EDCTP SPONSORED BERC-AFRICA WORK PACKAGE 3: TRAINING ON ESSENTIALS OF CLINICAL TRIALS

As part of the capacity-building activities under Work Package 3 of the Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) project, two officers of the Clinical Trials Department at the Food and Drugs Authority (FDA), Jesse Kojo Kuntoh and Pearl Entsua-Mensah, were nominated to attend a course on Essentials of Clinical Trials. The BERC-Africa Project is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP).

The training which was organized by the London School of Hygiene and Tropical Medicine and planned for Year 3 of the Project came off as scheduled. Activities under Work Package 3 of the project are geared towards capacity-building activities necessary for the professional development of FDA Officers who are RCORE trainers and assessors of clinical trial applications.

The Essentials of Clinical Trials Training is an intensive and comprehensive one-week course/programme which is designed to equip healthcare professionals, researchers, and individuals involved in clinical research with the fundamental knowledge and skills essential for the successful planning, execution, and evaluation of clinical trials. Clinical trials are pivotal and indispensable in advancing medical knowledge, informing evidence-based practice, and ensuring the safety and efficacy of healthcare interventions. Students were expected to understand the common pitfalls associated with study designs, be able to choose the most appropriate type of trials and ensure that the data churned out of such trials is credible. This training therefore serves as a cornerstone in fostering a deep understanding of the intricacies and ethical considerations surrounding clinical trials.

The two nominees from Ghana FDA took part in the training from 3rd to 7th July 2023. The training was virtual and took the form of theoretical sessions delivered through PowerPoint presentations and hands-on practicals/assignments in the form of group breakout sessions and discussions. There was an overall course evaluation on the last day of the training. This enabled participants to make some recommendations to enhance future training.

At the end of the course, the training provided a holistic understanding of clinical trials, encompassing both theoretical and practical aspects. Participants were exposed to diverse trial designs and the global perspectives broadened the officers' outlook on clinical trial methodologies which is essential in the understanding and discharge of their duties.

Jesse Kojo Kuntoh, a regulator at Ghana FDA and participant in the July 2023 Essentials of Clinical Trials Training organized by LSHTM, a training funded by the EDCTP-under the BERC-Africa Project.

Pearl Entsua-Mensah, a regulator at Ghana FDA and participant in the July 2023 Essentials of Clinical Trials Training organized by LSHTM, a training funded by the EDCTP-under the BERC-Africa Project.