Lagos University Teaching Hospital (LUTH)

Lagos, Nigeria

Public Hospital, University or Academic Center

Serves Western Africa

Over the years the Lagos University Teaching Hospital has remained one of the best Teaching/Specialist Hospitals in the country. The hospital is designated a centre of excellence in Dentistry. The hospital also renders services in specialized areas of Medicine like Neuro-Surgery, Haemo-dialysis, Radiation Oncology, Ophthalmology, Obstetrics and Gynaecology, Cardiothoracic Surgery, Urology, Paediatric Surgery, Maxillofacial Surgery, Ear Nose and Throat Surgery, Haematology, Medical Microbiology, Community Health, Child Dental Health, Restorative Dentistry, Maternal Health, Psychiatry, Orthopaedic Surgery etc. LUTH also boasts of a comprehensive Diagnostic Centre and VIP Clinic, state of the art Laboratories, Radiodiagnosis, Radiotherapy and Renal Dialysis facilities. LUTH is the largest Teaching Hospital in Nigeria with 800 beds and with the College of Medicine of the University of Lagos, LUTH is involved in the training of hundreds of Medical, Dental, Pharmacy and other Allied Health Science Students. The hospital has produced thousands of Nurses, Laboratory Scientists, Health Records Officers, Biomedical Engineers and other para-Medical Cadres. Various members of the Consultant staff have made significant contributions to the advancement of knowledge in major areas of medical science, notably in the separation of conjoined twins and in-vitro fertilization. LUTH partners with private organizations in providing state-of-the-art facilities. The flagship of such partnership is the multi-million dollars Medserve-LUTH Cancer Centre (MLCC), the first of its kind in West Africa.

Links to previous clinical trials:

https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1002/ijgo.13514

https://pubmed.ncbi.nlm.nih.gov/37906618

https://ascopubs.org/doi/10.1200/GO.21.00258?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

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: 7-8 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 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)
    -Training in Good Clinical Laboratory Practice (GCLP)
    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)
    -Training in Good Clinical Laboratory Practice (GCLP)
    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:

  • 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

    • 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:

  • Covid-19
  • Hepatitis
  • BCG
  • MMR
  • HPV
  • Tetanus
  • DPT

    • Infectious disease treatment services performed on site:

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

    • Investigators at Lagos University Teaching Hospital (LUTH)

    Kehinde Okunade, MBBS

    Head, Oncology and Pathological Studies Unit, Department of Obstetrics and Gynecology, Lagos University Teaching Hospital; Associate Professor of Obstetrics and Gynecology, University of Lagos

  • Cancer
  • Infectious Diseases

    • Overview

    Dr. Kehinde Okunade is Head of the Oncology and Pathological Studies Unit in the Department of Obstetrics and Gynecology at Lagos University Teaching Hospital, and Associate Professor of Obstetrics and Gynecology at University of Lagos. In addition to his MBBS degree, he has an MSc in tropical medicine and has completed postdoctoral research training in implementation science, epidemiology, and clinical trials through prestigious programs such as the NIH Fogarty Emerging Global Leader (K43) Award and Janssen Global Public Health Research and Development Fellowship Award. His clinical trial interests and experience include diagnostic, drug (biologic and small molecule), epidemiological, mobile health technology (mHealth), observational, surgical, and vaccine studies for cervical cancer, human papillomavirus (HPV), and HIV. Dr. Okunade also explores the integration of implementation science and digital health innovations to strengthen trial impact and scalability.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal HSP Training

    • Trial Phases

  • Phase I
  • Phase III
  • Phase II

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1002/ijgo.13514

    https://ascopubs.org/doi/10.1200/GO.21.00258?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

    https://bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12538-6

    *Definitions

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