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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. Expansion. New England New York Delaware Valley
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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 1st Yearly Report 9/1999 – 10/2000
CTN Breaking News Expansion
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 6 existing + 8 new nodes87 CTPs in 18 states + DC
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 Expansion2001 - 2002 • Pharmaco + Behavior therapy • Opioid + Stimulant addictions • Baseline about the CTN • Special population • Adolescent • AIDS/HIV & HCV • Court diverted • Co-morbid • Family therapy
CTN DisseminationCTN-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
MET/MI Update 11 February 2001 NODE New England Oregon Pacific Mid-Atlantic New York Delaware Valley MET or MI? MET MI MET MI MI MET # CTPs 2 3 2 1 1 2 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 & 23rd. 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 RAs NA 1 of 2 RAs NA NA 1 of 2 RAs Earliest start date Mid-February March 1 April 1 April 1 Mid-April April 1 • Issues: • IRBitis: Delays associated with multiple submissions. • SDSS still taking about 1 hour on average. • SAEs
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 Challenges-The CTN Way
Don’t Worry Be Happy!