Transcript Integrating Services Research into CTN Clinical Trials: The Synergy

Integrating Services Research
into CTN Clinical Trials:
The Synergy
Devil is in the Details
Harold I Perl, PhD
Center for the Clinical Trials Network
National Institute on Drug Abuse
Addiction Health Services Research Conference
October 16, 2007
Athens, GA
Why Do HSR in CTN?
 CTN
blends skill and experience of two
key groups of experts
– community-based treatment providers
– academic researchers
 Diverse
and extensive network interested
in developing and participating in research
on critical public health issues
 Incorporating HSR into existing clinical
trials can be resource-efficient
Why Do HSR in CTN Now?
 Blue
Ribbon Task Force on HSR in NIDA
– Recommended closer collaboration with CTN
 DESPR/SRB
enthusiastic to support
– Supplements to collect baseline/pilot data for
future R01 applications
 Current
cadre of CCTN staff with expertise,
experience, and interest in HSR
 Opportunities to participate as new clinical
trials are planned and conducted
Bringing HSR into a Clinical Trial
Already “In-the-Field”
– Prescription Opioid Addiction
Treatment Study
 2 medication management models of
varying length, complexity, and expense
 Twice-weekly individual drug counseling
added to standard medical management
 2-Phase design:
 POATS
1.Initial 4-week treatment with taper
2.12-week stabilization program plus 4-week taper
POATS - CE
 Collect
data to calculate the incremental
cost-effectiveness ratio of enhanced
treatment compared with standard
 Cost estimates comprehensive in scope
including
– Facility/program level
– Treatment staff level
– Participant level
 Follow-on
R01 application expected
POATS - CE
 Protocol
lead team very interested in cost
effectiveness
– Key part of recent competing continuation
application for Node
 NIDA
protocol coordinator also interested in
cost effectiveness
 Existing relationship between protocol lead
team and Brandeis team
POATS - CE
Expertise and enthusiasm of key players
essential to making this work
– Created liaisons at staff level as well as study managers
– “Desired” assessment package cut down to fit reality
– Approached CTPs already recruiting participants and
those about to start
– Small supplement budget required innovative ways
provide incentives to CTPs
– Involved CTN data and clinical coordinating centers
– Shared vision did not guarantee shared understanding
between teams -- needed flexibility and realistic
expectations from all
Bringing HSR into a Clinical Trial
During “Early Planning”
 HIV/AIDS
Rapid Testing protocol
 Studying impact of on-site rapid testing,
HIV-status counseling, or referral to off-site
testing in drug treatment programs
 Development team sees it as promising
vehicle for cost-effectiveness analyses
 Protocol design still in initial phases
 Actual integration of HSR as yet unclear
Bringing HSR into a Clinical Trial
in “Advanced Development”
 STAGE-12
 Combined
group/individual treatment for
stimulant abusers to facilitate engagement
in 12-step groups
 Protocol lead team approached by members
of CTN HSR Special Interest Group
 STAGE-12 leaders interested in questions of
implementation and sustainability
 NIDA protocol coordinator HSR-experienced
STAGE-12 - HSR
 Existing
relationship among key players
– HSR team already part of CTN family
 HSR
investigators invited to participate in
weekly protocol development calls
 Direct negotiations with CTN Data and
Clinical Coordinating Centers
 Contributed to design of main study as well
as HSR component
STAGE-12 - HSR
 Examining
organizational and counselor
variables that may affect implementation
 Monitoring impact on sustainability in CTPs
following clinical trial completion
 Collecting baseline data prior to STAGE-12
trial initiation
 Developing future R01 application to
– conduct secondary analyses
– evaluate implementation and fidelity of
STAGE-12 intervention during and after trial
STAGE-12 - HSR
 Integrating
HSR into main STAGE-12 trial
– Extensive participation of HSR team in planning
process
– Overlap of assessment packages allowed
streamlining in data collection process
 Alignment
of informed consent across studies
 HSR team collecting counselor-level data to be used by
main trial
 STAGE-12 trial providing treatment tapes to HSR team
for fidelity analyses
 Full
integration and enthusiastic cooperation does
not guarantee smooth implementation!
How You Can Join the Fun
Contact SRB staff to discuss options for
collaborating with current or future CTN trial
 Apply for RPG funding under existing FOA

– Health Services Research on Practice Improvement
Utilizing Community Treatment Programs within the
National Drug Abuse Clinical Trials Network (CTN)
– Dissemination and Implementation Research in
Health

Download and analyze public use datasets from
CTN data share website
– www.ctndatashare.org
– 10 datasets currently available
– More to follow as completed