The project aims at strengthening the capacity of clinical trials research; ethics review frameworks and medicines regulatory bodies in Tanzania Mainland and Zanzibar and will be implemented for 30 months. The title of the project is “Moving Tanzania’s Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicine Quality, Safety and GCP Clinical Trials” with acronym of “ASCEND”.

Through the ASCEND consortia, ethics and medicines regulatory bodies in the United Republic of Tanzania: Tanzania Medicines and Devices Authority (TMDA), National Institute of Medical Research - National Health Research Ethics Committee, Zanzibar Food and Drug Authority and Zanzibar Health Research Ethics Committee will be Empowered and become efficient.

Zanzibar, has recently established its own national research ethics committee and medicines regulatory authority, which still require a lot of capacity building to research ethics committee and medicines regulatory authority. The two bodies still need to be equipped to effectively execute their mandates. Through ASCEND, ethics committee members and pharmacovigilance monitors will be trained and a mentoring scheme will be put in place to ensure sustainable capacity building beyond ASCEND project.

With reference to the previous SMERT PROJECT, progress was made in building capacity for health research ethics and medicines regulation through developing short ethics training courses across the country. However, challenges such as reduction of median time to approval resulted in continuous change of trained participants and hence, lack of sustainability. The ASCEND PROJECT, vows to ensure sustainability through conversion of these short ethics training courses into accredited online ethics course hosted and curated by the National Institute of Medical Research – National Health Research Ethics Committee (NIMR-NatHREC). Efforts will be made to ensure free access and alignment of the course with other online resources. The online course will enable wider access to research ethics knowledge; provide a resource for trainers especially for practitioners who prefer face-to-face learning, and for those who want to advance in bioethics careers. The course will be linked to the graduate bioethics curriculum which was developed by the Kilimanjaro Christian Medical University of College (KCMUCo).

A correlation exists between the SMERT PROJECT AND THE ASCEND, in terms of continuity in progress. ASCEND will streamline, operationalise and popularise the electronic systems (i.e., online systems for ethics review covering protocol submission, review and feedback at NIMR-NatHREC and the clinical trial adverse drug reactions/events (ADR/Es) at Tanzania Medicines & Medical Devices Authority (TMDA)) by training stakeholders on how to use them. ASCEND will strengthen the online system for submission of clinical trials protocol to TMDA and link these two systems (TMDA and NIMR-NatHREC) via information sharing.

Despite the progress made in assessing and approving research protocols, a huge challenge in monitoring compliance to ethics and good clinical practice (GCP) standards during research exists. Without further oversight, a risk of conducting research below required ethical and GCP standards is at large. The ASCEND targets to empower the TMDA - MUHAS Regional Centre of Regulatory Excellence (RCORE) through developing and operationalising short-courses, both for clinical trial inspectors and assessors. As a RCORE for medicines evaluation and registration, this course will benefit both Tanzania and other countries in East Africa and Africa at large.

The ASCEND consortium – a joint venture between:

• Seven (7) institutions:
  • Tanzania Medicines and Medical Devices Authority (TMDA) which is a leading institution in this project
  • National Institute for Medical Research (NIMR)
  • Muhimbili University of Health and Allied Sciences (MUHAS)
  • Kilimanjaro Clinical Research Institute (KCRI)
  • Zanzibar Food and Drug Agency (ZFDA)
  • Zanzibar Health and Research Institute (ZAHRI) and
  • St. Andrews University from Scotland, UK.