Home » Clinical Trial

Clinical Trial Directorate

                 ‘Promoting Evidence Based Medicine’

 Clinical Trials Directorate (CTD)arch

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:

Infrastructure and facilities

  • A trial coordination center:  a Phase I trial facility with 12- bed study admission ward and offices

trial off

  • Bioequivalence center:

A 40+ beds Clinical Facilities with comprehensive participant and staff amenities

be

Medical Laboratory with a wide range of clinical diagnostic testing services

mdc

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

bioanalytics

A. AHRI-IVI Collaborating Center

Mission:

Partnering for vaccine R&D and capacity building to improve global public health

cnetB. 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.

rer

 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

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

moh   ephi    amharah  judbuhauaruuogstpblh           stpeter        gandi       yekatit12

International Partner/collaborators

iviwholshcarolina
imcnora2   sanssidauocsabinchildhjhuubpastor 2ipuomcismuooxicddrdndipathepicmekereufindcarlosuoed mrvitaltayptundlhicalgaitmuotwuoaflstm

Global Research Networks & Consortia

  • EDCTP-supported research consortia

edctp3

  • WHO-coordinated research networks
  • One Health and genomics research initiatives

Investigators and Study team

Picture

Full Name

Research Interest

Position/Rank

Telephone

E-mail address

Adamu B

Adamu Bayissa Kiltu

Drugs and vaccine Clinical Trials

Senior Researcher /MD, MPH/

+251929041898

adamubayissa@ahri.gov.et

Kassa H

Kassa Haile

Clinical trial, drug/device trial

Senior Researcher /M.D, MPH/

+251911396555

Kassa.haile@ahri.gov.et

Hawult Taye

Hawult Taye Adane

Epidemiology, Trials Methods,

Senior Researcher /MPH, PHD/

+251911535973

hawultachew@gmail.com

tigist

Tigist Adnew Getaneh

Oxygen therapy, pediatrics health, vaccine research

Researcher, /MD, pediatrician/

+251922736330

tigist.adnew@ahri.gov.et

silesh

Sileshi Belew Yohannis

Bioanalytical (BE/BA), Clinical Pharmacology, Pharmaceutical analysis

Senior Researcher, PhD

+251904067994

sbphar2009@gmail.com

Mekonnen

Mekonnen Teferi Mekonnen

Products development, Bioequivalence & Clinical pharmacology, Pharmacovigillance

Researcher /DVM, MPharm/

+251911103233

mekonnen.teferi@ahri.gov.et

tadye

Tadeye Abeje

Clinical Research

Researcher /MD, MPH/

+251912055473

tadeyeal@gmail.com

Daniel L

Daniel Legese Achalu

Pharmacoepidemiological Researches

Researcher, Pharmacy Coordinator /B.pharm, MBA, MSc/

+251912750932

danigateline@gmail.com

muluye

Muluye Shimeles Getahun

CRA and project management

Quality manager, Clinical monitor /BSc, MSc/

+251 911368499

muluye.shemeles@ahri.gov.et

Netsanet A

Netsanet Aragaw Tegegne

Clinical trial in infectious disease

Study Coordinator /BSc Nurse, MPH/

+251911357189

netsuhe2014@gmail.com

edlawit

Edilawit Mesfin Getachew

Infectious diseases epidemiology, Field Vaccine effectiveness Research

Associate Researcher /MD/

+251912287825

edmesfin2017@gmail.com

beti

Bethlehem Solomon

Clinical and implementation research on infectious diseases

Medical Researcher /MD, MSc/

+251925868781

betysolmn@gmail.com

Hiwot A

Hiwot Asmerom

Clinical Trial Infectious Disease

Study Coordinator, /BSc Nurse, MPH/

+251911483571

asmeromhiwot5@gmail.com

Melat G 221x300

Melat Gebremedihen

Teklemariam

Research ethics on drug and vaccine trials, implementation study

Study Coordinator /BSc, MPH)

+251936960547

melatgebremedhin5@gmail.com

anat

Anatia Kifle

Drug and vaccine clinical trials, Non- communicable disease

Associate Researcher /MD, MSc./

+251912494318

kifleanatia@gmail.com

tahtawi

Tahitawit Mulatu

Drug and vaccine clinical trials, Infectious disease

Associate Researcher /MD, MSc./

+251983312115

Tahitawitmula2@gmail.com

fre

Firehiwot Birhanu Gebremedhin

Non-infectious diseases

Researcher associate /MD, MPH/

0913561509

frehiwotbirhanu92@gmail.com

tsuruy

Tsuruy Hagos Mesfin

Vaccine Trials, Infectious diseases & AMR studies, Non-communicable diseases

Project coordinator /MD, MPH/

+251 966250599

tsuruy.mesfin@gmail.com

 

 Amanuel Lulu

Public Health, implementation Research

 Associate researcher /MD/

+251924847334

amanuel.lulu1@gmail.com

aliyi

Aliyi Amano Genemo

Clinical Trial Operations, Ethical & Regulatory Frameworks

Associate Researcher /BPharm, MSc/

+251947407134

aliyiamanog@gmail.com

Ermias H

Ermias Hundito Abebe

Drug development in infectious and non-infectious diseases

Research Assistant /BSc/

+251916303538

ermiashundito@yahoo.com

yemisrach

Yemisrach Zewdie Seralegne

One health, ethics and bioethics

Associate Researcher II /B.A, M.A/

+251911154197

yemzewd@gmail.com

yajeb

Yajeb Melesse  Belay

Nutraceuticals

Associate Researcher /Bpharm, MSc/

+251911690947

yajebmelesse@yahoo.com

mickael

Mikael Abraham Hailemariam

QA and Monitoring of Clinical Research, Trial Management

Quality Officer /BSc, MPH/

+251964003558/+251912758022

miki4se@yahoo.com

tsega

Tseganesh Asefa Yifru

Public health, Oncology, Clinical trials, Nutrition

Associate researcher II

/ BSc, MSc/

+251922736330

tseganesh16@gmail.com

endalk

Endalkachew Birhanu

Lab technology, Biochemistry, Metabolic disorder

Associate researcher /BSc, MSc/

0913186148

endalkalem16@gmail.com

 

Muluken Akalu

Hematology, microbiology

Senior Lab Tech /BSc, MSc/

+251970220178

akalumulukan@gmail.com

kerat

Kerat Ali

Public health,clinical and any health qualitative research

Researcher Assistant /BSc/

+251983755324

kerat23ali@gmail.com

mulu

Muluemebet Hailu

Laboratory diagnostics, public health, and clinical trials

Researcher Assistant /BSc/

+251922859016

hailumulumebat@gmail.com

saron

Saron Naji Gebremariam

Bioequivalence study and Drug trial study

Pharmacist /BSc, MSc/

251920163383

saronnaji@gmail.com

kass

Kasahun Wale

Analytical research areas

Researcher II

+251915556289

kasahun322@gmail.com

asamene

Asamene Embiale Taye

Bioequivalence and environmental toxicity

Senior researcher, Associate professor/ PHD/

+251922875429

yembiale2@gmail.com

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

gemechu

Gemmechu Hasen

Bioequivalence studies, pharmacokinetic study,  antimicrobial resistance                                                          

Researcher II, PhD Fellow

+251916973323

gemmechuhasen2009@gmail.com

derso

Derso Furgassa

Clinical research

Assistant researcher II/BSc lab Tech/

+251941958591

dersoyek@gmail.com

Contact

Mekonnen

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