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African Consortium for Cancer Clinical Trials (AC3T): Building cancer research and clinical trial capacity in Africa AAI Virtual Training Series for Cancer Clinical Trials

Cancer burden in Africa

Over the next decade, cancer mortality in Africa is projected to increase almost 50% - reaching 1 million annual deaths by 2030 [1]. By contrast, cancer mortality in the United States has declined 27% since 1991 due in large part to the availability of safe, targeted, and effective cancer therapies [2].

Demographic disparities in cancer research and clinical trials

The majority of cancer research is conducted in high-income countries. Less than 2% of cancer studies listed at ClinicalTrials.gov were conducted on the African continent with the majority performed in only two countries, South Africa and Egypt [3]. Consequently, much less is known about the clinical challenges of diagnosing and treating cancer in sub-Saharan Africa compared with many other regions around the world.

Racial and ethnic differences are known to contribute to cancer risk, incidence, and survival outcomes. Yet many innovations in cancer medicine (i.e., chemotherapies, diagnostic advancements, treatment protocols, etc.) have not been evaluated in a sub-Saharan African setting. Inadequacies in the representation of diverse patient populations in cancer research and in clinical trials may compromise treatment outcomes when improper assumptions are made about safety and efficacy profiles.

More clinical research and clinical trials are needed to assess new and established cancer treatments in Africa and to better understand tumor genetics and biology across all African ethnicities. Many patients lack access to cancer medicines and treatment and clinical trials can serve to improve access for underrepresented and impoverished populations, where chemotherapy, radiotherapy, and/or surgery is largely cost-prohibitive.

Conducting clinical trials in sub-Saharan Africa: barriers and opportunities

Obstacles to conducting research in sub-Saharan Africa include limitations in institutional resources, complex patient recruitment and referral networks, and delays in the regulatory and ethical review processes. In 2017, BIO Ventures for Global Health (BVGH) launched the African Access Initiative (AAI) to complement efforts by African Ministries of Health to address these challenges and the growing burden of cancer in their countries. Through AAI, the African Consortium for Cancer Clinical Trials (AC3T) was created to build clinical trial capacity in Africa. AC3T empowers African scientists to conduct cancer research and clinical trials at their home institutions with highly-representative patient populations.

AC3T consists of a network of approximately 50 cancer centers across the continent that are committed to building clinical trial capacity and implementing cancer trials. The AC3T platform increases visibility of Africa’s current clinical trial sites, capabilities and priorities. The site profiles make it easy for industry, academia, government and nongovernmental organizations to efficiently identify clinical trial sites while streamlining and de-risking site selection due diligence.

In February 2021, BVGH launched the AAI Virtual Training Series for Cancer Clinical Trials. The 14-week training program attracted 439 registrants from 37 countries. Each week focused on a different topic including: the drug development process; clinical trial basics; phase I, II, III, and IV clinical trials; principles of good clinical practice; protocol design and statistical methods; research ethics; patient recruitment; cross-sector perspectives and practices; budgeting for clinical trials; imaging for clinical trials; patient communication; and writing competitive grant applications.

Outcomes and impact of the AAI Virtual Training Series for Cancer Clinical Trials

The AAI Virtual Training Series for Cancer Clinical Trials was attended by participants from 37 countries including Algeria, Australia, Botswana, Burkina Faso, Cameroon, Canada, Côte d’Ivoire, Egypt, Eswatini, Ethiopia, Germany, Ghana, Iraq, Jordan, Kenya, Malawi, Morocco, Mozambique, Namibia, Niger, Nigeria, the Democratic Republic of Congo, Romania, Rwanda, Saudi Arabia, Senegal, South Africa, Spain, Sudan, Tanzania, Togo, Tunisia, Uganda, the United Kingdom, the United States, Zambia, and Zimbabwe. Course participants attended 14 consecutive weeks of live, interactive lectures for a total of 21 training hours. The lectures included moderated discussions with world-renowned cancer experts from leading institutions, including Takeda Pharmaceuticals, Harvard University, the University of Oxford, the South African Society of Medical Oncology, University of Nigeria Teaching Hospital, University of Chicago, Muhimbili University of Health and Allied Sciences, and the National Institutes of Health.

Course certificates were awarded to 200 of the program participants that attended all 14 sessions, submitted weekly homework assignments and completed a pre- and post-course survey and assessment. Analysis of the pre-, mid-, and post-course assessments indicated that more than half of the participants (63%) demonstrated a marked improvement in their knowledge of clinical trials; an average increase of 22% from pre- to postcourse assessment. Feedback from participants on the impact of the program was overwhelmingly positive:

"Every aspect of this course – from the management to the array of speakers and topics – was highly organized, informative, and rewarding. Clinical trials now seem possible and worthwhile.” - Nazima Dharsee, Ocean Road Cancer Institute, Tanzania
“The educator’s knowledge and expertise in this field made once-complicated concepts of clinical trials radically simple. Asanta Sana!” (Swahili translation of “thank you very much.”) - Gloria Kitur, International Cancer Institute, Kenya

The graduation ceremony was attended by guest speakers Julie Gralow, Executive Vice President and Chief Medical Officer of the American Society for Clinical Oncology (ASCO), Chris Reddick, Vice President and Head of R&D Health Equity at Takeda Pharmaceuticals, Wil Ngwa, Director of the Global Health Catalyst at Brigham and Women’s Hospital and Assistant Professor of Radiation Oncology at Harvard Medical School, and Jennifer Dent, President and CEO of BIO Ventures for Global Health.

"Building capacity and conducting cancer clinical trials in Africa is essential. I am deeply committed to working with BVGH to develop and implement clinical research programs that address Africa’s priorities and ensure patients receive evidence-based treatment by trained clinicians.” - Julie Gralow, Executive Vice President and Chief Medical Officer of the American Society for Clinical Oncology (ASCO)
“This [the AAI Virtual Training Series for Cancer Clinical Trials] is truly a special – and timely – program given the important role that clinical research is playing in addressing many of the challenges in our world right now. At Takeda, we have been long-term partners of BVGH and its efforts to strengthen clinical trial capacity in Africa. Clinical trials are important for patients and communities and help provide access to care, access to new medicines for patients, generate new data to solve healthcare challenges, and help to strengthen healthcare systems in communities and countries broadly.” - Chris Reddick, Vice President and Head of R&D Health Equity at Takeda Pharmaceuticals

Following the success of the AAI Virtual Training Series for Cancer Clinical Trials, BVGH announced the AC3T Study Pool Mini-Grant to support early- and mid-career African healthcare professionals graduating from the course. The MiniGrants are intended to prepare awardees to apply for larger, externally funded grants and participate in multi-site cancer research studies and clinical trials.

Awardees will have the opportunity to be paired with an external African or international cancer research expert who will mentor the awardee over the duration of the funded research project. Applications will be considered based on the scope of the study, intent to publish and/or present the results of the research project, approval and support from hospital leadership, and the awardee’s intent to integrate the research into his/her career. Awards will be announced in October 2021.

The AC3T Study Pool Mini-Grant complements the AC3T online platform, an interactive tool designed and built by BVGH to profile and promote clinical trial capacity across participating African healthcare institutions. In addition to increasing visibility of clinical trial sites in Africa, the online platform supports African scientists to approach and connect with external investigators for joint clinical research.

AC3T is sponsored by Takeda Pharmaceuticals.

https://gco.iarc.fr/tomorrow/graphiclinetype=1&population=900&mode=population&sex=0&cancer=39&age_group=value&apc_male=0&apc_female=0#collapsegroup-0-0

2 https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21551

3 https://clinicaltrials.gov/ct2/results/map?cond=cancer&map=AF