The ASCEND project aims in Moving Tanzania’s Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicine Quality, Safety and GCP Clinical Trials. To achieve this aim, collaborative support is harnessed across seven (7) different consortium members from Tanzania Mainland, Zanzibar and United Kingdom.
Ascend Project is a collaborating project funded by European and Developing Countries Clinical Trials Partnership (EDCTP) which involves seven (7) different consortium members from Tanzania Mainland, Zanzibar and United Kingdom.
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:
To advance Tanzania’s clinical research oversight and pharmacovigilance capacities to meet 21st century challenges in research and development, public health emergencies and healthcare.
The ASCEND Project is conducted through seven work packages. Each of them are lead by a different partner from the consortium in collaboration with the other partners.
Work package (WP) 1: Capacity building needs in ethics review and clinical trials monitoring
Work package (WP) 2: Electronic Systems for ethics and Pharmacovigilance
Work package (WP) 3: Training
Work package (WP) 4: Pharmacovigilance community engagement and sensitization
Work package (WP) 5: Zanzibar Food and Drugs Agency (ZFDA) and Zanzibar Health Research Institute (ZAHRI) Ethics Committee capacity building
Work package (WP) 6: Networking
Work package (WP) 7: Project Management
|WPs||WP Title||Lead Institution|
|1||Capacity building needs in ethics review and clinical trials monitoring||TMDA|
|2||Electronic Systems for ethics and pharmacovigilance||NIMR|
|4||Pharmacovigilance community engagement and sensitization||TMDA|
|5||Zanzibar Food and Drugs Agency (ZFDA) and Zanzibar Health Research Institute (ZAHRI) Ethics Committee capacity building||ZAHRI|
WP 1, 4, 6 and 7
TMDA is the coordinator of the project, and hence, apart from the designated work packages, 1, 4, 6 and 7, the authority is also responsible for the management and lead role in assuring that all set objectives through the divided work packages are hence forth met by all members of the consortium.
In brief detail; the work packages aforementioned above, present the authority with the task of achieving capacity building needs in ethics review and clinical trials control by identifying areas with such need, and adoption, domestication and implementation of the AVAREF guidelines for review of clinical trials and GCP inspection. Furthermore, as a lead member, and under cooperation with the tasked institutes, TMDA is responsible for spearheading the engagement of the community towards pharmacovigilance and networking the ASCEND project using various programmes and schemes that would be collaborative and harmonised as stipulated above. These roles will be cooperated with various institutes as stipulated above.
As the lead of the project, TMDA is eventually responsible for the management of the project. All of these work packages will be aided by the objectives set for the project, and specific objectives designated towards tracking the performance and maintaining the validity and requisite of the project.
Electronic Systems for ethics and Pharmacovigilance
working under the directives of work packages 2, 4 and 6, NIMR holds the responsibility of operationalizing and sensitizing users on the electronic ethics review and adverse drug reaction reporting systems developed under the SMERT project, and operationalize the TMDA online clinical trial SAE reporting system. Furthermore, NIMR is tasked with the development of the electronic system for submission and review of clinical trial applications by TMDA, ZFDA and ZHRI. Establishment of linkages of electronic submissions of clinical trial applications between NIMR and TMDA will also be under their control.
The engagement of the community will also be a cooperative role undertaken by NIMR and TMDA. Advocating and sensitization on laws, regulations, ethical issues and the overall oversight on issues relating to clinical trials to researchers and health care workers will be a pursued platform towards achieving this role
|Leader||:||MUHAS & KCRI|
MUHAS is tasked with the responsibilities defined in work package 3, that includes development of training schemes and conducting training to the NMRA assessors. The package also descriptively categorises MUHAS in the cooperative role alongside various institutional packages
KCRI Sustaining the e-IRD system at KCMUCo is among the roles of KCRI, along with the training of facilitators from IRBs towards face-to-face lectures. KCRI will steam a collaborative approach towards developing bioethics curriculum into e-learning and implementing the course via online access to various universities. The short ethics course will also be digitised, whereas a schedule would be arranged for the purpose of conducting in-country training workshops in ethics for IRBs and national ethics committees.
Zanzibar Food and Drugs Agency (ZFDA) and Zanzibar Health Research Institute (ZAHRI) Ethics Committee capacity building
|Leader||:||ZFDA & ZAHRI|
ZFDA is tasked with a cooperative role under work package 5, alongside ZAHRI, that incorporates capacity building, education and training of Zanzibar clinical trial stake holders and cement awareness in pharmacovigilance. Developing an automated authorisation system would benefit the time frame related with approval of various processes, including submission and approval of clinical trials
ZAHRI, in collaboration with ZFDA under work package 5, is tasked with improving their efficiency and functioning capability by adopting the electronic systems for submission of applications for clinical trials and ethics review. This would include operationalizing the adopted electronic system for reporting SAEs. The institute is also tasked with certifying and accrediting IRB bodies, while adhering to international standards and the AVAREF guidelines. The cooperative role will be wide spread to a range incorporating the networking activities lead by TMDA under work package 6
|Project Title:||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”.|
Project Coordinator: Mr. Adam M. Fimbo, Tanzania Medicines and Medical Devices Authority (TMDA) United Republic of Tanzania
Project start date: 01st November, 2020
Duration: 30 months
|Collaborative Institutions:||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.|
EDCTP grant amount: EUR 498,750.00
Funding Organization: EDCTP
The project started early November 2020, our archievements so far are:-
|WP #||Deliverable #||Deliverable Name||Lead||Year 1||Year 2||Year 3|
|1||1.1||Ethics Committee approvals||TMDA|
|1.2||Training Needs Assessment report (highlighting areas needed for training and capacity building), including copy of questionnaire and full details of response rates.||TMDA|
|1.3||Domestication and implementation of AVAREF guidelines (copies of adopted guidelines and evidence of implementation)||TMDA|
|2||2.1||Operationalisation of electronic ethics review (NIMR) and online clinical trial SAE reporting system (for TMDA)||NIMR|
|2.2||Electronic system for submission and review of clinical trials applications (for TMDA): report on number of proposals submitted and review process, and summary report on the functioning of the system||TMDA|
|2.3||Electronic system for submission and review of clinical trials (for ZAHRI): report on number of proposals submitted and review process||ZAHRI|
|2.4||Electronic system for submission and review of clinical trials (for ZFDA)||ZFDA|
|2.5||Electronic submission of clinical trial applications between NIMR and TMDA linked||NIMR|
|2.6||Electronic submission of clinical trial applications between ZFDA and ZAHRI linked||ZFDA|
|3||3.1||Short course training module||MUHAS|
|3.2||Domesticated AVAREF Guidelines for clinical trials oversight||TMDA|
|3.3||Short training course (ethics) available online||KCRI|
|3.4||ZFDA and ZAHRI staff visit TMDA- MUHAS RCORE for a training visit in clinical trials||ZFDA|
|3.5||Researchers and scientists trained on research proposal/clinical trial protocol development and how to comply with national and international standards: report including course content, number of people trained and evaluation of training||MUHAS|
|3.6, 3.7 and 3.12||Workshop 1 and 2: ethics and regulatory issues pertaining to clinical trials||MUHAS|
|3.8||E-learning ethics course made available to universities on their websites (provide links to websites)||KCRI|
|3.9||IRBs trained to deliver the short training course (ethics and bioethics)||NIMR|
|3.10||Assessors and GCP inspectors trained on international standards and AVAREF guidelines and building capacity on reviewing the protocol and clinical trial application and inspections||MUHAS|
|3.11||Sustainability plan (maintenance and updating of the ethics course)||KCRI|
|3.13||PhD student in Medicines Regulations completes degree||MUHAS|
|4||4.1||Regional and District Medical Officers sensitised on ethics and regulations of clinical trials control||NIMR|
|4.2||Researchers trained on advocacy on laws, regulations and ethical issues pertaining to clinical trials||TMDA|
|4.3||Established model of community PV engagement to work with TMDA, NIMR, KCRI||TMDA|
|4.4||Community sensitization on ADRs reporting (Dar es Salaam)||TMDA|
|4.5||Community sensitization on ADRs reporting (Dodoma)||TMDA|
|4.6||Community sensitization on ADRs reporting (Unguja, Zanzibar)||NIMR|
|5||5.1||Mentorship programme established to sustain the capacity building||NIMR|
|6||6.1||Annual meeting (hosted by NIMR)||NIMR|
|6.2||TMDA and ZFDA staff attendance at regional meeting on medicines regulations: the Biannual Scientific Conference on Medical Products Regulations in Africa (SCoMRA)||MUHAS|
|6.3||Training visit to European centres of excellence||UStAN|
|6.4||Annual forum on ethics and regulation of medicines and medical products||NIMR|
|7||7.1||Kick off meeting||TMDA|
|7.2||Two staff members recruited (1 will be positioned at TMDA and another at ZAHRI)||TMDA|
|7.3||Project website/web page||TMDA|
|7.4||Social media (Twitter, Instagram)||TMDA|
|7.6||Profile on Research Ethics Web||NIMR|
|7.7||Stakeholder dissemination forum 1||TMDA|
|7.8||Presentations (Annual forum on ethics, on regulations, regional annual Conferences)||TMDA|
|7.9||Report on the evaluation of the project||TMDA|
|7.10||Participation in the EDCTP Forum 2021||TMDA|
|7.11||Communication campaign (radio, TV, press)||TMDA|
|7.12||Stakeholder dissemination forum 2||NIMR|
|7.13||Publication on “Improvement of clinical trial application approval and conduction in Tanzania” (open access)||NIMR|
|7.14||Publication on “Lessons learnt from ASCEND project” (open access)||TMDA|