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Betty Tai, Ph.D. Betty Tai, Ph.D. February 3, 2010 February 3, 2010 Director Director Center for the Clinical Trials Network Center for the Clinical Trials Network National Institute on Drug Abuse National Institute on Drug Abuse NATIONAL INSTITUTE ON DRUG ABUSE NIDA NIDA Drug Abuse Treatment Clinical NIDA Drug Abuse Treatment Clinical Trials Network Trials Network The First Decade The First Decade

Betty Tai, Ph.D . February 3, 2010 Director Center for the Clinical Trials Network

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NIDA. NATIONAL INSTITUTE ON DRUG ABUSE. NIDA Drug Abuse Treatment Clinical Trials Network The First Decade. Betty Tai, Ph.D . February 3, 2010 Director Center for the Clinical Trials Network National Institute on Drug Abuse. Institute of Medicine, 1998. NIDA Clinical Trials Network. - PowerPoint PPT Presentation

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Page 1: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Betty Tai, Ph.D.Betty Tai, Ph.D.February 3, 2010 February 3, 2010

DirectorDirector

Center for the Clinical Trials NetworkCenter for the Clinical Trials Network

National Institute on Drug AbuseNational Institute on Drug Abuse

NATIONAL INSTITUTEON DRUG ABUSE

NIDA

NIDA Drug Abuse Treatment Clinical Trials NetworkNIDA Drug Abuse Treatment Clinical Trials NetworkThe First DecadeThe First Decade

Page 2: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Research Practice

Research Practice

BridgingtheGap

BridgingtheGap

Institute of Medicine,Institute of Medicine,19981998

Institute of Medicine,Institute of Medicine,19981998

Page 3: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN PremisesCTN PremisesCTN PremisesCTN Premises

• Addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs,

• Randomized, controlled clinical trials are the gold standard for generating evidence-based treatments,

• Engage the providers in the research process will improve the acceptability/adoption of research results.

• Addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs,

• Randomized, controlled clinical trials are the gold standard for generating evidence-based treatments,

• Engage the providers in the research process will improve the acceptability/adoption of research results.

B. Tai B. Tai 20092009B. Tai B. Tai 20102010

Page 4: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Council Report2/3/2010

Council Report2/3/2010

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

B. Tai B. Tai 20102010

Page 5: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

National Drug Abuse Treatment National Drug Abuse Treatment Clinical Trials NetworkClinical Trials Network

Oregon/Hawaii NodeOregon/Hawaii NodeOHSUOHSU

Pacific NorthwestPacific Northwest NodeNode

U. WashingtonU. Washington

Pacific NodePacific NodeUCLAUCLA

Texas NodeTexas NodeUT/S. Med CenterUT/S. Med Center

Florida NodeFlorida NodeU. MiamiU. Miami

Appalachian Appalachian Tri-State NodeTri-State Node

WPIC/U of Pitt.WPIC/U of Pitt.

Ohio Valley NodeOhio Valley NodeU. CincinnatiU. Cincinnati

Southern ConsortiumSouthern Consortium NodeNodeMUSCMUSC

California/Arizona NodeCalifornia/Arizona NodeUCSF/U. ArizonaUCSF/U. Arizona

Southwest NodeSouthwest NodeU. New MexicoU. New Mexico

Northern NE NodeNorthern NE NodeMcLean/HarvardMcLean/Harvard

New England NodeNew England NodeYaleYale

New York NodeNew York NodeNYUNYU

Long Island NodeLong Island NodeNY State Psych. Inst.NY State Psych. Inst.

Delaware Valley NodeDelaware Valley NodeU. PennsylvaniaU. Pennsylvania

Mid-Atlantic NodeMid-Atlantic NodeJHU/MCVJHU/MCV

16 RRTCs & 240 CTPs across 37 States and Puerto Rico16 RRTCs & 240 CTPs across 37 States and Puerto Rico16 RRTCs & 240 CTPs across 37 States and Puerto Rico16 RRTCs & 240 CTPs across 37 States and Puerto RicoB. Tai B. Tai 20102010

Page 6: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

National Drug Abuse Treatment National Drug Abuse Treatment Clinical Trials NetworkClinical Trials Network

Regional Research and Training Center (RRTC) State with Community Treatment Program (CTP)

Page 7: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

The Drug Abuse Treatment CommunityThe Drug Abuse Treatment Community                                                                                           

Rehab Centers

Betty Ford CenterHazelden Foundation

Caron Foundation

Social Model Behavioral Model Medical Model

HospitalsKaiser Permanente

VA HospitalsMayo Clinic

Mercy HospitalRWJ Medical Center

“Drug free programs”Odyssey House

Center for Drug-Free LivingWalden House, Phoenix House

Na’Nizhoozi CenterHomeward Bound

Methadone ClinicsEvergreen Treatment Services

Addiction Research & Treatment Corp.Bi-Valley Medical Clinic

Hartford Dispensary

B. Tai B. Tai 20102010

Page 8: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Coordinating Centers

Organizational design of a multisite trial is as Organizational design of a multisite trial is as important to its success as is the experimental important to its success as is the experimental design. design.

Curtis Meinert, Controlled Clinical Trials 1, 305 (1981)Curtis Meinert, Controlled Clinical Trials 1, 305 (1981)

B. Tai B. Tai 20102010

““Science and process are equally important to Science and process are equally important to ensure success of large prospective studiesensure success of large prospective studies

Timothy Sprosen, UK BiobankTimothy Sprosen, UK BiobankNIH New Models for Large Prospective Studies symposium (1/22/2010) NIH New Models for Large Prospective Studies symposium (1/22/2010)

Page 9: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Coordinating Centers

CTN Data and Statistics CentersCTN Data and Statistics Centers

• Provide statistical support for Provide statistical support for protocol design/analysis protocol design/analysis

• Provide data management via Provide data management via electronic data captureelectronic data capture

• Monitor integrity and security of dataMonitor integrity and security of data

CTN Clinical Coordinating Center• Provide centralized regulatory support, trial monitoring, training in clinical trials implementation

procedures

• Uniform handling of pharmaceuticals, laboratory and clinical supplies

B. Tai B. Tai 20102010

Page 10: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

B. Tai B. Tai 20102010

Page 11: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Council Report2/3/2010

Council Report2/3/2010

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

B. Tai B. Tai 20102010

Page 12: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Pending, Pending, Development & Development &

ReviewReview

Pending, Pending, Development & Development &

ReviewReview

Data Data CollectionCollection

Data Data CollectionCollection Data AnalysisData AnalysisData AnalysisData Analysis Publication & Publication &

DisseminationDisseminationPublication & Publication & DisseminationDissemination

CTN 0027CTN 0031CTN 0032

CTN 0027CTN 0031CTN 0032

CTN 0014CTN 0028CTN 0030

CTN 0014CTN 0028CTN 0030

CTN 0022CTN 0023CTN 0024CTN 0025CTN 0026CTN 0037CTN 0044CTN 0046CTN 0047CTN 0048

CTN 0022CTN 0023CTN 0024CTN 0025CTN 0026CTN 0037CTN 0044CTN 0046CTN 0047CTN 0048

The CTN Trials (1999-now)The CTN Trials (1999-now)

Pharmacotherapies: 12Behavioral Interventions: 14HIV/HCV Interventions: 4Others: 3

Pharmacotherapies: 12Behavioral Interventions: 14HIV/HCV Interventions: 4Others: 3

B. Tai B. Tai 20102010

Page 13: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Randomized Participants

Peer-Reviewed ArticlesCompleted Trials

A Decade of A Decade of Growth: Growth: CTN by the CTN by the (Cumulative) (Cumulative) NumbersNumbers

B. Tai B. Tai 20102010

Page 14: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Studies in DevelopmentCTN Studies in Development

• STRIDE (CTN 0037):STRIDE (CTN 0037):– Stimulant Reduction Intervention Using Dosed Exercise Stimulant Reduction Intervention Using Dosed Exercise

• Web-delivery of Evidence-Based, Psychosocial Treatment Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders (CTN 0044) for Substance Use Disorders (CTN 0044)

• S-CAST (CTN 0046) S-CAST (CTN 0046) – Smoking Cessation and Stimulant TreatmentSmoking Cessation and Stimulant Treatment

• SMART-ED (CTN 0047)SMART-ED (CTN 0047)– Screening, Motivational Assessment, Referral and Treatment in Screening, Motivational Assessment, Referral and Treatment in

Emergency DepartmentsEmergency Departments

• CURB (CTN 0048)CURB (CTN 0048)– Cocaine Use Reduction with BuprenorphineCocaine Use Reduction with Buprenorphine

B. Tai B. Tai 20092009

Page 15: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Highlighting CTN Highlighting CTN Pharmacological Therapy Trials

Highlighting CTN Highlighting CTN Pharmacological Therapy Trials

• Buprenorphine (Suboxone) Buprenorphine (Suboxone)

– CTN 0001, 0002 Bup/Nx vs Clonidine in detoxCTN 0001, 0002 Bup/Nx vs Clonidine in detox

– CTN 0027 Bup/Nx vs Methadone in maintenanceCTN 0027 Bup/Nx vs Methadone in maintenance

– CTN 0010 Bup/Nx for adolescents taperingCTN 0010 Bup/Nx for adolescents tapering

– CTN 0030 Bup/Nx for prescription opiate dependenceCTN 0030 Bup/Nx for prescription opiate dependence

• Osmotic-Release Methylphenidate (Concerta)Osmotic-Release Methylphenidate (Concerta)

– CTN 0029 Adult smokersCTN 0029 Adult smokers

– CTN 0028 Adolescents Substance usersCTN 0028 Adolescents Substance users

• Nicotine replacement in drug treatmentNicotine replacement in drug treatment

– CTN 0009CTN 0009

– CTN 0029CTN 0029

• Buprenorphine (Suboxone) Buprenorphine (Suboxone)

– CTN 0001, 0002 Bup/Nx vs Clonidine in detoxCTN 0001, 0002 Bup/Nx vs Clonidine in detox

– CTN 0027 Bup/Nx vs Methadone in maintenanceCTN 0027 Bup/Nx vs Methadone in maintenance

– CTN 0010 Bup/Nx for adolescents taperingCTN 0010 Bup/Nx for adolescents tapering

– CTN 0030 Bup/Nx for prescription opiate dependenceCTN 0030 Bup/Nx for prescription opiate dependence

• Osmotic-Release Methylphenidate (Concerta)Osmotic-Release Methylphenidate (Concerta)

– CTN 0029 Adult smokersCTN 0029 Adult smokers

– CTN 0028 Adolescents Substance usersCTN 0028 Adolescents Substance users

• Nicotine replacement in drug treatmentNicotine replacement in drug treatment

– CTN 0009CTN 0009

– CTN 0029CTN 0029

B. Tai B. Tai 20102010

Page 16: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Pharmacotherapy Trials CTN 0010

Context:• Increased heroin and pharmaceutical opioid

use among 12th graders• Usual Tx for Opioid addicted youth: Detox and counseling• First RCT study of continued agonist Tx in this young population

Bup/NX 12 weeks

Detox only

B. Tai B. Tai 20102010

Page 17: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Highlighting Highlighting CTN Behavioral Therapy TrialsCTN Behavioral Therapy Trials

• MI or CM: Lower cost motivational incentives

• MI/MET: Motivational interviewing & enhancement– Adults, pregnant women, Spanish speakers

• Seeking Safety: trauma counseling for women

• BSFT: Brief Strategic Family Therapy– Adolescent

• STAGE-12: Twelve Step Facilitation Therapy

• Reducing HIV/HCV risk behavior

– Injection drug use, sex risks for women & men

• MI or CM: Lower cost motivational incentives

• MI/MET: Motivational interviewing & enhancement– Adults, pregnant women, Spanish speakers

• Seeking Safety: trauma counseling for women

• BSFT: Brief Strategic Family Therapy– Adolescent

• STAGE-12: Twelve Step Facilitation Therapy

• Reducing HIV/HCV risk behavior

– Injection drug use, sex risks for women & men

B. Tai B. Tai 20092009

Page 18: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

MET for Spanish-Speaking Substance UsersCTN 0021

B. Tai B. Tai 20102010

Page 19: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Study Challenges and Opportunities Study Challenges and Opportunities CTN 0021CTN 0021

• Recruited 436 representative population of US Recruited 436 representative population of US Hispanics across 5 CTP sites Hispanics across 5 CTP sites

• Bilingual investigators/therapists/RAs Bilingual investigators/therapists/RAs • Translation of 70% of project materialsTranslation of 70% of project materials

– Consent formsConsent forms– CRFsCRFs– Assessment instrumentsAssessment instruments– Intervention manualIntervention manual

• Bilingual Training and fidelity monitoring Bilingual Training and fidelity monitoring

• Shovel ready project for Spanish language Shovel ready project for Spanish language international collaborationinternational collaboration

B. Tai B. Tai 20102010

Page 20: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN 0032: HIV Rapid Testing and Counseling in Drug Treatment

CTN 0032: HIV Rapid Testing and Counseling in Drug Treatment

Recruitment and

Enrollment

Brief Baseline

Assessment

-

Offer Rapid Testing with RESPECT

Counseling

Random Assignment

Client post-intervention data collection

Offer Rapid Testing with Minimal Counseling

Offer Referral for Testing in Community

What is the more effective testing strategy to ensure they get HIV tested and receive their results?

What is the more effective testing strategy to ensure they get HIV tested and receive their results?

What is the more effective testing strategy to reduce their risk behaviors?

What is the more effective testing strategy to reduce their risk behaviors?

First participant randomized: 01/05/2009 Last participant completed 12/31/2009

Total Participants Randomized: 1281

B. Tai B. Tai 20102010

Page 21: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Node initiated exploratory studies to develop collaborations with tribes and Native American treatment programs to explore methamphetamine use and co-occurring problems:

Southwest NodeOhio Valley NodePacific Northwest NodeOregon Hawaii Node

Page 22: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Ancillary StudiesCTN Ancillary Studies

• Cost analysis (NIDA DESPR: Services Research Branch)– CTN 0004, 0005, 0006, 0007, 0010, 0030, 0032, 0046

• Genetics – (NIDA Genetics Consortium) – CTN 0027

• Training methods (NIDA DCNBR: Behavioral & Integrative Treatment Research Branch)

– CTN 0014• Psychometric study (NIAAA)

– CTN 0031 • Brain Imaging study (NIDA DCNBR: Clinical

Neuroscience Branch)– CTN 0030

• Cost analysis (NIDA DESPR: Services Research Branch)– CTN 0004, 0005, 0006, 0007, 0010, 0030, 0032, 0046

• Genetics – (NIDA Genetics Consortium) – CTN 0027

• Training methods (NIDA DCNBR: Behavioral & Integrative Treatment Research Branch)

– CTN 0014• Psychometric study (NIAAA)

– CTN 0031 • Brain Imaging study (NIDA DCNBR: Clinical

Neuroscience Branch)– CTN 0030

B. Tai B. Tai 20102010

Page 23: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Ancillary Studies CTN 0031: STAGE-12

• CTN 0031 A-1CTN 0031 A-1– Identify the association between performance and Identify the association between performance and

neurotoxic oxidative stress level neurotoxic oxidative stress level (by measuring antioxidants (by measuring antioxidants parameters in the plasma) parameters in the plasma)

• CTN 0031 A-2CTN 0031 A-2 – Validate the concept that Validate the concept that frequency of risk drinking patternsfrequency of risk drinking patterns

a predictor for severity of AUDs in a clinical populationa predictor for severity of AUDs in a clinical population

• CTN 0031 A-3CTN 0031 A-3 – Identify Identify organizational and counselor level organizational and counselor level factors that may factors that may

impact the implementation process and possible adoption of impact the implementation process and possible adoption of STAGE-12STAGE-12

B. Tai B. Tai 20092009

Page 24: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Secondary Analysis StudiesCTN Secondary Analysis Studies

• Scientific RationaleScientific Rationale– Secondary clinically useful informationSecondary clinically useful information

– E.G. Who drops out when E.G. Who drops out when

– Mediators and moderators and their interactions at baselineMediators and moderators and their interactions at baseline

• Scientist RationaleScientist Rationale– Investigators (especially junior) benefitInvestigators (especially junior) benefit– A platform for independent research supportA platform for independent research support– Training opportunities (e.g., K Awards)Training opportunities (e.g., K Awards)

• Economic RationaleEconomic Rationale– Inexpensive methods to address important questions Inexpensive methods to address important questions – More precisely define future research steps More precisely define future research steps – Shorten measures to save future costsShorten measures to save future costs

• Scientific RationaleScientific Rationale– Secondary clinically useful informationSecondary clinically useful information

– E.G. Who drops out when E.G. Who drops out when

– Mediators and moderators and their interactions at baselineMediators and moderators and their interactions at baseline

• Scientist RationaleScientist Rationale– Investigators (especially junior) benefitInvestigators (especially junior) benefit– A platform for independent research supportA platform for independent research support– Training opportunities (e.g., K Awards)Training opportunities (e.g., K Awards)

• Economic RationaleEconomic Rationale– Inexpensive methods to address important questions Inexpensive methods to address important questions – More precisely define future research steps More precisely define future research steps – Shorten measures to save future costsShorten measures to save future costs

B. Tai B. Tai 20102010

Page 25: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Do Treatment Improvements in PTSD Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? Severity Affect Substance Use Outcomes? A A Secondary Analysis Secondary Analysis From a Randomized From a Randomized Clinical Trial in NIDA’s Clinical Trials Clinical Trial in NIDA’s Clinical Trials NetworkNetwork

Denise A. Hien et al.Denise A. Hien et al.American Journal of PsychiatryAmerican Journal of PsychiatryJanuary 2010, Vol. 167, No. 1, 95-101 January 2010, Vol. 167, No. 1, 95-101

B. Tai B. Tai 20102010

Page 26: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Conclusions/ImplicationsConclusions/Implications

• PTSD severity reductions were associated with SUD PTSD severity reductions were associated with SUD improvement improvement

• Integrated PTSD/SUD treatments may be Integrated PTSD/SUD treatments may be advantageous for patients with severe symptomsadvantageous for patients with severe symptoms

• For further study:For further study:

– Men, mixed populationsMen, mixed populations

– Combat/military traumaCombat/military trauma

– Other forms of integrated treatmentOther forms of integrated treatment

Hein et al AJP Jan 2010, 167, 1, 95-101 AJP Jan 2010, 167, 1, 95-101 B. Tai B. Tai 20102010

Page 27: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Providing Implications for Providing Implications for PracticePractice

Back, SE Am J Psychiatry 167:1, January 2010B. Tai B. Tai 20102010

Page 28: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Alcohol -- Item Characteristic Curves

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Larger Amounts

Cut Down

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Giving Up

Continued Use

Figure 1

Marijuana -- Item Characteristic Curves

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Larger Amounts

Cut Down

Time Spent

Giving Up

Continued Use

B. Tai B. Tai 20102010

Page 29: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Council ReportCouncil Report2/3/20102/3/2010

Council ReportCouncil Report2/3/20102/3/2010

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

B. Tai B. Tai 20102010

Page 30: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Research Utilization Research Utilization

Process through which research findings are put in use in the form of programs and policies

Process through which research findings are put in use in the form of programs and policies

• DifficultDifficult

• SlowSlow

• Not an action that begins when research is Not an action that begins when research is completedcompleted

• Rather a two way concurrent processRather a two way concurrent process

Everett Rogers, Everett Rogers, Diffusion of InnovationsDiffusion of Innovations, 2003, 2003

Page 31: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

CTN Research Utilization ActivitiesCTN Research Utilization Activities

• Led by CTN Research Utilization CommitteeLed by CTN Research Utilization Committee

• Coordinate intra-CTN and intra-Node activitiesCoordinate intra-CTN and intra-Node activities

• Support and monitor the CTN dissemination library Support and monitor the CTN dissemination library utilizationutilization

• Serve as point of contact for Serve as point of contact for – NIDA Blending ConferenceNIDA Blending Conference

– SAMHSA ATTC ProgramSAMHSA ATTC Program

• Major regional workshops in 2009Major regional workshops in 2009– June 2009 Pacific Region (Portland, Oregon)June 2009 Pacific Region (Portland, Oregon)

– October 2009 Appalachian Tri-state (Pittsburgh, Pa)October 2009 Appalachian Tri-state (Pittsburgh, Pa)

– November 2009 Southern Consortium (Charlotte, SC)November 2009 Southern Consortium (Charlotte, SC)

B. Tai B. Tai 20102010

Page 32: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

• Housed and maintained by Washington Node Housed and maintained by Washington Node

• Inaugural year 2003Inaugural year 2003

• Library usage statistics Library usage statistics

• Housed and maintained by Washington Node Housed and maintained by Washington Node

• Inaugural year 2003Inaugural year 2003

• Library usage statistics Library usage statistics

YEAR Visitors Documents requested

Publications added

2009 11,592 344 39

2008 10,489 77 36

2007 8,644 19 33

2006 4,459 17 18

2005 1,003 NA 2

B. Tai B. Tai 20102010

The CTN Dissemination Libraryhttp://ctndisseminationlibrary.org

The CTN Dissemination Libraryhttp://ctndisseminationlibrary.org

Page 33: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

BuprenorphineBuprenorphineTreatment: ATreatment: ATraining forTraining forMulti-Multi-disciplinarydisciplinaryAddictionAddictionProfessionalsProfessionals

Short-TermShort-TermOpioidOpioidWithdrawalWithdrawalUsingUsingBuprenorphineBuprenorphine

NIDA-SAMHSA Blending Productswww.attcnetwork.org/explore/priorityareas/science/blendinginitiative/index.asp

NIDA-SAMHSA Blending Productswww.attcnetwork.org/explore/priorityareas/science/blendinginitiative/index.asp

MMotivationalotivationalIInterviewingnterviewingAAssessment:ssessment:SSupervisoryupervisoryTTools forools forEEnhancingnhancingPProficiencyroficiency(MIA-STEP)(MIA-STEP)

PPromotingromotingAAwareness ofwareness ofMMotivationalotivationalIIncentivesncentives(PAMI)(PAMI)

Promoting Awareness of Motivational Incentives (PAMI)

TreatmentTreatmentPlanningPlanningMATRS: Utilizing MATRS: Utilizing the Addiction the Addiction Severity Index Severity Index (ASI) to Make (ASI) to Make Required Data Required Data Collection UsefulCollection Useful

B. Tai B. Tai 20102010

Page 34: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

• CDISC standardized

• HIPAA Compliant

• CTN Public data/documents include:– Data sets (SAS and ASCII)

– Defined file (aka data dictionary)

– Annotated Case Report Forms – Study protocol and reference to study publication of

primary outcomes

CTN Data Sharinghttp://www.ctndatashare.orgCTN Data Sharinghttp://www.ctndatashare.org

CTN 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0011, 0012, 0013, 0016, 0017, 0018, 0019, 0021, 0029

CTN 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0011, 0012, 0013, 0016, 0017, 0018, 0019, 0021, 0029

B. Tai B. Tai 20102010

Page 35: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

International Outreach: International Outreach: NIDA CTN INVEST FellowsNIDA CTN INVEST Fellows

• Create an international network of scientistsCreate an international network of scientists• CTN serves as the training platformCTN serves as the training platform• Senior non-U.S. scientists and health administratorsSenior non-U.S. scientists and health administrators

– 2007 (1), 2008 (3), 2009 (2) and 2010 (3)2007 (1), 2008 (3), 2009 (2) and 2010 (3)– Export CTN technology, identified future opportunities for Export CTN technology, identified future opportunities for

collaboration and fundingcollaboration and funding

http://international.drugabuse.gov/research/fellowships_investCTN.html http://international.drugabuse.gov/research/fellowships_investCTN.html

Page 36: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Council ReportCouncil Report2/3/20102/3/2010

Council ReportCouncil Report2/3/20102/3/2010

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

InfrastructureInfrastructure

ResearchResearch

Research utilizationResearch utilization

CTN next decadeCTN next decade

B. Tai B. Tai 20102010

Page 37: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

• Published – June 2009Published – June 2009

• Proposals – November 2009 Proposals – November 2009

• Review – February 2010Review – February 2010

• Council – May 2010Council – May 2010

• Award – September 2010Award – September 2010

CTN RFA 2009CTN RFA 2009

Stay Tuned…

B. Tai B. Tai 20102010

Page 38: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Future of the CTNFuture of the CTNMission/GoalsMission/Goals

• Bring drug abuse treatment into mainstream medical Bring drug abuse treatment into mainstream medical practicepractice– Engage providers from medical settingsEngage providers from medical settings

• Flexible research strategy/portfolioFlexible research strategy/portfolio– Seize new scientific opportunitiesSeize new scientific opportunities

– Address emerging public health concernsAddress emerging public health concerns

• Training platform for clinical workforceTraining platform for clinical workforce

• Facilitate research utilizationFacilitate research utilization

B. Tai B. Tai 20102010

Page 39: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

• Current

RRTC

CTP

CTP

CTP

CTP

CTP

Future of the CTNInfrastructures

• Future expansion

RRTC

Dental

HIV

ED

HMO

CTP

CTP

CTP

CTP

CTP

ED

HIV

CTP

PCP

B. Tai B. Tai 20102010

Optimal ratio of research $/infrastructure $ Optimal ratio of research $/infrastructure $

Page 40: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Future of the CTN Challenges and Opportunities

Future of the CTN Challenges and Opportunities

• Information Technology– Novel approaches to data collection, processing &

storage– EHR /EMR & real time EDC– Data standardization, access, reporting– Data privacy & confidentiality

• Approaches to accommodate physiologic and genetic information

• Information Technology– Novel approaches to data collection, processing &

storage– EHR /EMR & real time EDC– Data standardization, access, reporting– Data privacy & confidentiality

• Approaches to accommodate physiologic and genetic information

B. Tai B. Tai 20092009B. Tai B. Tai 20102010

Page 41: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Future of the CTN Challenges and Opportunities

Future of the CTN Challenges and Opportunities

• New statistical tools and techniques– adaptive design – simulation and modeling – large database mining

• Innovative trial/study designs– large, simpler and longer trials – pragmatic trials , comparative effectiveness trials– subgroup analysis

• Chronic Disease management model– treatment algorithm for continuing care

• New statistical tools and techniques– adaptive design – simulation and modeling – large database mining

• Innovative trial/study designs– large, simpler and longer trials – pragmatic trials , comparative effectiveness trials– subgroup analysis

• Chronic Disease management model– treatment algorithm for continuing care

B. Tai B. Tai 20092009B. Tai B. Tai 20102010

Page 42: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Future of the CTNAsk a different research question

• ““What” and “for whom” questionsWhat” and “for whom” questions

• ““How” questions How” questions – How to best practice based on efficacy and How to best practice based on efficacy and

side effects,side effects,

• Decision questionsDecision questions– How much time, training, and cost is entailed How much time, training, and cost is entailed

in the new treatment? Is the clinical benefit in the new treatment? Is the clinical benefit worth the cost? Is there a cost offset?worth the cost? Is there a cost offset?

Research questions that impact practice For a Chronic disease like addiction,

what is the first line treatment? Is there a next best treatment sequence at steps 2, 3, and 4? What sequence is best for whom?

What is the long-term outcome after steps 1, 2, 3, and 4?

B. Tai B. Tai 20102010

Page 43: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Future CTN PremisesFuture CTN PremisesFuture CTN PremisesFuture CTN Premises

• Addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs,

• Randomized, controlled clinical trials are the gold standard for generating evidence-based treatments,

• Engage the providers in the research process will improve the acceptability/adoption of research results.

• Address research questions that impact practice.

• Addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs,

• Randomized, controlled clinical trials are the gold standard for generating evidence-based treatments,

• Engage the providers in the research process will improve the acceptability/adoption of research results.

• Address research questions that impact practice.

B. Tai B. Tai 20092009B. Tai B. Tai 20102010

Page 44: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

www.nida.nih.gov/CTN/Index.htmwww.nida.nih.gov/CTN/Index.htmB. Tai B. Tai 20092009

Page 45: Betty Tai, Ph.D . February 3, 2010  Director Center for the Clinical Trials Network

Q&AQ&A

B. Tai B. Tai 20102010