University of Zimbabwe College of Health Sciences

52RV+556, Harare, Zimbabwe

Public Hospital, University or Academic Center

Serves Southern Africa

The University of Zimbabwe, Faculty of Medicine and Health Sciences (UZFMHS) is an academic center in Harare, Zimbabwe. UZFMHS is affiliated with the Parirenyatwa Group of Hospitals (PGH), the largest medical center in Zimbabwe. PGH is home to the largest of 3 cancer treatment centers in Zimbabwe. UZFMHS oncology services see over 1500 cancer patients annually, with a clinical staff of over 50. UZFMHS has previously hosted clinical trials, including Phase II drug and radiotherapy trials for cervical cancer and non-Hodgkin lymphoma. UZFMHS outsources some of the diagnostic imaging and laboratory services, but AC3T’s cancer clinical trials capacity data show that UZFMHS performs well across many dimensions and has capabilities that are not common at other African hospitals, including Flow Cytometry.

Links to previous clinical trials:

https://clinicaltrials.gov/ct2/show/NCT01590017

https://clinicaltrials.gov/ct2/show/NCT01775475

https://clinicaltrials.gov/ct2/show/NCT03834571

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): 4-8 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 16-20 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
    -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)
    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:

  • Good Laboratory Practices (GLP)

    • 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:

  • Childhood Vaccines
  • Hepatitis B
  • COVID-19
  • Yellow Fever
  • Influenza

    • 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 Zimbabwe College of Health Sciences

    Shirley Chibonda, MBBS, MMed

    Consultant Oncologist, Parirenyatwa Radiotherapy Centre; Adjunct Lecturer, Department of Oncology, Medical Physics, University of Zimbabwe

  • Cancer

    • Overview

    Dr. Chibonda is a Consultant Oncologist at Parirenyatwa Radiotherapy Centre (one of Zimbabwe’s two public radiotherapy centers where systemic therapies are prescribed), as well as an Adjunct Lecturer in the Department of Oncology, Medical Physics at the University of Zimbabwe. She is interested in radiotherapy clinical trials for breast, cervical, pediatric, and prostate cancers. Dr. Chibonda is currently a co-investigator for a study of radiation-induced skin toxicity in breast cancer patients.

    Formal Clinical Trial Training*

  • Formal GCP Training

    • Experience Conducting or Participating in Clinical Trials: No

    Edith Matsikidze, MBChB, MMed

    Consultant Clinical Oncologist, Parirenyatwa Group of Hospitals; Lecturer, Department of Oncology, University of Zimbabwe

  • Cancer

    • Overview

    Dr. Matsikidze is a Consultant Clinical Oncologist at the Parirenyatwa Group of Hospitals and a Lecturer in the Department of Oncology at the University of Zimbabwe, where she teaches undergraduate and post-graduate students training in oncology. She has expertise in pediatric radiotherapy and a passion to improve the quality of oncology research and access to quality cancer treatment in Africa. Her clinical trial interests include behavioral and epidemiological studies of gynecological, HIV-related, and human papillomavirus (HPV)-related malignancies.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal HSP Training

    • Experience Conducting or Participating in Clinical Trials: No

    Tinashe Adrian Mazhindu, MBChB, MMed

    Clinical Research Fellow (DPhil), Department of Oncology, Medical Physics and Imaging Sciences, University of Zimbabwe; Senior Scientist, Clinical Research and Trial Unit, African Institute of Biomedical Science and Technology; Clinical Oncologist, Parirenyatwa Group of Hospitals

  • Cancer

    • Overview

    Dr. Mazhindu is a Clinical Research Fellow (DPhil) in the Department of Oncology, Medical Physics and Imaging Sciences, at the University of Zimbabwe; a Senior Scientist in the Clinical Research and Trial Unit at the African Institute of Biomedical Science and Technology; and a Clinical Oncologist at the Parirenyatwa Group of Hospitals. He also serves as the Southern Africa Co-Lead for the Consortium of Genomics & Therapeutics for Africa (CGTA). In addition to his MBChB and MMed (radiotherapy and oncology) degrees, he completed training in clinical research (drug discovery and translational research) through the Stanford University School of Medicine SPARK Program as a visiting scholar in the Department of Chemical & Systems Biology. His clinical trial interests and experience include differential efficacy and toxicity studies based on germline pharmacogenomic biomarker-guided therapy based on DPYP, CYP2D6, CYP2C19, and UGT1A1 variants in gastrointestinal cancer patients.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal HSP Training

    • Trial Phases

  • Phase I
  • Phase IV
  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://dbds.stanford.edu/events/clinical-implementation-study-of-feasibility-and-effectiveness-of-pharmacogenomically-guided-treatment-in-gastrointestinal-cancer-patients/

    https://www.aacr.org/professionals/research-funding/funded-research/career-development-awards/beginning-investigator-grant-for-catalytic-research-big-cat/

    Ntokozo Ndlovu, MBBS, MMed

    Associate Professor of Clinical Radiation Oncology; Chairperson for Faculty Non-Communicable Diseases Research Group

  • Cancer

    • Overview

    Prof. Ndlovu is Associate Professor of Clinical Radiation Oncology and Chairperson for the Faculty Non-Communicable Diseases Research Group at the University of Zimbabwe. In addition to her MBBS, she has MMed degrees in clinical epidemiology, radiotherapy, and oncology. She is a longstanding academic professional and cancer advocate at home and abroad, with a focus on equity of cancer care delivery. Her professional interests include pharmacogenomics for precision medicine; addressing inequities of radiotherapy treatment delivery in Africa; mentoring young cancer professionals/researchers; and developing institutional treatment and research capacities through collaborative partnerships. Prof. Ndlovu’s clinical trial interests and experience include behavioral, drug (biologic), epidemiological, and observational studies for breast, gastrointestinal, gynecological, prostate, and HIV-associated cancers.

    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://pubmed.ncbi.nlm.nih.gov/30773222/

    https://ascopubs.org/doi/10.1200/GO.20.00152

    https://dbds.stanford.edu/events/clinical-implementation-study-of-feasibility-and-effectiveness-of-pharmacogenomically-guided-treatment-in-gastrointestinal-cancer-patients/

    *Definitions

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