ASCEND Project was a collaborative project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), which involved seven (7) different consortium members from Tanzania Mainland, Zanzibar and the United Kingdom. The consortium members were: Tanzania Medicines and Medical Devices Authority (TMDA), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), The Good Samaritan Foundation, Kilimanjaro Christian Medical Centre (GSFKCMC), The University Court of the University of St Andrews (USTAN), Zanzibar Food and Drug Agency (ZFDA), Zanzibar Health Research Institute (ZAHRI. Tanzania Medicines and Medical Devices Authority (TMDA) was the leading organization that coordinated the ASCEND Project with Dr. Adam Fimbo as a Principal Investigator. The project was implemented for 38th months from 1st November to 30th December 2023.

Project Objectives

Main Objectives

To advance Tanzania’s clinical research oversight and pharmacovigilance capacities to meet 21st-century challenges in research and development, public health emergencies and healthcare.

Specific Objectives

1. To increase efficiency and quality of reviews and inspections of clinical trials conducted in Tanzania.
2. To increase community awareness of research ethics and ADRs reporting.
3. To build the capacity of the Zanzibar National Health Research Ethics Committee and the Food and Drug Authority.
4. To adopt, domesticate and implement the AVAREF guidelines for clinical trials oversight.
5. To increase north-south and south-south experience sharing and harmonisation through networking.
6. To improve the capacity of TMDA-MUHAS RCORE for medicines evaluation and registration.

The project implemented different deliverables through different work packages, and the most significant achievements of the project by Tanzania Medicines and Medical Devices Authority (TMDA) include: -

1. Domestication and implementation of AVAREF guidelines.
2. Development of an electronic system for submission and review of clinical trial applications.
3. Training researchers on advocacy on laws, regulations and ethical issues pertaining to clinical trials.
4. Establishment of a Pharmacovigilance community engagement Model to work with TMDA, NIMR, and KCRI, and use the model to conduct community sensitization in the Dodoma region and Zanzibar.
5. Publication on “Lessons learnt from ASCEND project” open access: published 12th August 2024, Volume 21, article number 54,(2024): “Lessons from enriching Tanzania’s clinical research ethics, clinical trial oversight and Pharmacovigilance through ASCEND project”