Evidence map›Paper›PMID 42036537›Full record

ArticleTherapeutic innovation & regulatory science2026

Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania.

Kissa W Mwamwitwa, Castory G Munishi, Paul Malaba Makoye, Aisha M Maganga, Sunzy M Chambiri, Goodluck G Nyondo, Eulambius M Mlugu, Yonah H Mwalwisi, Ndekya Oriyo, Mayassa S Ally and 7 more

Abstract read
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Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Kissa W MwamwitwaTanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.
Castory G MunishiPharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.
Paul Malaba MakoyePharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.
Aisha M MagangaTanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.
Sunzy M ChambiriTanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.
Goodluck G NyondoPharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.
Eulambius M MluguPharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.
Yonah H MwalwisiTanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.
Ndekya OriyoNational Institute for Medical Research (NIMR), P. O. Box 9653, Dar es Salaam, Tanzania.
Mayassa S AllyZanzibar Health Research Institute, P. O. Box 236, Zanzibar, Tanzania.
Burhani O SimaiZanzibar Food and Drugs Agency, P. O. Box 3595, Zanzibar, Tanzania.
Wilber SabiitiDivision of Infection and Global Health, School of Medicine, University of St. Andrews, St. Andrews, UK.
Blandina T MmbagaKilimanjaro Clinical Research Institute (KCRI), P. O. Box 2236, Moshi, Kilimanjaro, Tanzania.
Doreen MlokaPharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.
Nyanda E NtinginyaNational Institute for Medical Research - Mbeya Medical Research Centre, Mbeya, Tanzania.
Adam M FimboTanzania Medicines and Medical Devices Authority (TMDA), P. O. Box 77150, Dar es Salaam, Tanzania.
Eliangiringa A KaalePharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), P. O. Box 65013, Dar es Salaam, Tanzania.

Funding

European and Developing Countries Clinical Trials Partnership ASCEND Project CSA2019ERC-2683
6 · The paper itself

Abstract

backgroundSub-Saharan Africa carries 25.0% of the global disease burden but hosts only 2.0% of clinical trials worldwide. A key measure to address this challenge is shortening review timelines and enhancing the capacity of protocol reviewers in regulatory authorities. This study, triggered by the Tanzania medicines and medical devices authority and stakeholders, aimed to assess the competency of assessors in reviewing clinical trial applications and to conduct an intervention involving didactic and hands-on training.

methodsA descriptive cross-sectional study was conducted from February 2021 to June 2021 using an online survey targeting 128 participants from medicines regulatory authorities, regional ethical committees, institutional review boards, and research institutions. A 70-hour (7 credit) course was developed and implemented in 30 clinical trial assessors.

resultsThe survey had a 70.3% response rate, with 58.9% male participants. Over half of the participants held a master's degree. The study revealed that 94.0% needed training in clinical assessment, 92.2% in quality assessment, and 92.6% in statistical assessment for clinical trial protocols. Following pre- and post-training evaluation, one sample t-test indicated a statistically significant difference in the mean scores, 18.96, CI (13.15-24.76), indicating an improvement in the knowledge of the participants.

conclusionThe study identified significant gaps in the competency of clinical trial applications assessors and ethical reviewers in Tanzania according to the African vaccine regulatory forum guidelines for review of clinical trial protocols. The targeted training improved the capacity of 30 assessors, yet further targeted and stratified capacity-building trainings are recommended to enhance regulatory capacity.

Indexed as

Capacity BuildingClinical Trials as TopicEthical ReviewNeeds AssessmentCross-Sectional StudiesFemaleHumansMaleSurveys and QuestionnairesTanzaniaAVAREF guidelinesClinical trial assessorsEthical reviewersTraining needs

Identifiers

PMID42036537

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.