BACKGROUND & SIGNIFICANCE SUMMARY & FUTURE DIRECTIONS

Slides:

Advertisements

Similar presentations

1 FDA Industry Workshop Statistics in the FDA & Industry The Future David L DeMets, PhD Department of Biostatistics & Medical Informatics University of.

Advertisements

Transforming Correlative Science to Predictive Personalized Medicine Richard Simon, D.Sc. National Cancer Institute

Update on a recently launched European R&D endeavour: The Innovative Medicines Initiative (IMI) FERS meeting Brussels, 7 th April 2008.

Karran A. Phillips, MD, MSc NIDA Intramural Research Program AMERSA Annual Meeting November 8, 2014.

Evidence Based Surgical Nursing – Reviewing the Evidence Carl Thompson Dept of Health Sciences, University of York.

Addiction UNIT 4: PSYA4 Content The Psychology of Addictive Behaviour Models of Addictive Behaviour  Biological, cognitive and.

Research & Innovation Horizon societal challenge 1 Open Info Day Funding Opportunities for SMEs Horizon 2020 "Health, demographic change and wellbeing"

Luděk Bláha, PřF MU, RECETOX BIOMARKERS AND TOXICITY MECHANISMS 13 – BIOMARKERS Summary and final notes.

David A H Whiteman MD FAAP FACMG Global Clinical Sciences Leader Shire Pharmaceuticals.

Substance Use and Abuse Smoking. Smoking Tobacco: Who Smokes? Varies with age Gender differences Educational differences.

Prevention strategies and treatments HANEWINKEL AND WIBORG DAVIS ET. AL Claire Evenson, Niveda Ganesh, Nadia McCloskey, and Heather Purchas.

Can undergoing an internet based ACT intervention change the impact of predictors thought to lead to Substance Use? Leonidou. G., Savvides. S., N. & Karekla.

Nicotine Holley Williamson and Rachel Martinez. Addiction Chewed, Smoked, or Inhaled Absorbed within 7 Seconds of inhalation Nicotine molecule shaped.

Effect of Depression on Smoking Cessation Outcomes Sonne SC 1, Nunes EV 2, Jiang H 2, Gan W 2, Tyson C 1, Reid MS 3 1 Medical University of South Carolina,

Motivational Interviewing (MI) is effective and efficient for fostering health behavior change, and the elicitation of “change talk” (CT: i.e., any expression.

Cancer Centers In Clinical Trials Sandrine Marreaud Head of Medical Department.

A systematic review of the impact of work environment factors on changes in smoking Karen Albertsen Vilhelm Borg Brian Oldenburg National Institute of.

Using Predictive Classifiers in the Design of Phase III Clinical Trials Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute.

SMOKING in ADOLESCENTS with PSYCHIATRIC or ADDICTIVE DISORDERS.

1 Impact of Depression History on Tobacco Withdrawal and Relapse Among Female Smokers David W. Wetter, Ph.D. Department of Behavioral Science Funded by.

“Comparing Two web-based Smoking Cessation Programs: Randomized- Controlled Trial” By: McKay et. Al.

First Annual Meeting. Pioneering the Use of Genomic Biomarkers in Assessing Risk to Environmental and Human Health An established and effective collaboration.

Ten Years of Pharmacotherapy Trials in the CTN: An Overview.

NIAMS Extramural Scientific Planning Retreat 2013 April 4, 2013 Session 1: Strategies for Successful Rare Disease Clinical Trials.

Surrogate Endpoints as Measures of Efficacy: Complexities & Limitations FDA Advisory Committee November 18, 2002 Michael D. Hughes, Ph.D. Professor of.

1 Access to and use of aids to smoking cessation in the UK Robert West University College London Austin, Texas February 2007.

Resource Allocation in Translational Neuroscience Tom Insel, M.D. Director National Institute of Mental Health National Institutes of Health March 5, 2009.

1 Cancer Research UK smoking cessation programme at UCL: Robert West University College London London October 2007.

Internal Barriers to Seeking Smoking Cessation Treatment John Hughes, M.D.

Clare Meernik, MPH 1 ; Anna McCullough, MSW, MSPH, CTTS 1 ; Leah Ranney, PhD 1 ; Barbara Walsh 2 ; Adam O. Goldstein, MD, MPH 1 Predictors of Quit for.

Fax to Assist On-line Training for Certification Sponsored by Maryland Department of Health and Mental Hygiene and University of Maryland Baltimore County.

1 Addiction to tobacco Robert West University College London November

1 Effects on smoking cessation of a national strategy to maximise NRT usage: the UK experience Robert West University College London WCTOH July 2006 Washington.

1 Should behavioural support for smoking cessation address wider psychological problems? University College London October 2013 Robert West.

ALCOHOL DRUGS TOBACCO. Different types of addictions - Alcohol - Tobacco - Drugs.

Quick overview of quit smoking counseling for people with mental health or substance use disorders Associate Professor of.

Alcohol abuse and dependence. Experimental and clinical evidence

Assistant professor Family Medicine - Suez Canal University

Modelling Madness Susan Totterdell.

Smoking and smoking cessation in the real world

Robert West University College London WCTOH Washington 2006

Evidence-based Medicine

Copyright © 2011 American Medical Association. All rights reserved.

Robert West University College London London March 2008

How to read a paper D. Singh-Ranger.

Reasonable Assurance of Safety and Effectiveness: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division.

Behavioural and pharmacological approaches to treating smokers

Babson, et al., in progress Isabella Romero

Medical Device Regulatory Essentials: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

The Burden of Tobacco Use

EMA Outcome Measures in a Clinical Trial

Progress Report U Aims 1 & 2: To test L-NAP and other compounds for therapeutic potential in preventing alcohol-induced damage to the cerebellum.

Predicting treatment outcome: An examination of the mechanism of action of two pre-quit smoking cessation pharmacotherapies Associate Professor Stuart.

Diagnostic Assessment: Clinical Applications

Developing a Health Maintenance Schedule

Alcohol, Other Drugs, and Health: Current Evidence May-June, 2018

Regulatory perspective

Diagnostic Testing: Clinical Applications

Comments on design and sequence of biomarker studies

EARLY Combination Therapy in PAH: What Every Cardiologist Needs to Know.

بسم الله الرّحمن الرّحيم. Dr Sima Sadrai TUMS

2009 Papers of Interest David Tinkelman.

Why study Brain tumour Biology???

SCIMITAR+: a definitive RCT of a smoking cessation intervention for people with severe mental ill health Emily Peckham.

Jennifer M. Croswell, Barnett S. Kramer Journal of Hepatology

Translation Pathway for Coronary Stent Development- Clinical Endpoints

Risky or rational? Alcohol increases the subjective value of

Biomarkers as Endpoints

Tobacco Cessation for Primary Care Providers

Journal Editor Perspectives

Presentation transcript:

BACKGROUND & SIGNIFICANCE SUMMARY & FUTURE DIRECTIONS The NPU Task: Evaluating a Surrogate Endpoint for Stress Mechanisms in Research on Smoking Cessation Interventions Katherine P. Magruder, Jesse T. Kaye, Megan N. Fleming, Austin D. Kayser, Susan E. Schneck, & John J. Curtin Addiction Research Center, Psychology Department, University of Wisconsin-Madison BACKGROUND & SIGNIFICANCE Overall Stressor Reactivity Fails to Significantly Predict Probability of Lapsing Relative Unpredictable Stressor Reactivity Fails to Significantly Predict Probability of Lapsing Surrogate endpoints are robust, early predictors of clinically relevant outcomes. Surrogate endpoints are advantageous for three reasons: 1. Available much earlier than ultimate clinical outcomes1,2 2. Establish an intervention’s mechanism of action3,4 3. More power to test impact of intervention on this mechanism5,6 Stressor reactivity is a target for many interventions in addiction but we do not have well-validated surrogate endpoints for stress-induced relapse mechanisms. Basic science combines with preliminary clinical research to suggest that overall stressor reactivity and relative unpredictable stressor reactivity as measured by startle potentiation in the NPU task may be attractive surrogate endpoints for this purpose.7,8 OBJECTIVES The goal of this study was to evaluate a key requirement for two potential surrogate endpoints – their ability to predict clinical outcomes. We tested if overall stressor reactivity and relative unpredictable stressor reactivity for recently abstinent daily cigarette smokers (N = 128) predicts probability of lapsing during two-week cessation attempt. METHODS * SUMMARY & FUTURE DIRECTIONS Our pre-registered hypotheses were not supported. Specifically, overall stressor reactivity and selective unpredictable stressor reactivity did not significantly predict probability of lapsing during two-week cessation attempt. These results raise some concern about overall and selective unpredictable stressor reactivity as surrogate endpoints in research on smoking cessation interventions. However, these null results must be tempered by important study limitations of low power: - Relapse broadly vs. stress-induced relapse - Rates of continuous abstinence NPU STRESSOR TASK REFERNCES 1. McKee, S. A. (2009). Developing human laboratory models of smoking lapse behavior for medication screening for medication screening. Addiction Biology, 14(1), 99-107. 2. Prentice, R. L. (1989). Surrogate endpoints in clinical trials: Definition and operational criteria. Statistics in Medicine, 8, 431-440. 3. Insel, T. R. (2012). Next-generation treatments for mental disorders. Science Translational Medicine, 4(155), 155ps19. 4. Lerman, C., LeSage, M. G., Perkins, K. A., O’Malley, S. S., Siegel, S. J., Benowitz, N. L., & Corrigall, W. A. (2007). Translational research in medication development for nicotine dependence. Nature Reviews Drug Discovery, 6(9), 746-762. 5. Lesko, L. J., & Atkinson, A. J. (2001). Use of biomarkers and surrogate endpoints in drug development and regulatory decision-making: Criteria, validation, and strategies. Annual Review of Pharmacology and Toxicology, 41, 347-366. 6. Fleming, T. R., & Powers, J. H. (2012). Biomarkers and surrogate endpoints in clinical trials. Statistics in Medicine, 31(25), 2973-2984. 7. Walker, D. L., Toufexis, D. J., & Davis, M. (2003). Role of the bed nucleus of the stria terminalis versus the amygdala in fear, stress, and anxiety. European Journal of Pharmacology, 463, 199-216. 8. Davis, M., Walker, D. L., Miles, L., & Grillon, C. (2010). Phasic versus sustained fear in rats and humans: Role of the extended amygdala in fear versus anxiety. Neuropsychopharmacology Reviews, 35, 105-135.