A cancer trial can have an approved protocol, a trained team and medicine ready to dispense, yet remain out of reach for a patient waiting for a pathology result. Before an investigator can assess eligibility, someone must obtain an adequate sample, establish the diagnosis and complete the tests that guide the next decision.
That interval deserves as much attention as the trial’s recruitment target. It connects the scientific promise of oncology research to the practical conditions under which patients can participate.
The International Agency for Research on Cancer estimates that Africa recorded approximately 1.2 million new cancer cases and 727,000 cancer deaths in 2024 (1). Behind those continental figures are different national health systems, referral pathways and diagnostic resources. Oncology research must be designed around those differences without compromising scientific or ethical standards.
The central question is therefore not simply how many trial sites Africa can open. It is whether the diagnostic and care pathways around those sites can support reliable decisions, safe treatment and meaningful follow-up.
A diagnostic result must be accurate, timely and usable
In biomarker-selected trials, eligibility may depend on a molecular or protein characteristic of the cancer, not only its anatomical location. Testing requires suitable samples, and insufficient tumor tissue can prevent an informative result (2). Depending on the protocol, pathology review and staging investigations must also be completed before treatment can begin.
These requirements make the entire diagnostic process part of trial readiness. A laboratory’s ability to perform a test is not enough if specimens arrive late, results are not returned to the treating team or the patient cannot reach the next appointment.
Experience from Rwanda illustrates the importance of organizing that process. A retrospective study at the Butaro Cancer Center of Excellence compared three diagnostic approaches during the development of its pathology service. Median time from biopsy to a finalized report was 30 days when samples were sent abroad, 14 days with static-image telepathology and five days with on-site expert diagnosis (3).
Those historical findings are not a performance benchmark for every setting. They demonstrate something more useful: diagnostic turnaround is shaped by how expertise, specimen processing and reporting are connected.
For trial planning, the implication is clear. Feasibility should establish how a sample becomes a clinically usable result, who is responsible at each handover and what happens when the process fails. Investment in sophisticated testing should not come at the expense of dependable tissue collection, routine pathology and quality assurance.
Feasibility belongs to the whole care pathway
The World Health Organization’s guidance on early cancer diagnosis connects diagnostic and referral capacity with access to timely treatment (4). The same logic should inform oncology trial design.
A research unit may be well equipped while a service essential to its protocol sits elsewhere. Surgery, radiotherapy, blood products, infection management or emergency admission may depend on another institution. Where those services are required, feasibility must establish that participants can actually obtain them, within the necessary time and without unresolved financial barriers.
The practical questions are specific. Who books the referral? Who pays for the investigation? How will urgent care be arranged after hours? Can imaging be repeated consistently enough to assess treatment response? Who follows up when a participant misses a visit?
Recognizing local constraints must not become a justification for weaker protection. Comparator selection requires scientific and ethical justification, not merely a description of what is routinely available. The Declaration of Helsinki sets the best proven intervention as the default comparison, with narrowly defined exceptions (5).
The appropriate response to a service gap is to address it before enrollment, select a scientifically appropriate study that the pathway can support or defer participation until the requirements can be met.
Distinguish biological ineligibility from a failed pathway
A patient whose cancer lacks a required biomarker is different from a patient whose biomarker status was never established because testing could not be completed. Both may be absent from the enrolled population, but they reveal different things about a research program.
That distinction matters when interpreting recruitment difficulties. A low enrollment rate may reflect the disease characteristics a protocol is designed to study. It may also reflect delayed referrals, inadequate specimens, unaffordable travel or results that never reach the clinical team. These possibilities should be investigated rather than assumed.
Research networks should therefore measure more than enrollment totals. Diagnostic turnaround, inadequate-sample rates, incomplete staging, reasons for screening failure and losses between referral and enrollment can show where the pathway needs attention.
Where access barriers systematically affect who reaches screening, the enrolled population may be narrower than the population the findings are intended to inform. Understanding that limitation is part of scientific credibility. It also helps sponsors and investigators direct investment toward the actual constraint rather than responding to every recruitment problem by opening another site.
Regional networks need operating agreements, not just equipment
Not every institution needs its own advanced molecular laboratory or every specialist service. A regional model can concentrate selected functions while connecting participating hospitals through reliable specimen, reporting and referral arrangements.
But a network is not established by naming a reference laboratory. It needs agreed turnaround expectations, specimen acceptance criteria, quality checks and a route for resolving uncertain or conflicting findings. Where samples cross borders, applicable permissions, consent and logistics must be addressed in advance. Clinically relevant results need a defined route back to the treating team and patient.
The financing must be equally deliberate. Sponsors should budget for the diagnostic work and coordination their protocols require, including screening that does not lead to enrollment. Institutions and public-sector partners should agree how shared services will be staffed, supplied and maintained between studies.
This is where trial investment can strengthen care without pretending to replace health-system financing. Equipment may support several studies and routine services, but only if there is an operating budget and clear responsibility for its continued use. Research activity should not leave routine patients facing longer queues because scarce staff and laboratory time have been diverted without additional support.
Plan for the participant beyond the protocol
Durability also has a clinical meaning. Participants need to know who will manage their care if they are ineligible, withdraw, experience disease progression or complete trial treatment.
Post-trial arrangements should be considered before recruitment, not negotiated at closure. The 2024 Declaration of Helsinki requires advance provisions for participants who still need an intervention identified as beneficial and reasonably safe in the trial, with any exceptions approved by a research ethics committee and the arrangements disclosed during informed consent (5).
For ACRN, this is the standard that should guide oncology research development: assess readiness across diagnosis, treatment and follow-up, and pursue shared infrastructure that remains useful beyond an individual protocol. The priority is not to place every technology at every site. It is to make the necessary expertise and services reliably accessible.
Africa’s oncology research ambitions should be judged by more than the number of sites activated. A stronger measure is whether a patient can move from a suspected cancer to a reliable diagnosis, an appropriate research decision and continuity of care. When that pathway works, research capacity and diagnostic capacity are no longer separate investments. They are parts of the same credible system.
References
- International Agency for Research on Cancer. Africa: GLOBOCAN 2024 fact sheet. Lyon, France: International Agency for Research on Cancer 2026.
- National Cancer Institute. Biomarker testing for cancer treatment Bethesda, MD: National Institutes of Health; 2021 Available from: https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment.
- Muvugabigwi G, Nshimiyimana I, Greenberg L, Hakizimana E, Ruhangaza D, Benewe O, et al. Decreasing Histology Turnaround Time Through Stepwise Innovation and Capacity Building in Rwanda. Journal of Global Oncology. 2017(4):1–6.
- World Health Organization. Guide to cancer early diagnosis. Geneva: World Health Organization; 2017.
- World Medical Association. Declaration of Helsinki: ethical Principles for medical research involving human subjects 2024 [2024 revision] Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki/.