The SMERT project ends in success

Funded by the European and Developing countries Clinical Trials Partnership (EDCTP), the two-year project brought together four institutions in Tanzania: National Institute of Medical Research (NIMR) through its Mbeya Medical Research Centre and National Health Research and Ethics Committee (NatHREC), Kilimanjaro Clinical Research

Institute – Kilimanjaro Christian University Medical College and Tanzania Medicines

and Medical Devises Authority (TMDA), supported by the University of St Andrews (UStAn) as the European partner.

The SMERT team met on 25th on September to prepare for the 2nd and last annual networking forum.

 

On the 26th, the annual networking forum was held at the TMDA headquarters bring together over 50 delegates including representatives of Institutional Research ethics Boards (IRBS) across Tanzania, regional centre of excellence for medicines regulation in Eastern Africa, directorate of vaccines and immunization, policy makers and stakeholders from various agencies in Tanzania. The theme of the forum was, “building Tanzania’s capacity for clinical research and pharmacovigilance”. The conference reflected on the achievements made by SMERT and chart the way forward.

 

 

By its name, SMERT aim was to Streamline health research ethics review and Medicines Regulation in Tanzania. This was achieved in the following ways:

1. Training to equip researchers and members of ethics committees in Tanzania with skills to effectively and timely assess the ethicality of research protocols. This would avoid unnecessary delays in approving research ethics applications and fake research being conducted in Tanzania.  As a result, the median time to approval of research protocols by Institutional Research Ethics boards (IRB) has reduced from 120 days to 32 days.  Bioethics curriculum at was established at Kilimanjaro Christian Medical University College (KCMUCo) to train all postgraduate medical and biological sciences students, and also for continuing professional education.  Two more Tanzanian Universities have adopted the curriculum for training their students.  Furthermore, a short ethics training course curriculum was developed and is hosted by NIMR and after accreditation, NIMR will make the course freely available online as a resource for refresher training of members of research and clinical trial ethics committees across Tanzania. UStAn supported the development of both curricula and Dr Wilber Sabiiti was invited to give a lecture on the ethics- of new frontiers in medical research and responding to public health emergencies to the first class at KCMUCo.

2.  Strengthening infrastructure and human resource for:

Rapid submission, review and feedback of research ethics applications to the NIMR headquarters through NatHREC. To this effect an electronic     system was developed through which research protocols will be submitted, reviewed and feedback given.

Rapid reporting on the safety of medicines and vaccines during clinical trials at TMDA. An electronic system was developed to this effect to expedite reporting of adverse drug events (ADEs) arising during the trial of new medicines. SMERT also supported the enhancement of the system for post registration medicines and increasing awareness of the importance of reporting ADEs by the community. As a result, ADE reporting quadrupled since 2019, the SMERT’s 2nd year of work.

Monitoring ethical conduct of health research and clinical trials of medicines and devices for both NIMR and TMDA. To increase efficiency and cost-effectiveness, joint monitoring visits of research were agreed between NIMR and TMDA.

3.  Harmonising health research ethics review and medicines regulation in the East African community. SMERT achievements on research ethics review will feed into the East African Health Research Commission’s work to harmonise the research ethics review across the East African Community. Through SMERT support, TMDA spearheaded and hosted a forum by all national medicines regulatory bodies to discuss ways for harmonising medicines regulation guidelines across East Africa.

 

The SMERT team held a post-forum meeting on 27th September to discuss the next steps after SMERT phase I.

We believe the long-term impact of SMERT is protecting the people of Tanzania from participating in dangerous research and being tried on with unsafe medicines. Secondly, research participants who get adverse drug reactions during clinical trials will be given the right care within the shortest possible time.