PA-496 Bridging the gap: training needs assessment for clinical trials assessors and inspectors and implementation of targeted capacity building in Tanzania

BackgroundThe Covid-19 pandemic and other emerging diseases increased the need to conduct clinical trials (CTs) to investigate appropriate treatments or prevention measures. One of the main barriers for conducting CTs in Africa is delays in regulatory and ethics reviews. Furthermore, existence of inadequate regulatory inspections of CTs to evaluate the integrity of data submitted to health authorities, protect patient safety, and assess the adequacy of site/sponsor quality systems to achieve the same. To this end, the ASCEND project assessed the level of competency and training needs for evaluating clinical trial applications (CTAs) and conducting clinical inspections in Tanzania. Moreover, to recommend interventions to bridge the gap. MethodsA descriptive cross-sectional study was conducted from February to June 2021 using an online survey to collect information on training needs and competencies. The population was 130 respondents from research, regulatory and academic institutions. ResultsOut of 130 approached respondents, only 69.2% (90/130) participated. The most common qualification of the respondents was a master’s degree (59%). Bachelor degree and PhD holders stood at 21% and 20%, respectively. The findings indicated that 94% of the respondents needed training on assessment of clinical data, 92.2% on product quality, 92.6% on statistical data, and 81.2% on understanding and using the checklist for Good Clinical Practice (GCP) inspection.These findings were used to develop two accredited short courses 70-hours (7-credits) each. The courses were CTAs assessment and GCP inspection. Consequently, 2-weeks short courses were conducted. Pre- and Post- course tests were administered to assess the training impact.ConclusionA pool of proficient assessors is important for quality reviews of CTAs and in timelines reduction. The short courses conducted were successful, and increased a pool of competent assessors and GCP inspectors in Tanzania. For further strengthening the regulatory capacity, additional training is recommended.