CTN Update Betty Tai, Ph.D February 14, 2001
Who could want a more lovely way To spend Valentine’s Day Than talking about how we may Implement protocols the CTN way
NIDA CTN 1 st Yearly Report 9/1999 – 10/2000
CTN Breaking News Expansio n
6 existing + 8 new nodes 87 CTPs in 18 states + DC New England New York Delaware Valley Mid-Atlantic Pacific Region Oregon Long Island North Carolina South Carolina Florida Great Lakes Ohio Valley Rocky Mountain Washington
CTN Headline News Bup/Nx Detox CTN 002 – start enrollment Jan, 2001, 6 sites CTN 001 – start enrollment Feb, 2001, 6 sites CTN 003 –summer enrollment, 14 sites MET/MI CTN 004 – Pilot patients start Dec,2000, 6 sites CTN 005 – Pilot patients start Jan,2001, 5 sites MI CTN 006, 007 – Pilot patients start today, 14 sites
Current Research Activities Under Development Baseline Study Plan Smoking Cessation Protocol Bup/NX for Adolescent Focused After-care HCV Evaluation Plan
Research Agenda Expansion Pharmaco + Behavior therapy Opioid + Stimulant addictions Baseline about the CTN Special population Adolescent AIDS/HIV & HCV Court diverted Co-morbid Family therapy
CTN Dissemination CTN-Foundation for Cultural Exchange Formed CTN Sub-Committee Intra-CTN Dissemination Training – Skill Dissemination Plain Language Translated Protocols CTN Annual Meetings Extra-CTN Dissemination Publications of Research Results CTN Symposia/Workshops NIDA OSPC “Blending” Meetings CSAT ATTC Collaboration with National, State, Regional Groups Adoption of Tested Therapies
CTN Web
MET/MI Update 11 February 2001 NODENew England OregonPacificMid- Atlantic New YorkDelaware Valley MET or MI? METMIMETMI MET # CTPs IRB approval status Pending ( ) minor revisions Training Therapist MET/MI training completed? Scheduled March 1 & 2 (Haight), 6 & 8 (Tarzana) Scheduled Feb. 7 & 8 Scheduled March 22 & 23 rd. Rescheduled Training/pilot cases enrolled? Therapists certified in MET/MI? Certification tapes being reviewed, 1 therapist credentialed Ongoing Node GCP training completed? Node ASI training completed? Scheduled Scheduled March 8 & 9 SDSS tapes reviewed (MET only) 1 of 2 RAsNA1 of 2 RAsNA 1 of 2 RAs Earliest start date Mid-FebruaryMarch 1April 1 Mid-AprilApril 1 Issues: IRBitis: Delays associated with multiple submissions. SDSS still taking about 1 hour on average. SAEs
Challenges-The CTN Way Partnership Common Language Feasibility Compatibility Acceptability “Words you don’t normally associate with clinical trials”
Challenges-The CTN Way On Multiple Multi-site Trials Communication Standardization/QA Team work Portfolio management Equitable resource allocation
Don’t Worry Be Happy!