Center for Innovative Drug Development and Therapeutic Trials for Africa

2Q92+V77, Addis Ababa, Ethiopia

University or Academic Center

Serves Eastern Africa

The Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa) is a university research institution in Addis Ababa, Ethiopia. CDT-Africa is part of the Addis Ababa University College of Health Sciences and Tikur Anbessa Hospital, a public hospital with 700 beds and a clinical staff of nearly 600, that treats patients from Ethiopia and surrounding countries in the Eastern and Southern Africa regions. CDT-Africa has previously hosted clinical trials, including trials of infectious diseases such as tuberculosis and leishmaniasis and non-communicable diseases such as schizophrenia. Clinical trials capacity data show that CDT-Africa performs well across all dimensions. CDT-Africa has access to thousands of patients treated each year and all the equipment and resources housed at Tikur Anbessa Hospital and other hospitals within Addis Ababa and outside. It works across the large regions of the country, including the Amhara, Oromia and the Southern Regions. It has a large field study site in south Ethiopia with access to over a million residents.

Links to previous clinical trials:

https://cdt-africa.org/index.php/projects/exit-tb

https://clinicaltrials.gov/ct2/show/NCT01809158

https://clinicaltrials.gov/ct2/show/NCT01724476

Site Capabilities

Clinical Trial Experience

Therapeutic area interests:

Cancer

Infectious disease

Institution has received grant(s) from:

National Funder(s)

International Funder(s)

Sponsors for previous clinical trials include:

Academic

Government

Industry

Investigator-initiated

Previous clinical trials conducted:

Behavioral

Diagnostic

Drug – biologic

Drug – small molecule

Epidemiological

Observational

Surgical

Vaccine

Study phase capabilities:

Phase I

Phase II

Phase III

Phase IV

Pediatric research capabilities:

Yes

Institution Regulatory/Research Ethics Committees

Frequency of meetings: Monthly

Application turnaround time (IRB/IEC): 3-4 weeks

Average time from receipt of final protocol to review and approval of study by all relevant committees: 24 weeks

Additional compliance:

IRB/IEC in compliance with IC E6(R2) in terms of composition, functions, and operations guidelines

Institution and/or local regulation mandates the distribution of study safety reports to IRB/IEC

Institution Staffing Resources

Staff type	Staff available (y/n) and specialty experience
Research coordinator	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Research nurse	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Research data manager	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Quality assurance manager	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Biostatisticians	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Database programmers	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Epidemiologists	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Pathologists	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)
Pharmacists	Yes -Experience in Clinical Trials -Training in Human Subjects Protection (HSP) -Training in Good Clinical Practice (GCP)

Institution Diagnostic Capabilities

Institution has personnel capable of performing diagnostic biopsies

Biopsies performed on-site:

Core needle biopsy

Endoscopic biopsy

Fine needle aspirate

Liquid biopsy

Sentinel lymph node biopsy

Skin biopsy

Surgical biopsy

Laboratory basics:

Institution has a laboratory on site

Institution sends diagnostic samples to external laboratory

Institution’s laboratory has been inspected or audited

Laboratory accreditations:

WHO AFRO Accreditation

Tests performed on-site:

Complete blood count (CBC) with differential

Comprehensive metabolic-chemistry panel (CMP)

Routine urinalysis

Antibody tests

Antigen tests

Antimicrobial susceptibility and sensitivity

Bacterial smear and culture

Flow cytometry

Fluorescent in situ hybridization (FISH)

Fungal culture

Genetic testing

Histology

Immunohistochemistry (IHC)

Laboratory-developed tests (LDTs)

Microscopy

Ova and parasite (O&P) test

PCR and/or RT-PCR

Other nucleic acid amplification tests (NAATs)

Viral culture

Viral load

Imaging capabilities:

Computed tomography (CT)

Magnetic resonance imaging (MRI)

Positron emission tomography (PET)

Nuclear imaging

Ultrasound

X-ray

Pediatric imaging

Institution Research Systems, Recordkeeping, and Data Management

Institution adheres to informed consent processes compliant with ICH E6(R2)

Institution follows ICH E6(R2) for collection and storage of source documentation for paper and/or electronic records

Institution stores patient records/source documents (paper/electronic) in a secured, limited access location during and after the trial

For source documents collected via electronic data capture, institution has a validated system and site procedures that follow ICH E6(R2) 5.5 guidelines

Institution has process in place for proper storage, archiving, and retrieval of essential study document per ICH 8.1

Institution study monitors have full access to source documents or certified copies of source documents (if electronic) if direct access can’t be obtained

Institution has a finance administration team

Institution undergoes routine financial audits

Institution Pharmacy

Pharmacy on site

Pharmacy has secure, limited access storage area with daily temperature monitoring and backup generator

Pharmacy has standard processes in place to ensure proper receipt, handling, and storage of investigational study drug/vaccine and comparators

Pharmacy has standard processes in place to ensure proper dispensing

Pharmacy has standard processes in place to ensure proper labeling that maintains the study blind

Pharmacy has standard processes in place to ensure proper drug/vaccine accountability, retrieval, and return or destruction of unused product

Institution has a secure, limited-access investigational drug/vaccine storage area with daily temperature monitoring

Institution’s pharmacy has a backup generator sufficient to run necessary equipment, refrigerators, freezers, etc.

Institution Equipment

Protocol for managing anaphylactic shock

Institution has a blood bank

Institution carries out blood transfusions for patients that need it

Functioning IV infusion pumps

Functioning basic life support equipment (crash cart)

Functioning electrocardiogram (EKG)

Availability of banked blood at institution:

Always available

Occasionally available

Rarely available

Institution performs the following routine blood screening tests on banked blood:

HIV

HBV

HCV

HPV

HTLVI

HTLVII

Syphilis

Additional information:

Institution’s equipment is calibrated and maintained per manufacturer’s guidelines

Institution’s equipment calibration and maintenance is documented

Institution’s laboratory has a secure, limited access biological specimen storage area with daily temperature monitoring

Institution’s laboratory has a backup power source, with alarm, sufficient to run necessary equipment, refrigerators, freezers, etc.

Institution maintains and uses a diagnostic imaging protocol manual

Laboratory maintains and uses a laboratory protocol manual

Program-Specific Capabilities

Institution Cancer Treatment Capabilities and Equipment

Treats cancer patients

Performs surgical excisions

Administers chemotherapy

Uses radiation therapy

Radiotherapy machines on site:

Linear accelerator

Cobalt 60

Brachytherapy machine

Institution Infectious Disease Treatment Capabilities and Equipment

Treats infectious disease patients

Protocol for managing sepsis

Vaccines administered on site:

COVID-19

Diphtheria

Hepatitis

Haemophilus influenzae type b (Hib)

Human papillomavirus (HPV)

Influenza

Measles

Meningococcal meningitis

Mumps

Pertussis

Pneumococcal disease

Poliomyelitis

Rabies

Rotavirus

Rubella

Tetanus

Tuberculosis

Yellow Fever

Infectious disease treatment services performed on site:

Antimicrobial/antibiotic drugs (small molecules or biologics; including antibacterial, antifungal, antiparasitic, antiviral medicines)

Immunotherapies

Supportive care/symptom management

Surgery

Viral load monitoring

Investigators at Center for Innovative Drug Development and Therapeutic Trials for Africa

Eyasu Makonnen Eshetu, Ph.D.

Deputy Head and Clinical Trials Lead, Center for Innovative Drug Development and Therapeutic Trials for Africa; Professor of Pharmacology, Addis Ababa University

Cancer

Infectious Diseases

Overview

Prof. Makonnen is the Deputy Head and Clinical Trials Lead of the Center for Innovative Drug Development and Therapeutic Trials for Africa, and Professor of Pharmacology at Addis Ababa University. His clinical trial interests and experience include drug (biologic, small molecule, phytotherapy, pharmacokinetics, pharmacodynamics, pharmacogenetics) and observational studies for infectious diseases (HIV, leishmaniasis, schistosomiasis, soil-transmitted helminthiases, and tuberculosis) and cancer (breast and cervical).

Formal Clinical Trial Training*

Formal GCP Training

Formal GCLP Training

Formal HSP Training

Trial Phases

Phase I

Phase III

Phase II

Phase IV

Experience Conducting or Participating in Clinical Trials: Yes

Previous Clinical Trials

https://dndi.org/research-development/portfolio/ssg-pm/

https://idpjournal.biomedcentral.com/articles/10.1186/s40249-024-01176-6

https://www.mdpi.com/2077-0383/11/21/6300

https://clinicaltrials.gov/study/NCT05947513

Abebaw Fekadu Wassie, M.D., Ph.D.

Head, Center for Innovative Drug Development and Therapeutic Trials for Africa; Professor of Psychiatry, Addis Ababa University

Infectious Diseases

Overview

Prof. Fekadu is the Head of the Center for Innovative Drug Development and Therapeutic Trials for Africa, and Professor of Psychiatry at Addis Ababa University. He has expertise in clinical psychopharmacology; complex mood disorders; research coordination; design and implementation of drug, device, and complex intervention trials; development of measurement tools; and knowledge translation. His clinical trial interests and experience include behavioral, diagnostic, drug (small molecule), epidemiological, and observational studies of infectious diseases (particularly tuberculosis and toxoplasmosis); mental health; and the intersection of infectious diseases and mental disorders.

Formal Clinical Trial Training*

Formal GCP Training

Formal HSP Training

Trial Phases

Phase II

Phase IV

Phase III

Experience Conducting or Participating in Clinical Trials: Yes

Previous Clinical Trials

https://pubmed.ncbi.nlm.nih.gov/35303462/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9514884/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4222697/