Www.theglobalhealthnetwork.org THE CHALLENGES OF DIAGNOSTIC AND VACCINE TRIALS Dr. Hennie Geldenhuys...
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Www.theglobalhealthnetwork.org THE CHALLENGES OF DIAGNOSTIC AND VACCINE TRIALS Dr. Hennie Geldenhuys South African Tuberculosis Vaccine Initiative (SATVI),
www.theglobalhealthnetwork.org THE CHALLENGES OF DIAGNOSTIC AND
VACCINE TRIALS Dr. Hennie Geldenhuys South African Tuberculosis
Vaccine Initiative (SATVI), University of Cape Town
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Who is SATVI? >12 years; 19 trials; 9 sponsors Clinical
trial site + TB immunology lab Academic + field staff ( 120) Range
of studies: epi studies, TB vaccine trials, diagnostic, TB
drugs
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Where is the SATVI site?
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www.theglobalhealthnetwork.org Vaccine trials: some challenges
Recruitment and retention Vaccine storage and preparation Adverse
event reporting
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www.theglobalhealthnetwork.org Pearls of recruitment wisdom
Recruitment does not happen in a straight line Recruitment does not
happen by accident Real life happens It is always slower and
tougher than you thought it would be The more you practice, the
luckier you get Gary Player
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Recruitment From: Geldenhuys, Waggie et al. Lessons learnt from
a Poliomyelitis Trial. Vaccine, 2010
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Recruitment DECEMBER HOLIDAY
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www.theglobalhealthnetwork.org Retention in vaccine trials In
preventative vaccine trials participants are healthy- how do we
keep them interested in the trial? Examples: - providing transport
- making the site participant-friendly - relationship with the
study team - pro-actively addressing fears
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www.theglobalhealthnetwork.org Vaccine storage and
accountability: A fridge is not a fridge is not a fridge Vaccine
fridges NB Back-up systems How do you monitor temperature? e.g.
mercury thermometer, min-max, continuous monitoring
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www.theglobalhealthnetwork.org Adverse Event Reporting: keeping
it consistent Examples: - a list of common AE terms - a list of
standard database terms - only do what you are qualified to do - a
system that works AE collection to QC to assessment to capturing to
cleaning
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www.theglobalhealthnetwork.org Diagnostic trials: some
challenges Recruitment Infection control SOPs and standardization
of study procedures Specimen management
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Case Study: A clinical trial comparing induced sputum to
routine sputum for TB diagnosis TB suspects from clinics Sputum
Induction with hypertonic saline Routine sputum collection Early
morning sputum collection Compare yield smear + culture
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www.theglobalhealthnetwork.org Recruitment Liaison with the
healthcare clinics: how to get our job done without interfering
with theirs and without making them our enemies (e.g. training,
incentives, involvement, secondment of staff) Protocol challenges
e.g. getting suspects before they are treated its all in the
timing
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www.theglobalhealthnetwork.org SOPs and how to make them work
Study procedures: - done exactly the same way every time - SOP must
be practical - the importance of training and QC - clinical
practice vs research practice
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www.theglobalhealthnetwork.org Infection control first do no
harm Participants may be infectious e.g. TB disease Patients may be
at risk e.g. HIV + pts Staff members are at risk Methods of
infection control (some examples) - physical cohorting - masks and
gloves - facilities e.g. extractor fans
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www.theglobalhealthnetwork.org Specimen Management Is there a
process that works? What about storage? What about transport? What
about accountability + monitoring ?
