Clinical Trial Directorate
‘Promoting Evidence Based Medicine’
Clinical Trials Directorate (CTD)arch
- About CTD
- Infrastructure & Facilities
- Initiatives Hosted at CTD
- Current &Completed Trials
- Publication
- Partnership &Collaboration
- Investigators &Study Team
- CTD Ambitions
- Graduate Students
- Contact
About CTD
The Clinical Trial Directorate (CTD) at the Armauer Hansen Research Institute (AHRI) is a national platform for the design, coordination, conduct, analysis, and reporting of high-quality clinical trials and bioequivalence studies. Established in the early 2000s, CTD has played a pioneering role in advancing ethical, scientifically rigorous, and internationally compliant clinical research in Ethiopia and the region.
Since initiating its first GCP-compliant study in 2001, CTD has supported evidence-based medicine, strengthened research capacity, and supported postgraduate education in clinical research. A broader scope of engagement was further marked by addition of bioequivalence studies during 2010’s. The directorate is thriving developing capacity including workforce development, infrastructure, quality standards, systems and networks. It is building a state-of-the-art clinical trial site infrastructure with all the facilities for phase I and bioequivalence studies. The CTD’s mandate is emanated from the Council of Ministers Regulation No. 376/2016 and 530/2023 where AHRI is to conduct, coordinate and build national capacity for clinical trials and bioequivalence studies.
CTD Vision:
To be a national and regional center of excellence for ethical and high quality clinical trials and bioequivalence studies.
CTD Mission:
- Conduct and lead ethical, scientifically sound clinical trials of drugs, vaccines, medical devices, diagnostics, and bioequivalence studies.
- Build sustainable national capacity through training, mentoring, and quality systems.
- Support national health priorities, innovation ecosystems, and regulatory sciences in Ethiopia and the region.
What We Do?
CTD supports the full spectrum of clinical development of drugs, vaccines, medical devices and diagnostics as well as Bioequivalence studies, including:
- Phase I–IV Clinical Trials (study design, conduct, coordination, and leadership)
- Bioequivalence & Clinical Pharmacology Studies
- Pharmacovigilance & Safety Monitoring
- Clinical validation of Medical Device and Diagnostic Trials
- Clinical trial sites assessment and setup
- Mentorship and support for emerging trial sites across Ethiopia.
- Clinical development and safety assessment of Traditional & Herbal medical Products
- Capacity Building & Training Programs
How we are organized?
CTD operates through four specialized divisions:
- Drugs and Therapeutics Trials Division; Led by Dr Adamu Bayissa, adamu.bayissa@ahri.gov.et
- Vaccines, Diagnostics & Medical Devices Trials Division; Led by Dr Kassa Haile, kassa.haile@ahri.gov.et
- Bioequivalence & Clinical Pharmacology Studies Division; Led by Mrs Netsanet Aragaw, netsanet.aragaw@ahri.gov.et
- Trials Management & Quality Assurance Division; Led by Mrs Muluye Shimelis, netsanet.aragaw@ahri.gov.et
Infrastructure and facilities
- A trial coordination center: a Phase I trial facility with 12- bed study admission ward and offices

- Bioequivalence center:
A 40+ beds Clinical Facilities with comprehensive participant and staff amenities

Medical Laboratory with a wide range of clinical diagnostic testing services

Bioanalytical Laboratory with state-of-the-art bioanalytical and pharmaceutical instruments

A. AHRI-IVI Collaborating Center
Mission:
Partnering for vaccine R&D and capacity building to improve global public health
B. Clinical Trials Network in Ethiopia (CTN-ET)
Mission:
Coordinating, promoting, and advocating for ethical, efficient, and inclusive clinical trials in Ethiopia through collaboration, capacity building, and policy engagement.
C. RER-CTO:
A regional initiative supporting ethics and regulatory excellence and harmonization in clinical trials oversight in sub-Saharan Africa.
Selected Current and Completed (Trials)
- Phase II Marburg virus vaccine trial (2025–2026)
- Bubble CPAP trials for severe childhood pneumonia, phase III to scale-up (2021–2028)
- Probiotic supplementation trials in preterm and small for gestational age infants (2025–2027)
- Telacebec for the treatment of Leprosy ‘TEBULA’: a multi-arm phase II clinical trial, 2025-27
- Serological testing and treatment for plasmodium vivax malaria: a cluster-randomised trial in Ethiopia ‘Pv-Statem’: Real world evidence, 2025-26
- Assessing new paediatric tablets of primaquine as radical cure in Ethiopia ‘APPE’: open label single arm randomized trial: Efficacy in real world evidence, 2024-25
- Clinical investigation to the safety and efficacy of two herbal ointment formulations for the treatment of Tinea corporis/cruris ‘ClinHerb1’: a phase I safety assessment, 2025
- Tafenoquine for vivax malaria radical cure: Feasibility and real-world evidence, 2024-25
- Impact of a cryptosporidiosis point of care test and treat strategy in children with diarrhea: A multicenter stepped-wedge cluster randomized trial ‘Crypto-T&T’: Real world Evidence, 2025-28
- Clinical Validation of AI for diagnosis of skin NTDs ‘SkincAir’, 2025-27
- LeishAccess: Prematurely terminated on futility analysis, 2023-24
- Safety of ointments formulations from essential oils of three medicinal herbs on the healthy human skin: Phase I randomized controlled trial ‘SafeHerb’: 2023-24
- The evaluation of a standard treatment regimen of anti-tuberculosis drugs for patients with MDR-TB (STREAM Stage 1 & 2): 9- and 6-months shorter regimens, 2012-2023 Registration number-ISRCTN78372190
- Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial, 2021-23 Registration Number- NCT03870243
- Active case detection and treatment of malaria in pregnancy using LAMP technology: A pragmatic randomized Multi-Center diagnostic outcomes trial ‘LAMPREG TRIAL’, 2021-23 Registration Number- NCT03754322
- An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care ‘SOLIDARITY Trial’: Remdesivir against SOC, 2020-2021
- An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care ‘SOLIDARITY Plus Trial’: Artesunate, Infliximab & Imatinib against SOC, 2022-23
- A phase I assessment of locally assembled mechanical ventillator‘RedVent2021’, 2022-23
- Single dose oral bioequivalence study of Primaquine 15 mg tablet (test product) and Primaquine 15 mg tablet (reference product) in healthy adult human subjects under fasting conditions, 2024-25
Selected & Featured Publications
- Mekonnen Teferi, Banchamlak Tegegne, Claire Kamaliddin, et al. Active case detection using loop-mediated isothermal amplification technology and treatment versus standard of care for malaria in pregnancy in Ethiopia (LAMPREG): a pragmatic randomised diagnostic outcomes trial. The Lancet Primary Care Volume 1, Issue 2100008August 2025.
- Gebre M, Haile K, Duke T, et al. Effectiveness of bubble continuous positive airway pressure for treatment of children aged 1-59 months with severe pneumonia and hypoxaemia in Ethiopia: a pragmatic cluster-randomised controlled trial. Lancet Glob Health. 2024 May;12(5):e804-e814. doi: 10.1016/S2214-109X(24)00032-9. Epub 2024 Mar 21. PMID: 38522443; PMCID: PMC11157334.
- Goodall RL, Nunn AJ, Meredith SK, Bayissa A, Bhatnagar AK, et al. Long-term efficacy and safety of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): extended follow-up of an open-label, multicentre, randomised, non-inferiority trial. Lancet Respir Med. 2024 Dec;12(12):975-987. doi: 10.1016/S2213-2600(24)00186-3. Epub 2024 Oct 1. PMID: 39366400.
- WHO Solidarity Trial Consortium. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses. Lancet. 2022 May 21;399(10339):1941-1953. doi: 10.1016/S0140-6736(22)00519-0. Epub 2022 May Erratum in: Lancet. 2022 Oct 29;400(10362):1512. doi: 10.1016/S0140-6736(22)01993-6. Erratum in: Lancet. 2024 Jan 13;403(10422):146. doi: 10.1016/S0140-6736(24)00005-9. PMID: 35512728; PMCID: PMC9060606.
- Goodall RL, Meredith SK, Nunn AJ, Bayissa A, et al. Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial. 2022 Nov 26;400(10366):1858-1868. doi: 10.1016/S0140-6736(22)02078-5. Epub 2022 Nov 8.PMID: 36368336
- Chiang CY, Bern H, Goodall R, et al. Radiographic characteristics of rifampicin-resistant tuberculosis in the STREAM stage 1 trial and their influence on time to culture conversion in the short regimen. BMC Infect Dis. 2024 Jan 30;24(1):144. doi: 10.1186/s12879-024-09039-z.
- Edosa M, Jeon Y, Gedefaw A, et al. Comprehensive Review on the Use of Oral Cholera Vaccine (OCV) in Ethiopia: 2019 to 2023. Clin Infect Dis. 2024 Jul 12;79(Suppl 1):S20-S32. doi: 10.1093/cid/ciae194. PMID: 38996040; PMCID: PMC11244176.
- Achalu DL, Kiltu AB, Teferi M, Mohammed FG, Workneh BD, Beyene KA, Gebretekle GB, Ali EE. Treatment outcomes of standardized injectable shorter regimen for multi-drugs resistant tuberculosis in Ethiopia: a retrospective cohort study. BMC Infect Dis. 2024 Aug 17;24(1):837. doi: 10.1186/s12879-024-09745-8. PMID: 39152383; PMCID: PMC11329998.
- Seralegne YZ, Wangamati CK, Bernabe RDLC, Farsides B, Aseffa A, Zewdie M. Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study. Dev World Bioeth. 2023 Mar;23(1):50-58. doi: 10.1111/dewb.12348. Epub 2022 Mar 5. PMID: 35247023; PMCID: PMC10367191.
- Rosu L, Madan JJ, Tomeny EM, Muniyandi M, et al. STREAM Study Health Economic Evaluation Collaborators. Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial. Lancet Glob Health. 2023 Feb;11(2):e265-e277. doi: 10.1016/S2214-109X(22)00498-3. Epub 2022 Dec 21.PMID: 36565704
- Tiemersma EW, Ali I, Alemu A, Avong YK, Duga A, Elagbaje C, Isah A, Kay A, Mmbaga BT, Mmari E, Mwamwitwa K, Nhlabatsi S, Sintayehu K, Arefayne A, Teferi M, Cobelens F, Härmark L.Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis.BMC Health Serv Res. 2021 Oct 8;21(1):1062. doi: 10.1186/s12913-021-07043-6.PMID: 34625085
- Nunn AJ, Phillips PPJ, Meredith SK, et al. A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis. N Engl J Med. 2019 Mar 28;380(13):1201-1213. doi: 10.1056/NEJMoa1811867. Epub 2019 Mar 13.PMCID: 30865791
- Abraham Aseffa, Joseph N. Chukwu, et al. Efficacy and Safety of ‘Fixed Dose’ versus ‘Loose’ Drug Regimens for Treatment of Pulmonary Tuberculosis in Two High TB-Burden African Countries: A Randomized Controlled Trial. PLoS One. 2016; 11(6): e0157434. Published online 2016 Jun 20. doi: 10.1371/journal.pone.0157434 PMCID: PMC4913909
- Jemal Hussein, Martha Zewdie, Lawrence Yamuah, Ahmed Bedru, et al. A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area. Trials. 2018; 19: 24. Published online 2018 Jan 10. doi: 10.1186/s13063-017-2354-0PMCID: PMC5764015
- Sachin N. Desai, Zenebe Akalu, Samuel Teshome, Mekonnen Teferi, et al. ns. Am J Trop Med Hyg. 2015 Sep 2; 93(3): 527–533. doi: 10.4269/ajtmh.14-0683; PMCID: PMC4559691
- Desai SN, Akalu Z, Teferi M, et al. Comparison of immune responses to a killed bivalent whole cell oral cholera vaccine between endemic and less endemic settings. Trop Med Int Health. 2016 Feb;21(2):194-201. doi: 10.1111/tmi.12641. Epub 2015 Dec 18.PMID: 26681205
- Aseffa A, Bedru A, Yamuah L, et al. Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia. 2007 Sep 3;25 Suppl 1:A79-82. doi: 10.1016/j.vaccine.2007.04.046. Epub 2007 May 4. PMID: 17548138
Partnership and Collaboration
The Armauer Hansen Research Institute (AHRI) works with national, international and local partners and collaborators to advance high-quality biomedical and public health research. These relationships range from long-term strategic partnerships to project-specific scientific collaborations.
In- country Partners/Collaborators
International Partner/collaborators
Global Research Networks & Consortia
- EDCTP-supported research consortia
- WHO-coordinated research networks
- One Health and genomics research initiatives
Investigators and Study team
CTD Ambitions & Collaboration Opportunities
- A National and Regional Center of Excellence in Clinical Trials and Bioequivalence Studies for standard practices and training
- Realize a semi-autonomous, regulatory-compliant, internationally recognized bioequivalence center offering full services for regulatory submissions and pharmaceutical R&D.
- Strong Research teams that can lead and support local innovation for clinical development of drugs, vaccines, biologicals, diagnostics and medical devices.
- Leverage clinical pharmacology expertise to support IND regulatory submissions for new molecules.
- Establish AHRI-affiliated trial sites nationwide across diverse medical specialties and patient cohorts.
- Broaden access to trials and bioequivalence studies through extensive local and international networks and partnerships.
- Contribute to CTN-ET’s growth as a key entity shaping Ethiopia’s clinical trials and bioequivalence ecosystem.
- Invest in tailored training programs and leadership that are recognized regionally, continentally, and internationally.
Participate in global initiatives for pandemic preparedness, strengthening local capacity in vaccine trials and beyond.
Graduate students
Contact

Dr.Mekonnen Teferi
Director,Clinical Trial Directorate
Email: mekonnen.teferi@ahri.gov.et
Tel: +251911103233








































































