Baseline Assessments

BASELINE ASSESSMENT ON THE CLINICAL TRIALS LANDSCAPE IN BOTSWANA

With the increase in the multi-disciplinary and collaborative clinical trials conducted in Botswana which challenges the capacity of regulatory authorities, it is imperative that an assessment of their capacities, functions, processes, and procedures be done so as to indicate areas of improvement. Hence, at the kick start of BoCTRe project, a Baseline Assessment was conducted. The Assessment was done by the technical experts from the National Health Research Authority (NHRA) Zambia and Tanzania Medicines and Medical Devices Authority (TMDA).

 

AIMS AND OBJECTIVES OF THE BASELINE ASSESSMENT

1. Assess current regulatory procedures and processes for approval and conduct of clinical trials at the NEC, NRA and IRBs:

-        collect information on registration (manual/electronic) and submission of clinical trials.

-        collect information on available guidelines, SOPs, policies and legislation documents available to guide implementation of clinical trials.

-        assess the review processes of clinical trials (by analyzing minutes, responses to investigators and documentation in place)

-        assess membership to NEC, NRA and IRBs in terms of qualifications and skills.

2. Assess capacity needs for clinical trials investigators:

-        Identify organizations conducting clinical trials in Botswana

-        Conduct inception meeting with institutions conducting clinical trials for project support.

-        Collect information on clinical trial investigators

-        Assessments of gaps and needs including visiting clinical trial sites.     

This weeklong activity saw the team travelling across the country visiting the National Ethics Committee, represented by the Health Research and Development Division in the Ministry of Health, National Regulatory Authority, (Pharmacovigilance Advisory Committee and Regulatory Officers represented by BoMRA, Institutional Review Boards and research institutions.

 

 

DOCUMENTS REVIEWED

At each site different documents were reviewed to assess and understand the systems. These included their regulations, guidelines, standard operating procedures, records, and other documentations. Apart from documentation, data was also collected by observation of systems, equipment and presence of personnel/staff and office premises.

CONCLUSION

The baseline assessment has revealed several strengths and opportunities within the Botswana health research system which the stakeholders can capitalize on to ensure improved systems that will translate in a robust and strengthened health research system.

 

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