1. The
Joys
and
Woes
of
Clinical
Trial
Start-­‐Up:
A
Global
Perspec.ve

2. Introduc;on

3. Polling
Ques;on
#1

4. Off
to
the
races!

5. Some
Start-­‐Up
Sta;s;cs
Data
from:
Tu2’s
Center
for
the
Study
of
Drug
Development’s
“Benchmarking
the
Study
Ini.a.on
Process”

6. Polling
Ques;on
#2

7. The
Buck
Starts
Here

8. Running
the
Heats

9. Sizing
up
the
Playing
Field

10. Pre-­‐race
Warm-­‐up
ü Hold
site
accountable
for
feasibility
assessment
responses
ü 2
levels
of
assessment:
– Ini.al
“Interest/Ability”
– Detailed
“Assessment”
ü Follow-­‐up
with
phone
call
ü CRAs
must
know
the
study
– What
is
known
about
study?
Are
addi.onal
steps
needed?
– Are
the
popula.on
and/or
enrollment
numbers
listed
in
their
Feasibility
accurate?
ü Schedule
.me
to
meet
w/Budget
and
Contracts
contacts

11. Entrance
Fee
and
Applica;on

12. The
Winning
Formula

13. Targe;ng
the
Finish
Line

14. Ques;ons?