Queen Elizabeth Central Hospital

52XC+47J, Blantyre, Malawi

Public hospital

Serves Eastern Africa

The Queen Elizabeth Central Hospital (QECH) is a public hospital in Blantyre, Malawi. QECH has previously hosted clinical trials, some focused on infectious diseases such as Malaria and Typhus and a trial focused on cervical cancer. AC3T’s cancer clinical trials capacity data show that QECH performs well across all dimensions; though the hospital currently lacks certain imaging, diagnostic laboratory, and radiotherapy capabilities.

Links to previous clinical trials:

https://clinicaltrials.gov/ct2/show/NCT03299426

https://clinicaltrials.gov/ct2/show/NCT00522132

https://clinicaltrials.gov/ct2/show/NCT01660672

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: 3 months

    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 activities0
    Prepares and administers study drug0
    Collects and processes study data and maintain data integrity3
    Monitors site processes and ensures quality1
    Biostatisticians0
    Database programmers0
    Epidemiologists0
    Pathologists2
    Pharmacists0
  • 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:

  • International Organization for Standardization (ISO)

    • 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
  • Other: Malaria

    • 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 Queen Elizabeth Central Hospital

    Nginache Nampota-Nkomba, MBBS

    Clinical Research Investigator

  • Infectious Diseases

    • Overview

    Dr. Nampota-Nkomba is a Clinical Research Investigator at Queen Elizabeth Central Hospital. In addition to her MBBS, she has master’s degrees in vaccinology, drug development, and epidemiology, and is currently pursuing a Ph.D. She is interested in vaccine-preventable infectious diseases. During her Ph.D. program, she aims to generate evidence to (1) support the decision-making processes of vaccine policymakers and (2) answer questions concerning current levels of vaccine-mediated protection (by age and location); concomitant disease burdens; vaccine availability; and whether vaccination schedules are conducive to uptake. Her clinical trial interests and experience include vaccine, drug (small molecule), epidemiological, and observational studies for adult and pediatric infectious diseases. Dr. Nampota-Nkomba has worked on clinical trials for a typhoid vaccine candidate and multiple drug trials for malaria.

    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://clinicaltrials.gov/study/NCT03299426

    https://clinicaltrials.gov/study/NCT01650558

    https://www.clinicaltrials.gov/study/NCT05478720

    *Definitions

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