Komfo Anokye Teaching Hospital

Okomfo Anokye Road, Kumasi, Ghana

Public Hospital, Government Research Institution

Serves Western Africa

The Komfo Anokye Teaching Hospital (KATH) is a public hospital in Kumasi, Ghana. KATH is the second largest hospital in Ghana and serves 350,000 patients per year from 13 of the 16 administrative regions of the country. The hospital has 1,200 beds. KATH has previously hosted clinical trials for both infectious and non-communicable diseases, including Phase III trials for
latent tuberculosis infection and for pediatric sick cell disease. Clinical trials capacity data show that KATH performs well across all dimensions. KATH has an IRB which is registered with the US Health and Human Services with a federal wide assurance (FWA) The hospital offers radiotherapy, surgery, and chemotherapy services for cancer patients.

Links to previous clinical trials:

https://clinicaltrials.gov/ct2/show/NCT00931736

https://clinicaltrials.gov/ct2/show/study/NCT03329599

https://clinicaltrials.gov/ct2/show/study/NCT03615924

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: 5-6 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 typeStaff available (y/n) and specialty experience
    Research coordinatorYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Research nurseYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    Research data managerYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    Quality assurance managerYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    BiostatisticiansYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    Database programmersYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    EpidemiologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    PathologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    PharmacistsYes
    -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:

  • College of American Pathologists (CAP)
  • International Organization for Standardization (ISO)
  • World Health Organization (WHO)
  • United Kingdom National External Quality Assessment Service (UKNEQAS)

    • 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
  • 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:

  • HPV
  • Yellow Fever
  • Hepatitis B
  • COVID-19

    • 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 Komfo Anokye Teaching Hospital

    Daniel Ansong, MBChB

    Professor of Pediatrics, Kwame Nkrumah University of Science and Technology; Consultant Pediatrician, Komfo Anokye Teaching Hospital; Lead Clinician, WHO/AFRO Invasive Bacterial Vaccine-Preventable Disease Surveillance Program, Department of Child Health, Komfo Anokye Teaching Hospital

  • Infectious Diseases

    • Overview

    Prof. Ansong is a Consultant Pediatrician at Komfo Anokye Teaching Hospital (KATH); Lead Clinician for the WHO/AFRO Invasive Bacterial Vaccine-Preventable Disease Surveillance Program in the Department of Child Health at KATH; and a Professor of Pediatrics at Kwame Nkrumah University of Science and Technology. In addition to his MBChB, he has a Master of Science in epidemiology and biostatistics. His clinical trial interests and experience include behavioral, drug (small molecule), and vaccine studies for a variety of infectious diseases, including malaria, Haemophilus influenzae, Streptococcus pneumoniae, rotavirus, rubella, typhoid, and non-typhoid salmonellosis. He is also interested in non-communicable diseases, including sickle cell disease, hypertension, and poisons. Prof. Ansong is currently the principal investigator for multiple clinical trials, including RTS,S malaria vaccine and Severe Malaria A Research and Trials Consortium – Multisite Adaptive Platform (SMAART-MAP) trials. He is also a co-investigator for several clinical trials, including behavioral interventions using mobile apps to improve care, and a study to improve sepsis outcomes.

    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/PMC9420828/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4762279/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4259007/

    Sandra Kwarteng Owusu, MBChB, MPhil

    Pediatric Pulmonologist, Komfo Anokye Teaching Hospital; Senior Lecturer, Department of Child Health and Pediatrics, School of Medicine and Dentistry, College of Health Science, Kwame Nkrumah University of Science and Technology

  • Infectious Diseases

    • Overview

    Dr. Sandra Kwarteng Owusu is a Pediatric Pulmonologist at Komfo Anokye Teaching Hospital and a Senior Lecturer in Child Health and Pediatrics at Kwame Nkrumah University of Science and Technology. Her research focuses on improving lung health outcomes in pediatric respiratory diseases. Her clinical trial interests and experience include epidemiological, observational, and vaccine studies of infectious diseases (including bacterial meningitis, malaria, pneumonia, and tuberculosis) and noncommunicable diseases (including asthma, bronchiectasis, and cystic fibrosis). Dr. Owusu participated in a Phase II pediatric malaria vaccine trial in Ghana.

    Formal Clinical Trial Training*

  • Formal GCP Training

    • Trial Phases

  • Phase II

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2750750/

    Richard O. Phillips, MBChB, Ph.D.

    Honorary Consultant in Infectious Diseases, Komfo Anokye Teaching Hospital; Professor of Medicine, Kwame Nkrumah University of Science and Technology; Scientific Director, Kumasi Centre for Collaborative Research in Tropical Medicine

  • Infectious Diseases

    • Overview

    Prof. Phillips is an Honorary Consultant in Infectious Diseases at Komfo Anokye Teaching Hospital; Professor of Medicine at Kwame Nkrumah University of Science and Technology; and Scientific Director at Kumasi Centre for Collaborative Research in Tropical Medicine. He heads an active research laboratory focused on Buruli ulcer (Mycobacterium ulcerans disease); emerging infectious diseases; HIV co-infections with hepatitis B, C, D, and E viruses; Mansonella perstans filariasis; neglected skin diseases; tuberculosis; and yaws. His clinical trial interests and experience include drug (small molecule), observational, and pediatric studies of Buruli ulcer, HIV, M. perstans filariasis, tuberculosis, yaws, viral hepatitis, and liver cancer.

    Formal Clinical Trial Training*

  • Formal GCP Training

    • Trial Phases

  • Phase II
  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7181188/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709892/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609185/

    https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5795

    https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14534

    https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23991

    *Definitions

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