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Mrs Tebogo

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With an increase in health research, there is a greater need for ethics evaluation and regulatory oversight of clinical trials worldwide. Botswana is seeing a surge in the number and complexity of clinical studies/trials seeking approval. These trail protocols need thorough scientific and ethical examination by the National Ethics Committee (NEC), Institutional Review Boards (IRBs), and the National Regulatory Authority (NRA) to ensure the rights and wellbeing of study participants. Effective regulatory mechanisms are a prerequisite for conducting high-quality clinical studies.

That is why the Botswana Clinical Trials Regulation (BoCTRe) project came to be. The project is a joint initiative of BoMRA (NRA) and Health Research and Development Committee (HRDC), MoHW. NRA (BoMRA) and National Ethics Committee (HRDC), through this project, seek to build capacity by focusing on globally specified regulatory strengthening initiatives. The goal of BoCTRe project is to strengthen the HRDC, affiliated Institutional Review Boards (hospital-based IRBs) and NRA in order to build effective regulatory mechanisms.

This project entails developing a long-term partnership between the NEC (HRDC) and the NRA (BoMRA), as well as external partnerships to assist NEC and NRA initiatives in clinical trials oversight. The BoCTRe project is projected to result in stronger NEC and NRA capacities, more qualified personnel, and more efficient, effective, and harmonised regulatory routes for clinical trial review and monitoring.

Zambia's National Health Research Authority (NHRA) and RCORE Tanzania Medicines and Medical Devices Authority (TMDA) were engaged for assistance in the baseline assessment on clinical trials topography in the country, review and creation of SOPs, as well as assistance in the development and implementation of training materials for capacity building.

In the end the BoCTRe Project aims to achieve a sstrengthened, functional, and performing NEC and affiliated IRBs. Furthermore, Botswana will have a stronger National Ethics Committee (NEC) and National Regulatory Authority to ensure effective clinical trial regulation in Botswana. The electronic submission system, will allow for online protocol submission, tracking, and evaluation, increasing efficiency. The NEC and NRA will have effective processes in place to regulate clinical trials and will be expected to collaborate. The project facilitates regional networking via the Regional Centres of Excellence that will assist the NEC and NRA.

The project also aims to build systems, processes, and procedures. SOPs that have been reviewed and established in accordance with international standards will ensure productive and uniform evaluations. There will also be greater human capacity and capabilities for both NEC and NRA members as they learn the specialized skills necessary for clinical trial evaluation & approval, audits, and inspections of clinical trials. In essence, this grant will protect the safety, rights, and well-being of trial participants. The improved quality of the data generated will increase the trust of clinical research organizations and sponsors in coming to Botswana to conduct research. The NEC and NRA are expected to be on par with other Regional Centers by the conclusion of the grant's execution. All of this will help the initiative to accomplish SDG 3: 'Ensure healthy lives and promote well-being for all at all ages’.