Clinical trial oversight in Zimbabwe: The journey
Aclinical trial is defined in the Medicines and Allied Substances Control Act [Chapter 15:03] as “A systematic study in human beings or animals in order to establish the efficacy of, or to discover or verify the effects or adverse reactions of medicines, and includes a study of the absorption, distribution, metabolism and excretion of medicines”.
All clinical trials conducted in Zimbabwe are regulated in terms of Part III of the Medicines and Allied
Substances Control Act [Chapter 15:03] and the Medicines and Allied Substances Control (General) Regulations, 1991.
(S.I. 150 of 1991). No person shall conduct a clinical trial of any medicine in Zimbabwe without the prior written authorisation of the Medicines Authority of Zimbabwe, granted with the approval of the Secretary of the Ministry of Health and Child Care. The requirements and guidance documents for clinical trial application are available on the MCAZ website.
Clinical trials conducted in Zimbabwe and history
The first clinical trial application to be processed by the MCAZ was received in July 1993 and it was refused due to safety concerns. The clinical trial aimed to investigate the effects of Povidone Iodine Intravenous Solution in HIV-infected patients. To date, 215 clinical trial applications have been received and out of the 215 applications, two were refused due to safety concerns, one was refused since the country had no intention to use the product under study and 212 clinical trial applications were approved.
The MCAZ receives and processes an average of 10 clinical trial applications per year. About 60 percent of the clinical trials processed in
Zimbabwe are phase 2 and 3, 10 percent are phase 1 and 30 percent are phase 4 clinical trials. As shown in figure 1 below, most of the clinical trials processed in Zimbabwe are for HIV prevention and management (52 percent), Cancer treatment (6 percent), Tuberculosis (5 percent) and other
diseases and conditions like pain and malnutrition (34 percent). Covid-19 clinical trials contributed 3 percent of the total clinical trials that have been received and processed by the MCAZ. Since the outbreak of the Covid-19
pandemic, the MCAZ has received and processed 7 clinical trials for Covid-19 products.
Positive experiences with regards to clinical trial regulation
The MCAZ has managed to regulate clinical trials in a transparent manner and has adhered to the 60 days' timelines for processing clinical trials. In 2019 the MCAZ launched an electronic-Clinical Trials application and registry system for researchers to submit their applications online. The e-Clinical trial system is accessible on MCAZ website.
This online system has increased efficiency and ease of doing business for both the internal staff and customers. Various guidelines such as Clinical Trial Applications Guidelines, Good Clinical Trial (GCP) guidelines and GCP inspections were also developed by the MCAZ and also adopted WHO African Vaccine Regulatory Forum (AVAREF) Clinical trial protocol evaluation templates and GCP inspection guides that are based on the European Union templates in line with WHO GBT Maturity Level 3 requirements.
The MCAZ was also designated by the New Partnership for African Development (NEPAD) and the African Regulatory Harmonization (AMRH) as a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials. As a result of this, the MCAZ through the Pharmacovigilance and Clinical Trials division designed an intensive course to build capacity and equip regional regulators in clinical trials and pharmacovigilance.
Fig 1. Distribution of clinical trials received according to disease
To date, the MCAZ has conducted several NRA and National Ethics Committee clinical trials regulatory capacity trainings including bench marking self-assessment for
countries such as Botswana, Eswatini, Lesotho, Uganda, Namibia, Gambia, Liberia and Sierra Leone.
The MCAZ was formally assessed by the WHO from the 16th to the 27th of
August of 2021, using the WHO Global Figure 2
Benchmarking Tool (GBT), for all its functions. The Global Benchmarking Tool represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems. MCAZ successfully obtained Maturity Level 3 for the Clinical Trial Function which implies that there is a stable, well-functioning and integrated
regulatory system for clinical trial oversight as illustrated in figure 2.
Timelines for clinical trials applications evaluation for approval, and challenges experienced
MCAZ prioritises processing of all clinical trial applications including protocol evaluation of clinical trials, and review by the Pharmacovigilance and Clinical Trials Committee within the agreed timelines (15 working days for emergency use investigational products such as Covid-19
vaccines, and 60 working days for other clinical trial applications.) The challenges experienced that resulted in some delays for some clinical trial applications were:
i. Some challenges posed by the
Covid-19 era ii. Failure by investigators to
provide adequate participant insurance and current Good Manufacturing Practice (cGMP) and pharmaceutical development of the investigational products documentation. iii. Inexperienced investigators failing to address queries raised by the MCAZ leading to delays in approvals of the applications.
GCP inspection non compliances by some clinical trials study sites perhaps due to some Covid-19 inherent challenges and/or complacence by some investigators during the Covid-19 era.
No person shall conduct a clinical trial of any medicine in Zimbabwe without the prior written authorisation of the Medicines Authority of Zimbabwe, granted with the approval of the Secretary of the Ministry of Health and Child Care.