Barriers and Opportunities for Cancer Clinical Trials in Low- and Middle-Income Countries.

Importance: Clinical trials represent the gold standard to test the safety and efficacy of new or updated approaches to treatments that will inform quality cancer care. However, cancer trials enroll few patients in low- and middle-income countries (LMICs), are often led by investigators from high-income countries, and do not adequately reflect global disease burden or population diversity. Objective: To identify key challenges and strategies to advance contextually relevant, quality cancer trials in LMICs. Design, Setting, and Participants: The survey used in this survey study was available in English, Arabic, French, Portuguese, and Spanish and was conducted by the US National Cancer Institute from October 18 to December 22, 2023. Clinicians with experience in cancer therapeutic clinical trials in LMICs were eligible. The survey covered their professional background and views on challenges and strategies for improving clinical trial opportunities in LMICs. Analysis was performed from April 2 to August 26, 2024. Main Outcomes and Measures: Respondents were asked to rate 34 challenges by impact on their ability to conduct cancer trials using a 4-point Likert scale and 8 strategies by importance using a 5-point Likert scale. Descriptive statistics summarized participants' backgrounds, challenges, and priorities. Results: Of 453 respondents who began the survey, a total of 223 (49%) were eligible for inclusion, and 131 of those (59%) completed the survey in full. Among the 133 respondents who provided gender data, 81 (61%) were male. In all, 107 of 130 respondents (82%) were affiliated with LMIC institutions, 65 of 223 (29%) were medical oncologists, and 52 of 133 (39%) were midcareer. Financial challenges were rated as the most impactful, with 133 of 170 respondents (78%) rating difficulty obtaining funding for investigator-initiated trials as having a large impact on ability to carry out a trial. Human capacity issues followed, with 105 of 192 respondents (55%) rating lack of dedicated research time as having a large impact. Increasing opportunities for funding and improving human capacity were reported as key strategies to advance capacity to conduct clinical trials in LMICs. Conclusions and Relevance: This survey study of clinicians with clinical trial experience in LMICs suggests that adequate funding and a well-trained research workforce are 2 predominant challenges to advancing cancer therapeutic clinical trials in LMICs. Understanding these obstacles can inform efforts to support cancer clinical trials that better reflect worldwide needs and diversity by prioritizing and sustaining research led by LMIC investigators.