Operational Strategies for Clinical Trials in Africa

Abstract

<jats:sec><jats:title>PURPOSE</jats:title><jats:p> In a dramatic reversal of longstanding trends, cancer now kills more Africans than malaria. Despite Africa’s growing cancer burden, individuals of African descent, notably those residing in Africa, remain drastically under-represented in cancer clinical trials. Two recent summits—the 1st All Africa Clinical Trial Summit and the Operational Strategy for Clinical Trials in Nigeria Summit—convened experts from governments, the private sector, universities, and professional societies to define the barriers to Africa’s participation in multicenter clinical studies and the strategies to eliminate those impedances. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> The discussions held during the two clinical trial summits were condensed into a set of 10 recommendations covering five broad categories (funding, regulation, capacity building, Africa-centric approach, and patient engagement). In this article, four programs are presented as examples of how the summits’ recommendations can be put into practice to improve Africa’s ability to attract clinical trials, in particular, cancer clinical trials. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> These example programs all leveraged a multilateral, Africa-driven approach to building Africa’s clinical trial capacity, increasing visibility of Africa’s current clinical trial capabilities and priorities, improving regulatory infrastructure and enforcement on the continent, and optimizing patient and clinician engagement strategies. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> The four programs are anticipated to catalyze the involvement of more African health care sites in cancer clinical trials, enroll a greater number of African patients with cancer in those trials, and, ultimately, reverse Africa’s growing cancer incidence and mortality rates. Each program acts as a blueprint for organizations—whether government, academic, or industry—seeking to address the summits’ recommendations and increase Africa’s contributions to and active participation in clinical research. </jats:p></jats:sec>

Cancer Clinical Trials in Africa—An Untapped Opportunity: Recommendations From AORTIC 2019 Conference Special Interest Group in Clinical Trials

“…Pre- and post-training assessment revealed a significant rise in knowledge. The African Clinical Trials Consortium 35 organizes monthly webinars on different aspects of clinical trials with the aim of building a critical mass of clinical trialists in Africa. 35 These initiatives will develop the confidence of clinical trial sponsors and funding agencies to invest further in the continent.…”

“…The African Clinical Trials Consortium 35 organizes monthly webinars on different aspects of clinical trials with the aim of building a critical mass of clinical trialists in Africa. 35 These initiatives will develop the confidence of clinical trial sponsors and funding agencies to invest further in the continent. We encourage more of such opportunities to expose and train early career researchers by using stratified training (basic and advanced courses) and hands-on workshops.…”

Oncology Clinical Trials in Africa: Emerging and Operational Issues

“…This series concludes with a discussion of the operational strategies for clinical trials in Africa by Graef et al 18 The authors present African-driven practice model examples for 10 recommendations developed during the First All Africa Clinical Trial Summit and the Operational Strategy for Clinical Trials in Nigeria Summit. The recommendations focus on funding, regulation, capacity building, and an Africa-centric patient-centered approach.…”

“…Furthermore, it has revealed the threats of so-called guinea pig syndrome from scientists outside Africa, with French physicians proposing to test a COVID-19 vaccine in Africa, although there is lower incidence in African countries compared with France. 18 It is clear that African investigators need to take the lead on clinical trials in Africa while collaborating with other stakeholders within and outside Africa. We hope that this series will educate, prepare, and empower African investigators and other stakeholders toward enhancing clinical trials in Africa.…”

Unseen and unheard: African children with cancer are consistently excluded from clinical trials

“… 7 The National Comprehensive Cancer Network has stated that clinical trials are the best way to manage patients with cancer. 2 8 Unfortunately, this is not possible for most African countries where very poor prognosis has been linked to late presentation, malnutrition, treatment abandonment, lack of proper supportive services and need for drug dose modification. Undoubtedly, all these factors significantly affect low survival rates of childhood cancers in Africa and must be addressed systematically by strengthening health systems.…”