THE CHALLENGES OF DIAGNOSTIC AND VACCINE TRIALS Dr. Hennie Geldenhuys South African Tuberculosis Vaccine Initiative (SATVI), University of Cape Town

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

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

Recruitment From: Geldenhuys, Waggie et al. Lessons learnt from a Poliomyelitis Trial. Vaccine, 2010

Recruitment DECEMBER HOLIDAY

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

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

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

Diagnostic trials: some challenges Recruitment Infection control SOPs and standardization of study procedures Specimen management

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

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

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

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

Specimen Management Is there a process that works? What about storage? What about transport? What about accountability + monitoring ?