SPaRCS Strengthening Clinical Trials Oversight Workshop

The SPaRCS Clinical Trials Oversight Workshop was held 9-12 October 2022 at Victoria Falls, Zimbabwe and hosted by the Medicines Control Authority of Zimbabwe. The workshop focused on Clinical Trials Oversight, the second mutual learning thematic area within the Strengthening Pharmacovigilance and Regulatory Capacities in four Southern African countries (SPaRCS) Project. Twenty-three participants from six countries (Eswatini, Namibia, South Africa, Zimbabwe, Botswana, and Belgium) attended the workshop which was led by SPaRCS team members Mr Star Khoza, Mr Liberty Chirinda and Ms Anna Shimbulu.

The workshop objectives were to:

• increase collaboration and networking between national regulatory authorities (NRAs) and national ethical committees (NECs) on the regulation of clinical trials
• identify areas of good practice in the regulation of clinical trials
• describe challenges and opportunities for improvement of the current clinical trial regulation environment
• develop an action plan towards development of a framework for clinical trial oversight and regulation within the four countries

The workshop brought together participants from National Regulatory Authorities (NRAs), National Ethics Committees (NECs) and researchers; as one initiative aimed at increasing collaboration and building on the efforts which have already been undertaken to address the improvement of oversight of clinical trials (CTs) in the region.

The workshop commenced with a presentation on the basis for regulation of clinical trials and explored examples of historical and recent violations leading to the development of various codes and guidelines including the ICH Guidelines for Good Clinical Practice (GCP), highlighting the importance of clinical trials registration. Discussion amongst participants raised issues of whether there can be harmonisation; autonomy; collaboration on CT registration; the links to ZaZiBoNa; and managing geopolitical interests. Presentations of the NRAs and NECs roles and activities in the four SPaRCS countries – Namibia, Eswatini, South Africa and Zimbabwe – described the varying structures, roles and experiences, as well as examples of good practice and current challenges in these areas.

A researcher’s perspective on challenges and opportunities of conducting clinical trials in the region emphasised the following issues: timelines; different bodies and duplication of roles; shipment approvals; clarification of guidelines and Standing Operating Procedures (SOPs); regional harmonization; possibilities for a regional dashboard, central lab for region, and training. An electronic submission and communication system used in the UK was presented as a useful option.

The challenges of meeting the requirements of NEC and NRAs was described. These included the capacity of NRAs and NECs to follow up on serious adverse events (SAEs) and the challenge around implicit reliance on drug safety monitoring board (DSMB) reports by NECs and NRAs.  Opportunities for the way forward included standardization of procedures; and capacity strengthening.

An ideal clinical regulation environment was presented, however, whether we need to make ethical principles more relevant to our context was a key point discussed. It was noted that the clinical trials environment is complex and the work of the African Vaccine Regulatory Forum (AVAREF) has been useful in this regard especially during the recent COVID-19 pandemic. However, building further capacity in Africa in clinical trials is critical. The advances made in a neighbouring country demonstrated how it is possible to make strides towards collaboration between the NRA and NEC with practical steps which include the use of mid-level workers.

Challenges for conducting clinical trials in southern Africa and the clinical trials regulatory environment were discussed in detail and possible solutions were posed. It was recommended that a framework for effective clinical trial oversight should include advocacy with other institutions, harmonisation, upskilling of human resources and an increase in funding.

Five SPaRCS team members remained in Harare for two further days after the workshop to take part in a mutual learning exchange/site visits.  The team visited the Medicines Control Authority of Zimbabwe (MCAZ) and Medical Research Council of Zimbabwe (MRCZ) offices and held meetings with relevant officials and also observed a GCP inspection.

For more information on the workshop or the project and follow-up activities please contact Hazel Bradley or Star Khoza

Acknowledgements:

The SPaRCS project is part of the EDCTP2 programme supported by the European Union (grant number CSA2018ERC-2332-SPaRCS)