Botswana Clinical Trials Regulation (BoCTRe)

There has been an increase in health research that put a demand for ethics review and regulatory approval of clinical trials in Botswana. Botswana is experiencing a significant increase in volume and complexity of clinical trials seeking approval.

These require quality scientific and ethical review by the National Ethics Committee (NEC), Institutional Review Boards (IRBs) and NRA. An effective and efficient National Medicines Regulatory Authority (BoMRA) is essential.

However, Botswana has limited capacity in terms of human resources, finance, infrastructure and an electronic document management system.

Through the Botswana Clinical Trial Regulation (BoCTRe) project, the NEC and NRA (BoMRA) intends to build capacity by focusing on internationally defined regulatory strengthening initiatives.

The objective of this grant is to build capacity of the NEC (Health Research and Development Committee), affiliated Institutional Review Boards (hospital based IRBs and University of Botswana), and NRA (BoMRA) to establish strong regulatory procedures. This is an essential foundation for conducting quality clinical trials in Botswana.

Zambia (National Health Research Authority) and RCORE Tanzania Medicines and Medical Devices Authority (TMDA) will be engaged to provide expertise in the baseline assessment, review and development of SOPs, and assist in development and implementation of training materials.

TMDA has established efficient, streamlined regulatory procedures as evidenced by reaching the WHO Maturity Level 3 as assessed by the WHO Global Bench Marking of regulators.

By providing training, SOPs and educational materials to the NEC and NRA, they will significantly contribute to the strengthening of clinical trial regulatory capacity in Botswana.

This project involves building a sustainable partnership between the NEC (HRDC) and NRA (BoMRA) and external partnerships that can support NEC and NRA initiatives in clinical trials oversight.

The expected outcome of the BoCTRe project is strengthened NEC and NRA capacities, better qualified personnel and more efficient, effective and harmonised regulatory pathways for clinical trials evaluation and monitoring.

The objectives of the BoCTRe project are: To conduct a baseline assessment of clinical trials capacity for the NEC, IRBs and NRA in terms of: Clinical trials approval and Inspection Processes and Procedures. Skills and competencies of the NEC, IRBs, clinical investigators and NRA. Electronic data management system for efficient submission, review and response. 2.

To build capacity of the NEC, IRBs, NRA and investigators. 3. To promote regional networking and benchmarking on best practices. 4. To address emerging clinical trials components, such as, genomics, bio-banking, medical equipment and devices. 5. To develop an electronic system to improve efficiency.