During the site assessment visits, deficiencies were noted and plans were made to address them to ensure the sites were prepared to participate in clinical trials. After completion of the initial site assessment visit of all four local institutions, the following Infrastructural deficits were identified (Table 1)
Clinical evaluation, laboratory and imaging studies
All four centers had basic functioning apparatus to measure vital signs such as thermometers for body temperature, blood pressure (BP) apparatus, weighing scales and height measurement but there were no regular yearly calibrations and maintenance of these items at any of the sites.
Two out of the four centers had standard blood investigation laboratories with Standard Operative Procedures, regular quality assurance checks, equipment maintenance logs and participation in international certification programs. The four centers had well-established pathology departments and services but there were issues of equipment malfunction or lack of reagents for certain investigations such as immunohistochemistry in some of the pathology laboratories. Facilities for pharmacokinetic studies were available at all four centers with qualified personnel. However, there were different inventories of analytic equipment such as spectrophotometer and high-performance liquid chromatography (HPLC) equipment across the centers. Ultrasound equipment and echocardiogram machines were available at all four centers, but none had evidence of yearly maintenance checks. Functioning CT scan machines were available at two of the four centers. The other two centers had broken CT scan equipment, although there were plans to repair it.
Oncology nursing staff and chemotherapy facilities
All four centers had oncology nurses, although few in number; and none had prior experience with clinical trials. There were dedicated chemotherapy administration rooms in only two centers. All the centers had emergency and resuscitation facilities but with incomplete inventories and lack of regular stock checks of items. Quality of life assessment services were available in one center, though they were not routinely offered to regular cancer patients. Chemotherapy preparatory facilities with biosafety hoods were lacking in all centers visited. There were no infusion pumps for chemotherapy delivery in any of the centers.
Pharmacy personnel, drug procurement and management of drug inventories
Only one center had an oncology pharmacist with experience in oncology drug preparation, drug accountability, drug storage, inventory and maintenance of logs. Standard investigational medical products (IMPs) storage facilities were available in one center; however there was no alarm system notifying staff about change in temperature in cold chain therapies. This was however, manually done by performing regular checks even during non-office hours. There was no special procedure for disposal of remnants of oncology drugs at any of the centers. These were handled in the same manner as other hospital waste.
Skills of local investigators and clinical trial staff
Skills were assessed based on previous Good Clinical Practice (GCP) training and knowledge on safety reporting standards. Among the four centers, one investigator and two study coordinators had prior training in GCP. No other study personnel had GCP training but investigators from all the centers had training in the ethical conduct of research, including the handling of human subjects in clinical research. Administrative staff for trial administrative functions were lacking in all the centers. None of the centers had an experienced Trial Monitor capable of conducting internal monitoring of trial activities.
Data management processes and data monitoring
Two centers had facilities for clinical research documentation and data storage. Three centers had data management staff but none were trained to maintain trial records and other important clinical trial and IRB-related documents. Robust online data transmission facilities were lacking in two centers.
Storage of biospecimens
All the centers had facilities for the storage of biospecimens collected from clinical trials although some had only limited space. Standard SOPs were lacking in all the biospecimen storage facilities.
Institutional Review Boards
The four centers had well-constituted, active ethical review boards. They had good experience in monitoring non-oncology clinical trials. Given the dearth of oncology clinical trials in Nigeria, these boards’ expertise specific to this domain could not be assessed.
Standard operating procedures (SOPs)
SOPs were available only in the two standard clinical laboratories identified. The pathology laboratories of the four centers had SOPs for procedures, such as immunohistochemistry studies, sample storage and processing. Other service areas such as radiology, pharmacy, clinical services sections, including chemotherapy administration services and outpatient clinics, as well as the informed consent process, had no SOPs.
Following the identification of the infrastructural deficiencies, the University of Chicago led in providing and sourcing grants and in identifying partners that could help address the deficiencies. These were sourced from NIH through D43 and K43 grant awards, philanthropic funding from the Breast Cancer Research Foundation and collaborations with pharmaceutical industries such as Novartis and Roche Pharmaceutical. Using these resources, improvements in institutional capabilities and facilities were carried out in the following areas:
Training of personnel
Two investigators were trained in study protocol development and trial management and five pathologists were trained in accurate and standard tissue diagnosis, reporting, and associated laboratory procedures. Those trained also included two radiologists, three study coordinators, one counselor and an oncology pharmacist. These personnel were trained in the USA (Table 2). They returned to Nigeria to train others in their respective fields. These trained personnel then trained at least three personnel in their respective fields of specialization.
In addition, two local training workshops were conducted in Nigeria facilitated by staff from the University of Chicago and Roche Pharmaceutical Company. These training sessions were on Good Clinical Practice, ethics in clinical research and Standard Operative Procedure development. Sessions were well attended by members of the clinical trial teams from the four institutions. The training topics included steps and processes involved in conducting clinical trials, such as informed-consent, handling of IMPs, participants’ screening, recruitment and follow up. Other in-country training sessions were conducted for eight study monitors; two of these trainees were designated to serve as internal monitors while six functioned as external monitors for the clinical trial activities of the network.
Upgrade of facilities
In all four institutions, oncology drug storage, drug preparation room (clean room), biosafety cabinets and therapy administration facilities were established (Table 1). All four institutions supported these efforts by internally-sourcing funds to renovate and improve their respective cancer treatment units. There was also commitment to regular servicing and calibration of equipment used for patient care and clinical trial activities. The support and commitment in all institutions were facilitated by Key Opinion Leaders and Policy makers whose interest was to upgrade the ability of their respective institutions to conduct interventional cancer clinical trials as well as other kinds of trials that can ultimately improve the care of patients or has the tendency to expose patients to innovative interventions. The clinical trial capacity of the country particularly in these four indexed institutions is rising therefore there are local aspirations to be a part of the globalization of clinical trials. Pharmaceutical companies who have been excluding SSA populations from clinical trials citing poor infrastructure as the reason, can now start thinking of including African sites in their drug development programs. In comparison with conducting trials in the Western world, conducting trials in LMIC particularly in Nigeria would be cost effective at the same time having the potential of improving the healthcare system.