University of Nigeria Teaching Hospital

University of Nigeria Teaching Hospital, Ituku/Ozalla, Enugu

Public Hospital, University or Academic Center

Serves Western Africa

The University of Nigeria Teaching Hospital (UNTH) is a public hospital in Enugu, Enugu State, Nigeria. UNTH is one of eight federally funded Cancer Centers of Excellence across Nigeria, has 700 beds, and serves as a referral center the southeastern and South-south regions of the country. UNTH has previously hosted epidemiological and observational studies in addition to a Phases II and III clinical trials on drug treatment for malaria, vaccine trials and TB drug trials. It has also hosted some investigator-initiated drug trials in Oncology and renal diseases.

Links to previous clinical trials:

https://www.sciencedirect.com/science/article/pii/S0264410X14011773?via%3Dihub

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5492222/

https://clinicaltrials.gov/ct2/show/NCT00344006

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: Quarterly

    Application turnaround time (IRB/IEC): 12 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 12 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)
    Research nurseYes
    Research data managerYes
    Quality assurance managerNo
    BiostatisticiansYes
    -Experience in Clinical Trials
    Database programmersNo
    EpidemiologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    PathologistsYes
    -Experience in Clinical Trials
    -Training in Good Clinical Practice (GCP)
    PharmacistsYes
    -Experience in Clinical Trials

    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:

  • Good Laboratory Practices (GLP)
  • International Organization for Standardization (ISO)

    • 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:

  • DPT
  • Polio
  • Hepatitis B
  • HPV
  • Measles

    • 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 University of Nigeria Teaching Hospital

    Emmanuel Ezeome, MBBS

    Head, Division of General Surgery/Surgical Oncology, and Consultant Surgical Oncologist, University of Nigeria Teaching Hospital; Director, Bioethics Program, Institute of Public Health, University of Nigeria

  • Cancer

    • Overview

    Dr. Ezeome is a Professor of Surgery and Consultant Surgical Oncologist at the University of Nigeria Teaching Hospital and the Director of the Bioethics Program at the University of Nigeria’s Institute of Public Health. In addition to his MBBS, he has a master’s degree in bioethics and expertise in data management. His clinical trial interests and experience include surgical oncology, breast surgery, clinical oncology (including biologic and small-molecule drug studies), cancer epidemiology, and cancer control. He also has an active grant-funded program in biomedical ethics research and training, including informed consent, data science ethics, genomic ethics, and clinical ethics.

    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://clinicaltrials.gov/study/NCT00344006

    *Definitions

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