Korle-Bu Teaching Hospital

Guggisberg Ave, Accra, Ghana

Public hospital

Serves Western Africa

The Korle-Bu Teaching Hospital (KBTH) is a public hospital in Accra, Ghana. KBTH is the leading national referral center in Ghana and serves more than 500,000 patients per year from across the country and from nearby countries in West Africa. The hospital has 2,000 beds and a clinical staff of 1,000. KBTH has previously hosted clinical trials for both infectious and non-communicable diseases, including a Phase I trial for retinal disease and Phase III trials for breast cancer and pediatric malaria. AC3T’s cancer clinical trials capacity data show that KBTH performs well across all dimensions; though the hospital currently lacks certain diagnostic capabilities. KBTH hosts the national Radiotherapy Center of Excellence, offering a range of radiotherapy treatment options for cancer patients.

Links to previous clinical trials:

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1940

https://clinicaltrials.gov/ct2/show/NCT01452672

https://clinicaltrials.gov/ct2/show/NCT00406146

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): 4-8 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 6 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 activities3
    Prepares and administers study drug10
    Collects and processes study data and maintain data integrity4
    Monitors site processes and ensures quality2
    Biostatisticians1
    Database programmers1
    Epidemiologists1
    Pathologists11
    Pharmacists10
  • 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:

  • None

    • 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 Korle-Bu Teaching Hospital

    George Obeng Adjei, M.D., Ph.D.

    Director, Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana; Professor of Pediatric Clinical Pharmacology, University of Ghana; Chairperson, Scientific and Technical Committee, Institutional Research Board, Korle-Bu Teaching Hospital

  • Infectious Diseases

    • Overview

    Prof. Adjei is the Director of the Centre for Tropical Clinical Pharmacology and Therapeutics, and Professor of Pediatric Clinical Pharmacology at the University of Ghana. He is also the Chairperson of the Scientific and Technical Committee of the Institutional Research Board (IRB) at Korle-Bu Teaching Hospital. He specializes in pediatric clinical pharmacology, especially malaria. He has published extensively on pharmacokinetics and drug modeling of antimalarial medications, as well as immunology and genetic factors associated with malaria and sickle cell disease. He is interested in clinical research ethics and serves on multiple IRBs. Prof. Adjei’s clinical trial interests and experience include diagnostic, drug (small molecule), epidemiological, observational, and precision medicine studies of pediatric infectious diseases in developing country settings.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal HSP Training

    • Trial Phases

  • Phase I
  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2478668/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176868/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3536610/

    https://pubmed.ncbi.nlm.nih.gov/28761582/

    https://pubmed.ncbi.nlm.nih.gov/36829179/

    https://pubmed.ncbi.nlm.nih.gov/38778572/

    *Definitions

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