Ahmadu Bello University Teaching Hospital

A126, Ungwan Doka 810105, Shika-Zaria, Nigeria

Public Hospital, University or Academic Center

Serves Western Africa

The Ahmadu Bello University Teaching Hospital (ABUTH) is a public hospital in Zaria, Kaduna State, Nigeria. ABUTH is one of eight federally-funded Cancer Centers of Excellence across Nigeria and serves as a referral center for much of northern Nigeria, including nearby Kano and Katsina states. ABUTH is connected to several international research networks and has previously hosted Phase IV clinical trials for infectious diseases, gynecological conditions, and neonatal conditions.

Links to previous clinical trials:
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=661

https://clinicaltrials.gov/study/NCT03802032

https://clinicaltrials.gov/study/NCT03446937

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: 3-4 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
    -Training in Human Subjects Protection (HSP)
    Research nurseYes
    -Training in Human Subjects Protection (HSP)
    Research data managerYes
    -Training in Human Subjects Protection (HSP)
    Quality assurance managerYes
    BiostatisticiansYes
    Database programmersNo
    EpidemiologistsYes
    -Training in Human Subjects Protection (HSP)
    PathologistsYes
    PharmacistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)

    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:

  • ASLM
  • CDC
  • Medical Laboratory Council of Nigeria

    • 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
  • Other: Mammography, fluoroscopy

    • 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:

  • Hepatitis Vaccine

    • Infectious disease treatment services performed on site:

  • Antimicrobial/antibiotic drugs (small molecules or biologics; including antibacterial, antifungal, antiparasitic, antiviral medicines)
  • Immunotherapies: Convalescent plasma
  • Supportive care/symptom management
  • Surgery
  • Viral load monitoring

    • Investigators at Ahmadu Bello University Teaching Hospital

    Jamilu Faruk Abdullahi, MBBS

    Consultant Pediatric Oncologist

  • Cancer

    • Overview

    Dr. Abdullahi is a Consultant Pediatric Oncologist at Ahmadu Bello University Teaching Hospital. In addition to his MBBS, he has a Master of Public Health (MPH) and a Master of Science in cancer and clinical oncology. His clinical trial interests are in pediatric oncology, with an emphasis on metronomic chemotherapy for advanced childhood cancers. He has been the sub-principal investigator on multiple clinical trials assessing drug safety for patients with sickle cell disease.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal HSP Training

    • Trial Phases

  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    • Trial: Inclacumab drug efficacy and safety study for sickle cell disease patients in Nigeria. Dr. Abdullahi’s role in trial: Sub-Principal Investigator.
    • Trial: Inclacumab drug re-admission study for sickle cell disease patients in Nigeria. Dr. Abdullahi’s role in trial: Sub-Principal Investigator.
    • Trial: Inclacumab long-term safety study for sickle cell disease patients in Nigeria. Dr. Abdullahi’s role in trial: Sub-Principal Investigator.
    Anisah Yahya, MBBS

    Honorary Consultant, Gynecologic Oncology Unit, Department of Obstetrics and Gynecology

  • Cancer

    • Overview

    Dr. Yahya is an Honorary Consultant in the Gynecologic Oncology Unit in the Department of Obstetrics and Gynecology at Ahmadu Bello University Teaching Hospital. In addition to her MBBS, she has a Master of Science in human reproduction, and is currently undergoing International Gynecologic Oncology Society subspecialty training in gynecologic oncology. Her clinical trial interests are in gynecological cancers, especially prevention studies and research to improve treatment outcomes for patients in resource-poor settings with limited access to state-of-the-art therapies.

    Formal Clinical Trial Training*

  • Formal GCP Training

    • Experience Conducting or Participating in Clinical Trials: No

    *Definitions

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