Baptist Institute of Health Sciences

Mbingo Baptist Hospital, Kom, North West Region, Bamenda, Cameroon

Public Hospital, University or Academic Center

Serves Central Africa

The Baptist Institute of Health Sciences (BIHS) is a private academic center in Bamenda, Cameroon. BIHS is affiliated with the Mbingo Baptist Hospital, a full-service hospital that address a range of therapeutic areas and treats more than 70,000 patients per year from the western and central regions of Cameroon and from Chad, Equatorial Guinea, Gabon, and Central Africa Republic. BIHS has previously hosted clinical trials, including studies on pediatric cancers.

Links to previous clinical trials:

https://sajo.org.za/index.php/sajo/article/view/88

http://www.samj.org.za/index.php/samj/article/view/12109

https://journals.sagepub.com/doi/10.3747/pdi.2017.00190

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: Quarterly

    Application turnaround time (IRB/IEC): 5–6 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 6+ 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 nurseNo
    Research data managerYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    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)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Database programmersYes
    -Experience in Clinical Trials
    EpidemiologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    PathologistsYes
    -Experience in Clinical Trials
    PharmacistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)

    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:

  • None

    • 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: Elastography

    • 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
  • 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:

  • None

    • 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 Baptist Institute of Health Sciences

    Francine Kouya, M.D.

    Supervisor of Clinical Oncology, Mbingo Baptist Hospital/Baptist Institute of Health Sciences

  • Cancer

    • Overview

    Dr. Kouya is the Supervisor of Clinical Oncology at Mbingo Baptist Hospital/Baptist Institute of Health Sciences. Her clinical trial interests and experience include pediatric cancers (Burkitt lymphoma, B-cell lymphoma, Wilms tumor); survivorship; and how practitioners in LMICs can improve patient outcomes and best support cancer survivors. She is currently leading the Cameroon arm of the Collaborative Wilms Tumor Africa Project, a Phase II clinical trial taking place in Cameroon, Ghana, and Malawi.

    Trial Phases

  • Phase II

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://clinicaltrials.gov/study/NCT01991652?locStr=Cameroon&country=Cameroon&cond=Cancer&term=Wilms%20Tumour&rank=1

    Norah Nyah Ndi, MBBS

    Vice Dean of Clinical Affairs, Baptist Institute of Health Sciences; Chief Medical Officer and Internist, Mbingo Baptist Hospital

  • Infectious Diseases

    • Overview

    Dr. Ndi is the Vice Dean of Clinical Affairs at Baptist Institute of Health Sciences, and the Chief Medical Officer and Internist at Mbingo Baptist Hospital. In addition to her MBBS, she is currently in the thesis phase of an MPH program. She has expertise in antiviral therapy and viral load monitoring for infectious diseases. Her clinical trial interests include observational and vaccine studies for hepatitis B and tuberculosis. She has participated in large-scale outpatient studies in Cameroon, with a primary focus on hepatitis B. Dr. Ndi has led a chronic hepatitis B cohort study with her hospital system since 2016.

    Experience Conducting or Participating in Clinical Trials: No

    Signang Alberic Ndonku, Pharm.D.

    Head of Pharmacy

  • Cancer

    • Overview

    Dr. Signang Alberic Ndonku is the Head of Pharmacy at Mbingo Baptist Hospital. He has expertise in medical and pediatric oncology; oncology research; biostatistics; data management; and quality assurance. His clinical trial interests and experience include diagnostic, drug (biologic and small molecule), epidemiological, and observational studies for prostate cancer in men of African descent; breast cancer; and Burkitt lymphoma.

    Formal Clinical Trial Training*

  • Formal GCP Training

    • Trial Phases

  • Phase I
  • Phase III
  • Phase II
  • Phase IV

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    No online documentation

    *Definitions

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