Transcript The challenges of diagnostic and vaccine trials Dr. Hennie

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