FAM-CRU’s main focus is the conduct of prospective clinical studies. These include innovative clinical trials of treatment strategies for HIV and TB co-infection, pharmacokinetic studies and cohort studies for natural history determination. Vaccine studies include those to prevent TB and other bacterial and viral infections and also as therapeutic interventions.
These studies may be self-initiated, or through clinical trial networks. For the latter, FAM-CRU investigators may contribute to the design of studies in various capacities (chair, co-chair, investigator or sub-investigator).
FAM-CRU investigators may also undertake database explorations and address emerging questions from clinical trials, once the primary objectives have been addressed and after obtaining the relevant permission from sponsors, ethics committees and relevant regulatory bodies. Studies sponsored by pharmaceutical and vaccine companies are also undertaken, provided relevant to FAM-CRU’s overall mission.
There is a wide mix of areas of expertise among senior scientific lead investigators for infectious diseases in the following groups of patients:
a) Infants and children, including premature, low birth weight
b) Pregnancy
c) Adolescence
d) Adults
There is expertise in following domains:
e) Clinical infectious diseases
f) Infection prevention and control
g) Neurocognition
h) Non-communicable diseases
i) Pharmacokinetics
j) Immunology
k) Virology
l) Microbiology
Teaching and Training
Teaching and training for the research teams are ‘in service’ and relevant to the studies undertaken. This consist of start-up meetings and updates around protocols. In addition, topics of general interest and specific for protocol team occupational classes are conducted regularly.
A wide spectrum of training and mentoring is undertaken by FAM-CRU including:
a) Researchers for Masters & PhD degrees (registered in the Department of Paediatrics and Child Health or other departments in the Faculty)
b) In service and protocol-specific training for the following team members:
• Trial doctors
• Project managers
• Professional nurses
• Staff nurses
• Quality assurance officers
• Counsellors
• Data managers
• Data entry officers
• Regulatory officers
• Pharmacists
• Assistant pharmacists
• Social worker
• Counsellors
• Field workers
• Drivers
• Cleaners
• Clerks
Service to community – Service to community
Members of FAM-CRU render service on the following platforms:
a) Clinical service in Tygerberg Children’s Hospital
b) Support to the community health service level and at primary health care facilities through offering ‘state of the art’ care and therapies unavailable to the community and through saving resources through performing routine and specialised assays
c) Service to research community by serving on trial steering committees, endpoint review committees and data safety monitoring boards
d) Service to general community through advisory committees at local, Provincial, National and Global level
Transfer of knowledge into policy and management
a) knowledge transfer to the scientific community and to policy makers through publications and conference presentations
b) dissemination of knowledge to communities where research takes place
c) communication of knowledge to the media
d) advocacy around issues pertinent to TB and HIV
e) Participation in provincial, national and global guideline committees