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THE CHALLENGES OF DIAGNOSTIC AND VACCINE TRIALS Dr. Hennie Geldenhuys South African Tuberculosis Vaccine Initiative (SATVI), University of Cape Town www.theglobalhealthnetwork.org 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 Where is the SATVI site? Vaccine trials: some challenges • Recruitment and retention • Vaccine storage and preparation • Adverse event reporting 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 www.theglobalhealthnetwork.org Recruitment 0 200 400 600 800 Cumulative Total of Recruitment and Enrolment 1 2 3 4 5 6 7 8 9 10 11 Duration of trial in months 12 13 14 15 Expectant mothers consented Actual enrolments of newborns Forecast enrolments of newborns From: Geldenhuys, Waggie et al. Lessons learnt from a Poliomyelitis Trial. Vaccine, 2010 Recruitment 90 E N R O L L E D P A R T I C I P A N T S 80 DECEMBER HOLIDAY 70 60 50 40 30 20 10 SAFETY PAUSE 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 WEEK Retention in vaccine trials In preventative vaccine trials participants are healthyhow 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 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 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 www.theglobalhealthnetwork.org Diagnostic trials: some challenges • • • • Recruitment Infection control SOPs and standardization of study procedures Specimen management www.theglobalhealthnetwork.org Case Study: A clinical trial comparing induced sputum to routine sputum for TB diagnosis Sputum Induction with hypertonic saline TB suspects from clinics Routine sputum collection Early morning sputum collection Compare yield smear + culture 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 – it’s all in the timing 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 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 www.theglobalhealthnetwork.org Specimen Management Is there a process that works? What about storage? What about transport? What about accountability + monitoring ? www.theglobalhealthnetwork.org