低收入和中等收入国家癌症临床试验中患者及患者团体的参与

We conducted qualitative focus group discussions (FGD) with cancer patients and patient groups in low- and middle-income countries (LMICs) to understand their role in the cancer clinical trial ecosystem and identify strategies to improve engagement. These FGDs are part of a broader mixed-methods effort led by the National Cancer Institute to better characterize the clinical trial landscape in LMICs. Participants from six WHO regions were recruited through partner organizations, which disseminated email invitations including a link to a recruitment form collecting demographic and clinical trial experience information. Individuals in LMICs who have lived experience with cancer were invited to attend. Nine 90-minute semi-structured FGDs were conducted with 45 participants from 25 countries. Interviews were recorded, transcribed, and double-coded in Dedoose using directed content analysis. Most participants reported their primary role as a cancer patient advocate or person with cancer or survivor (33/45). Most participants said that patients and patient groups are not systematically involved in clinical trials, citing limited awareness about value of engagement and perceived researcher resistance as the greatest challenges. Limited availability of trials in LMICs and poor standard of care emerged as major challenges. When involved, engagement activities included educating patients about clinical trials and supporting recruitment. Participants described an ideal role that included serving as a bridge between patients and researchers, with involvement sought by researchers from design through dissemination. Participants noted several facilitators to increase patient engagement, including knowledge about the clinical process, access to information about specific clinical trials, capacity building for both patient groups and researchers, and implementing a formal process and compensation for engagement. Improving cancer care quality and access emerged as an important priority for many. This study provides an initial assessment of patient and patient group involvement in cancer clinical trials in LMICs from the perspective of people with lived experience. Findings reveal a gap between current and ideal levels of patient and patient group engagement, driven by limited awareness, structural barriers in LMICs, and perceived researcher resistance. Strengthening awareness, capacity, and structured mechanisms for involvement may enable patient groups to serve as effective bridges between communities and researchers and help improve patient-centered cancer care globally.