit to phase 1 trial participation primarily by calculating the number of planned research days per patient. We will also compare this outcome to progression-free survival time, and describe burdens in terms of trial procedures (e.g. biopsies) as well as trial restrictions and requirements (e.g. contraception). Planned research days will be calculated by determining average length of trial duration and consulting assessment schedules found in trial protocols on ClinicalTrials.gov. We will conduct a search of trial registries meeting our eligibility criteria and calculate the number of planned research days for each trial using assessment schedules by counting number of visits, where each visit is considered a planned research day. This study will describe some of the time patients commit to drug development in the context of advanced disease. Rendering this contribution more visible can stimulate discussions concerning how policymakers can best steward patient contributions to drug development. It can also stimulate discussions about reducing patient burden associated with trial participation