University of Nairobi, College of Health Sciences

Nairobi, Kenya

University or academic center

Serves Eastern Africa

The University of Nairobi, College of Health Sciences is an Academic center in Nairobi, Kenya. The University of Nairobi is affiliated with the Kenyatta National Hospital (KNH), the main teaching hospital for the College of Health Sciences. KNH is one of Kenya’s largest referral hospitals, treating 500,000-700,000 patients from across Kenya and neighboring countries in Eastern and Central Africa. KNH has 2000 beds and a clinical staff of 2,320, nearly 400 of which are employed by the College of Health Sciences. The University of Nairobi, College of Health Sciences has previously hosted clinical trials, including drug trials for breast cancer and contraceptive medicine and an HIV vaccine trial. AC3T’s cancer clinical trials capacity data show that the University of Nairobi, College of Health Sciences performs well across all dimensions, has a fully-equipped cancer treatment center and oncology clinics, but lacks certain diagnostic imaging capabilities.

Links to previous clinical trials:

https://clinicaltrials.gov/ct2/show/NCT00049439

https://clinicaltrials.gov/ct2/show/NCT03452111

https://clinicaltrials.gov/ct2/show/NCT03699241

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
  • Epidemiological
  • Diagnostic
  • Drug
  • 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): 6 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 8 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 typeNumber of staff
    Performs study site coordination and manage daily operational activities2
    Prepares and administers study drug8
    Collects and processes study data and maintain data integrity10
    Monitors site processes and ensures quality2
    Biostatisticians4
    Database programmers4
    Epidemiologists4
    Pathologists20
    Pharmacists19
  • At least one staff member has clinical trials experience
  • At least one staff member has HSP training
  • At least one staff member has GCP training
  • At least one staff member has GCLP training

    • Institution Diagnostic Capabilities

  • Institution has personnel capable of performing diagnostic biopsies

    • Biopsies performed on-site:

  • Pleural tap
  • Abdominal tap
  • Lumbar puncture (spinal tap)

    • 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:

  • Kenya National Accreditation Services (KENAS)
  • Qualogy

    • Tests performed on-site:

  • Complete blood count (CBC) with differential
  • Comprehensive metabolic-chemistry panel (CMP)
  • Routine urinalysis
  • Antibiotic sensitivity
  • Bacterial culture
  • Flow cytometry
  • Histology
  • Immunohistochemistry
  • Microscopy

    • 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
  • Site documents all procedures conducted and the results

    • 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

    • Institution Infectious Disease Treatment Capabilities and Equipment

    Data collection in progress

    Investigators at University of Nairobi, College of Health Sciences

    Jessie N. Githanga, MBChB, MMed

    Associate Professor, Department of Human Pathology, University of Nairobi; Consultant Hematologist, Kenyatta National Hospital

  • Cancer

    • Overview

    Prof. Githanga is an Associate Professor in the Department of Human Pathology at the University of Nairobi, and a Consultant Hematologist at Kenyatta National Hospital. She is also a member of the executive committee of the City Cancer (C/Can) Challenge for Nairobi City. After finishing her MBChB and MMed (pathology) degrees, she completed a post-graduate fellowship in cytogenetics and hematology. Her clinical interests include pathology, blood transfusions, and hematology (including oncology and genetic disorders [e.g., sickle cell disease]). Her clinical trial interests and experience include drug (monoclonal antibody and small molecule) studies for adult and pediatric cancers (including esophageal cancer, Kaposi’s sarcoma, lymphomas, and Wilms tumor) and sickle cell disease. She is currently the principal investigator for several multinational clinical trials.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal HSP Training
  • Formal GCLP Training

    • Trial Phases

  • Phase I
  • Phase III
  • Phase II
  • Phase IV

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3431556/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9523370/

    https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.25273

    https://www.nejm.org/doi/full/10.1056/NEJMoa1512021

    https://onlinelibrary.wiley.com/doi/10.1002/pbc.28977

    https://clinicaltrials.gov/study/NCT04474314

    https://www.nejm.org/doi/full/10.1056/NEJMoa1903212

    https://clinicaltrials.gov/study/NCT03573882

    https://doi.org/10.1182/blood-2023-188677

    https://clinicaltrials.gov/study/NCT05561140

    https://doi.org/10.1097%2F01.HS9.0000928300.84715.89

    https://clinicaltrials.gov/study/NCT05348915

    https://pubmed.ncbi.nlm.nih.gov/35019238

    https://clinicaltrials.gov/study/NCT05031780

    Walter Godfrey Jaoko, MBChB, Ph.D.

    Director, KAVI-Institute of Clinical Research, University of Nairobi; Professor, Department of Medical Microbiology & Immunology, University of Nairobi; Honorary Consultant, Kenyatta National Hospital

  • Infectious Diseases

    • Overview

    Prof. Jaoko is the Director of the KAVI-Institute of Clinical Research, a Professor in the Department of Medical Microbiology at the University of Nairobi, and an Honorary Consultant at Kenyatta National Hospital. In addition to his MBChB and Ph.D. (medical microbiology), he has master’s degrees in tropical medicine and global bioethics, and a diploma in research methodology. He has extensive expertise in infectious disease research, especially HIV and other sexually transmitted infections. His clinical trial interests and experience include behavioral, drug (small molecule), epidemiological, pediatric, and vaccine studies for COVID-19/SARS-CoV-2, Ebola virus disease, and HIV. Prof. Jaoko is currently embarking on a candidate tuberculosis vaccine clinical trial.

    Formal Clinical Trial Training*

  • Formal GCP 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC2943475/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355215/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4414927/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5006719/

    https://pubmed.ncbi.nlm.nih.gov/20877623/

    https://clinicaltrials.gov/study/NCT04553016

    https://www.sciencedirect.com/science/article/abs/pii/S0264410X0601214X

    https://pubmed.ncbi.nlm.nih.gov/20877623/

    https://clinicaltrials.gov/study/NCT02099994

    https://clinicaltrials.gov/study/NCT01371175

    https://clinicaltrials.gov/study/NCT01496989

    https://clinicaltrials.gov/study/NCT04904471

    https://pubmed.ncbi.nlm.nih.gov/37981473/

    Elizabeth Maleche Obimbo, MBChB, MMed

    Professor of Pediatrics, Pediatric Pulmonologist, and Epidemiologist, Department of Pediatrics and Child Health, University of Nairobi; Consultant Pediatric Pulmonologist, Kenyatta National Hospital

  • Infectious Diseases

    • Overview

    Prof. Obimbo is Professor of Pediatrics, Pediatric Pulmonologist, and Epidemiologist in the Department of Pediatrics and Child Health at the University of Nairobi, and a Consultant Pediatric Pulmonologist at Kenyatta National Hospital. She is also a Research Professor at the University of Washington; a member of the Core Team of the Child & Adolescent Tuberculosis working group of the Global Tuberculosis Program; Co-Chair of the Pediatric Antiretroviral Drugs Working Group of the World Health Organization (WHO); and a member of the Kenya Committee of Experts on Child and Adolescent Tuberculosis and Lung Diseases. In addition to her MBChB and MMed (pediatrics) degrees, she has a Master of Public Health (MPH) in epidemiology. Her clinical trial interests and experience include behavioral, drug (small molecule), epidemiological, observational, and vaccine studies of HIV, tuberculosis, and pediatric respiratory diseases. Her clinical research has included epidemiological analyses predicting disease progression and mortality in HIV; immune responses in HIV and tuberculosis infections; prophylaxis to prevent tuberculosis; financial incentives to increase HIV testing; pharmacokinetics of antiretrovirals in children; pediatric antiretroviral therapy trials; and developmental studies of children with HIV.

    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://www.ncbi.nlm.nih.gov/pmc/articles/PMC8282257/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791594/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4414927/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10756690/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777310/

    https://clinicaltrials.gov/study/NCT04041791

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4370168/

    *Definitions

    • HSP – Human Subjects Protection
    • GCP – Good Clinical Practice
    • GCLP – Good Clinical Laboratory Practice