Fulwood, Dottington D.

PURPOSE There is limited cancer clinical research in sub-Saharan African countries despite the significant burden of cancers. The primary objective of this strengths, weaknesses, opportunities, and threats (SWOT) analysis was to understand and document factors affecting the successful implementation of prostate cancer (CaP) clinical research in Nigeria. METHODS The research team used a qualitative design involving International Registry of Men with Advanced Prostate Cancer (IRONMAN) study team members as participants from four regional sites in Nigeria. One-hour listening sessions were conducted via Zoom at each site, focusing on SWOT related to the IRONMAN study. All sessions were recorded, transcribed, and analyzed. Themes were inductively coded and then synthesized across all four sites. RESULTS The study teams identified several strengths and weaknesses in conducting the IRONMAN study at their respective sites. Key strengths included access to robust patient population for recruitment and the availability of essential resources, such as lab space, clinical knowledge, and adequate staffing. Weaknesses centered on the social determinants of health that hinder patient participation, such as transportation challenges, distance to clinics, limited access to care, and insufficient biorepository space for sample storage. A prominent opportunity identified was the potential for Nigerian institutions to engage in more clinical research, particularly multisite global trials. Threats included difficulties in retaining research staff and political instability. CONCLUSION This study highlights the promising research opportunities in Nigeria. The lessons learned from the IRONMAN study provide valuable insights into the feasibility of conducting CaP clinical research and trials tailored to the needs of Black men in sub-Saharan Africa. These findings offer a roadmap for future research efforts, with the potential to expand clinical trials and improve health outcomes across the region.

Abstract Background: The need to increase understanding of prostate cancer (CaP) is ever increasing. Unfortunately, there is limited understanding of how CaP affects men of African ancestry (MAA) despite significant disparities in CaP prevention, diagnosis, and treatment due to genetic and sociobehavioral factors. Conducting CaP clinical trials (CTs) in Africa presents multiple opportunities to improve upon collective knowledge of CaP in MAA experiences, expand patient access to CTs, and provide opportunities for African scientists and urologists to contribute to research on the global stage. The International Registry of Men with Advanced Prostate Cancer (IRONMAN) seeks to reduce CaP disparities by sponsoring sites throughout Africa. Four Prostate Cancer Transatlantic Consortium (CaPTC) institutions in Nigeria currently participate in IRONMAN: University of Ilorin Teaching Hospital, Federal Medical Center, University of Maiduguri, and Lagos State University Teaching Hospital. Because CTs of this scale are infrequently conducted in Africa, there are special considerations when conducting CTs in low-middle-income countries (LMICs) like Nigeria. Methods: Hourlong interviews dedicated to site staff were conducted via Zoom in Spring 2023 (four total). Interviews utilized a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis approach. Each interview was recorded, transcribed, and validated by study staff for accuracy. Themes from each were inductively coded and then collated across all four sites. Results: The urologists, oncologists, phlebotomists, pathologists, nurses, research coordinators that make up the study teams identified the holistics of conducting the IRONMAN study at their sites. Strengths included a large patient population to recruit from and appropriate resources to conduct the study (ex., lab space, clinical knowledge, staffing levels). Weaknesses included the social determinants of health that negatively impact patient participation, limited biorepository space to store samples, and the need for patient-physician trust. The greatest opportunity presented was Nigerian institutions joining more CTs in the future, particularly multi-site global trials. Described threats included staff turnover, national stability, and increased economic disparities. Discussion: While increasing the overall number of CTs in Africa is a noble cause, sponsors and institutions should note the unique circumstances in implementing CTs in Africa when designing CTs and recruiting sites. Listening to the experiences of study teams is pivotal in ensuring CTs are Africa-minded - they will be complimentary to established research infrastructure, appropriately funded, and culturally responsive all in the name of equitable research. By doing so, ethical compliance and quality data collection will ensue and reduce disparities at the micro, mezzo, and macro levels. Citation Format: Opeyemi Oreoluwa Bolajoko, Parisa Fathi, Oluwaseyi Toye, Dottington D. Fulwood, Ademola Popoola, Chidiebere Ogo, Hassan Dogo, Omolara Fatiregun, Anthonia Sowumi, Paul Jibrin, Mutiu A. Jimoh, Faruk Mohammed, Folakemi Odedina, Prostate Cancer Transatlantic Consortium. Strengths, weaknesses, opportunities, and threats of conducting clinical trials in Nigeria: The IRONMAN study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1013.