Cancer research provides the way through which cancer care improved in HICs (Barrios et al. 2018). Through research, effective methods of diagnosis and treatment relevant to the population are being identified, developed, and put into practice.
The problem: There is a low level of research in most LMICs. Little is budgeted for research leading to a low impact of research on cancer care. Research activities covering the assessment of the current status of cancer incidence (registries), clinical research with a focus on the population served, and behavioral research for the improvement of primary and secondary prevention are required for effective cancer control in LMICs.
Possible solutions: One way of improving this is to form research collaborative groups involving researchers from LMICs and those from HICs. This will enable the researchers from LMICs to be mentored by researchers from HICs. Such collaborations should focus on identifying common malignancies where obvious improvements can be demonstrated. Senior and junior researchers should be involved in such collaborations, and each team should inculcate research methods, particularly good research practice and good governance, as well as generation of research ideas in LMIC members. There is also the need to improve funding for research to local researchers in LMICs so that they can build their research teams and improve facilities that will enhance research collaborations.
Clinical trials provide the main process by which new drugs are introduced into clinical care. There is a need to study individual drugs in target populations to ascertain activity and toxicity in populations because there might be ethnic differences in drug response.
Problem: Less than 2% of global clinical trials in oncology are conducted in sub-Saharan Africa.
In Nigeria, less than five oncology-related clinical trials have been conducted so far based on our search through major clinical trial registration websites. It is also noted that none of the antineoplastic drugs currently in use in Nigeria included indigenous participants in the trial that led to the approval of such agents for use in humans. This implies that the pattern of activity and toxicity of such agents on our population is unknown bearing with it risks for poorer performance and hence poorer acceptance of these drugs.
Solutions: There is a need for collaboration between researchers in HICs with LICs to improve expertise, infrastructure, and support for clinical trials that will involve indigenous populations. All experimentation involving humans must be held to the highest standards, and all principles of good clinical practice must be observed. This is achieved easiest when physicians learn the proper conduct of clinical trials from the best in their fields.
To improve this in Ibadan, we partnered with the University of Chicago, USA, building on a long-standing research collaboration, to improve oncology clinical trials in Nigeria. At the initial survey, there was low capacity of the personnel on the conduct of clinical trials as most of them never took part in a clinical trial before. There were no study monitors conversant with oncology clinical trials to provide regular monitoring of trials to ensure protocol and GCP compliance. There were regulatory bodies in place such as the institutional review boards (IRBs) and the Nigerian national regulatory body—the National Agency for Food and Drug Administration and Control (NAFDAC), but these bodies had limited experience in regulating oncology-related clinical trials. At the institutional levels, there was little experience on the part of the management team on the review and administration of oncology clinical trial contracts. There were also some inadequacies in clinical facilities to support oncology-related trials.
Personnel on all aspects of clinical trial were trained in good clinical practice and relevant areas on Nigerian regulations with respect to clinical trials. The facilitators included personnel from the University of Ibadan, Nigeria, the University of Chicago, and the Roche Pharmaceutical Company. The trained personnel included clinicians, pathologists, radiologists, pharmacists, study coordinators, psycho-oncologists, study nurses, statisticians, data managers, and patient navigators. There were no study monitors and study manager at our center, so six study monitors and one study manager were trained with the assistance of a clinical research organization (CRO) from the USA. During the training, the clinical personnel were able to develop standard operating procedures (SOPs) for their various services. Four centers in Nigeria, which had prior research collaborations with the University of Chicago, were involved in the project. Further details on preparing the sites for clinical trials were captured in our previous report (Ntekim et al. 2020).
To test run our oncology clinical research teams, the University of Chicago sponsored the phase II ARETTA study (ClinicalTrials.gov NCT03879577) to ensure the study teams can deliver. The study is ongoing as at the time of this report under the supervision of the University of Chicago.
There is scarcity of insurance companies in Nigeria with experience in underwriting oncology clinical trials. Therefore, this service was procured in the USA by the University of Chicago. We have, however, identified few indigenous companies in the meantime that have affiliations with US companies capable of providing this service.
Participants’ engagement was an issue during the implementation of this trial. Most of the potential participants were not aware of the importance of clinical trials. Enlightenment campaigns were carried out among care groups and nongovernmental organizations to sensitize the populace on clinical trials. This paid off as we were able to enlist the support of these groups thereby improving study accrual.