Kilimanjaro Clinical Research Institute

M8JH+P4 Majengo, Tanzania

Private research institution

Serves Eastern Africa

The Kilimanjaro Clinical Research Institute (KCRI) is a private research institution in Moshi, Kilimanjaro District, Tanzania. KCRI is part of the Kilimanjaro Christian Medical Center (KCMC), a private hospital with 630 beds and a clinical staff of 1,300, that treats a large population from northern Tanzania, surrounding regions of Tanzania, and southern Kenya. KCRI has previously hosted clinical trials, though these focused on infectious diseases, including HIV and tuberculosis. AC3T’s cancer clinical trials capacity data show that KCRI performs well across all dimensions. KCRI has access to the roughly 5,000 cancer patients treated each year and all the equipment and resources housed at KCMC.

Links to previous clinical trials:
https://clinicaltrials.gov/ct2/show/NCT01494038

https://clinicaltrials.gov/ct2/show/NCT01061151

https://clinicaltrials.gov/ct2/show/NCT03338621

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): 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 typeNumber of staff
    Performs study site coordination and manage daily operational activities5
    Prepares and administers study drug3
    Collects and processes study data and maintain data integrity4
    Monitors site processes and ensures quality3
    Biostatisticians3
    Database programmers3
    Epidemiologists5
    Pathologists3
    Pharmacists6
  • 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:

  • College of American Pathologists (CAP)
  • Clinical Laboratory Improvement Amendments (CLIA)
  • Good Laboratory Practices (GLP)

    • 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

    • 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 Kilimanjaro Clinical Research Institute

    Hadija Hamisi Semvua, Ph.D.

    Head, Clinical Trial Department; Research Scientist; and Project Coordinator, Kilimanjaro Clinical Research Institute; Chief Pharmacist, Kilimanjaro Christian Medical Center

  • Cancer
  • Infectious Diseases

    • Overview

    Dr. Hadija Hamisi Semvua is Head of the Clinical Trial Department, Research Scientist, and Project Coordinator at Kilimanjaro Clinical Research Institute, and Chief Pharmacist at Kilimanjaro Christian Medical Center. She is also the coordinator for community engagement activities sponsored by PanACEA and TB Alliance. In addition to her Ph.D. in pharmacology, Dr. Semvua has a Master of Public Health (MPH) degree. Her clinical trial interests and experience include behavioral, drug (small molecule), and pediatric studies of tuberculosis (including pharmacokinetics and pharmacovigilance); other bacterial infections; HIV; impacts of noncommunicable diseases on antimicrobial drugs; breast cancer; and prostate cancer. She is currently co-principal investigator (PI) for the SimpliciTB study to shorten tuberculosis drug treatment, and PI of a study to evaluate pharmacokinetic safety and tolerability of high-dose rifampicin in children aged 1-14 years with uncomplicated tuberculosis.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal GCLP Training

    • Trial Phases

  • Phase II

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://pmc.ncbi.nlm.nih.gov/articles/PMC9463748

    https://orcid.org/0000-0002-1352-5899

    https://pmc.ncbi.nlm.nih.gov/articles/PMC5159618

    https://pmc.ncbi.nlm.nih.gov/articles/PMC5655063

    *Definitions

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