HIDING THE BODIES. Wheezes Switching Endpoints Surrogate Outcomes 90%? NNT inappropriate LOCF Relative Risks Short term trials Miscoding Splitting Hazards.

Slides:

Advertisements

Similar presentations

1 Eloise E. Kaizar The Ohio State University Combining Information From Randomized and Observational Data: A Simulation Study June 5, 2008 Joel Greenhouse.

Advertisements

Depression Lawrence Pike.

Overview of Ferguson, et al. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline:

INDIVIDUAL VERSUS TECHNOLOGY Research, treatment and policy - ethical dilemmas Gabrielle Welle-Strand - Researcher, MD, Senior Adviser Pompidou Group –

Pharmacologic Treatments. 2 Cognitive Behavioural Therapy (CBT) Psychosocial Interventions.

CRITICAL READING Stephen Newell. December Reading a paper – R-E-A-D-ER  Relevant?  Educational? Does it add anything?  Applicable? Primary-care.

1 Recent Observational Studies of Antidepressants (ADs) and Suicidal Behavior Diane K. Wysowski, Ph.D. Office of Drug Safety FDA.

Antidepressants & the Politics of Health David Healy.

Is my thyroid making me fat? Justin Moore, MD, FACP Division Chief, Endocrinology and Metabolism Medical Director, Via Christi Weight Management.

HIV Clinical Trials Janice Price, M.Ed, RN HIV Clinical Research Program Coordinator Swedish Medical Center Seattle, WA USA.

St John’s wort for major depression (Review) Linde, Berner & Kriston (2008/9)

Journal Club Alcohol, Other Drugs, and Health: Current Evidence July–August 2008.

Evidence-based Treatment of Psychotic Depression Gregory W. Dalack, MD June 22, 2006.

Raymond J. Carroll Texas A&M University LOCF and MMRM: Thoughts on Comparisons.

Biological Therapies for depression:

 Sleep  Interest  Guilt  Energy  Concentration  Appetite  Psychomotor  Suicide.

Pharmacologic vs Non-pharmacologic Treatments for Depression Ferris State University Brittany Torok, Heather Torre, Erin VanderHorst, and Jamie Wilson.

1 Cost-effectiveness in Personality Disorder Dr. J.J.V. Busschbach Psychotherapeutic centre ‘De Viersprong’ –PO Box AA Halsteren

Clinical Trials. What is a clinical trial? Clinical trials are research studies involving people Used to find better ways to prevent, detect, and treat.

What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection.

Testing People Scientifically.  Clinical trials are research studies in which people help doctors and researchers find ways to improve health care. Each.

Depression in Adolescents and Young Adults: current best practice David Hartman Psychiatrist Child, Adolescent and Young Adult Service Institute of Mental.

Dr.F Eslamipour DDS.MS Orthodontist Associated professor Department of Oral Public Health Isfahan University of Medical Science.

Treatment for Adolescents With Depression Study (TADS)

Major Depressive Disorder Natalie Gomez Psychology Period 1.

Preventing Learned Helplessness In Depression Treatment Guideline Users Douglas E. Jorenby, Ph.D. Associate Professor 28 September 2005.

Evidence for the Effectiveness of Individual Placement and Support Model of Supported Employment Updated by Gary Bond.

THE ECLIPSE OF MEDICAL CARE. FILDES In the case of an attractive 7 year old in whom the disease had invaded the larynx, I inserted a tube which.

SIGN Non-Pharmaceutical Management of Depression in Adults Recommendations.

Antidepressants and Suicidality in Adults: Statistical Evaluation Mark Levenson, Ph.D.* and Chris Holland, M.S. Statistical Safety Reviewers Quantitative.

Depression and Parkinson Disease: An Old Drug Still Works (Better) Summary and Comment by Jonathan Silver, MD Published in Journal Watch Psychiatry February.

Module IV: Identification of Patients for Buprenorphine Treatment BUPRENORPHINE TREATMENT: A Training For Multidisciplinary Addiction Professionals.

DRUGPatientsSuicidal Acts Acts/ PEY % Suicides & Suicidal Acts Fluoxetine Comparator % 0.65% PROZAC – 1986 DATA.

Introductory Topics PSY Scientific Method.

Plans for Analysis of Patient Level Data for Pediatric Studies Psychopharmacologic Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective.

Antidepressants and Suicide Risk in Children and Adolescents: Weighing the Evidence Jill A. Morris, PA-S.

Cardiovascular Risk and NSAIDs Arthritis Advisory Committee Meeting November 29, 2006 Sharon Hertz, M.D. Deputy Director Division of Analgesia, Anesthesia,

FDA Hearing on Suicide and Antidepressants Presentation by Charles F. Reynolds, III, MD UPMC Professor of Geriatric Psychiatry University of Pittsburgh.

Findings from Taylor & Jason (2001) study Taylor, R.R. & Jason, L.A. (2001). Sexual abuse, physical abuse, chronic fatigue, and chronic fatigue syndrome:

Sertraline Use in Pediatric Population: A Risk Benefit Discussion Steven J. Romano, MD September 13, 2004 Steven J. Romano, MD September 13, 2004 Joint.

Evaluating the Medical Evidence A TOOLKIT FOR THE INTERPRETING THE EFFECTIVENESS OF INTERVENTIONS Niteesh Choudhy, M.D., Ph.D.

Effectiveness of Cognitive Behavioral Therapy and Selective Serotonin Reuptake Inhibitors in Adolescents with Depression Megan Boose, PA-S Evidence Based.

Module IV - Identification of Patients for Buprenorphine Treatment BUPRENORPHINE TREATMENT: A TRAINING FOR MULTIDISCIPLINARY ADDICTION PROFESSIONALS.

Applying CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage 2) in a Pre- Hospital Wilderness Context Paul B. Jones PGY1.

J Mann A Clinical Perspective on Safety and Efficacy of SSRIs in Depressed Children and Adolescents J. John Mann, MD President, American Foundation for.

UK Community Advisory Board (UK- CAB) HIV treatment advocates network Introduction to Trials and Research Robert James, Birkbeck College, University of.

Date of download: 6/9/2016 From: Escitalopram for the Prevention of Peginterferon-α2a–Associated Depression in Hepatitis C Virus– Infected Patients Without.

Date of download: 7/7/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Comparative Mortality Risk in Adult Patients With.

What FDA Failed to Disclose 1991, 2006 Vera Hassner Sharav Alliance for Human Research Protection NJPIRG Law & Policy Center MAY 2006.

The Downside of Publication

Working with Adolescents: Additional Considerations

Smoking Cessation, Suicide and Varenicline: A Systematic Review

Department of Behavioral Sciences

Characteristics of the Folic Acid and Placebo Groups at the Start of the Study J. Durga et al. Arch Intern Med. 2005;165:

Efficacy of Paroxetine (Paxil) in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial Case Study presented by: carlo carandang,

Pilot Studies: What we need to know

Sertraline In this section we’ll discuss the most relevant aspects of sertraline.

Issues in Hypothesis Testing in the Context of Extrapolation

Antidepressants for Bipolar Depression: Answering Clinical Questions

Copyright Notice This presentation is copyrighted by the Psychopharmacology Institute. Subscribers can download it and use it for professional use. The.

Jacques Irani European Urology Supplements

Subgroup analysis of the 17 trials comparing haloperidol and placebo in schizophrenia (outcome: response rate). Subgroup analysis of the 17 trials comparing.

Funnel plot of the 17 trials comparing haloperidol and placebo in schizophrenia (outcome: response rate). Funnel plot of the 17 trials comparing haloperidol.

Jun Ishigooka_the 3rd Kitasato-Harvard Symposium

Obsessive-Compulsive Disorder: Pharmacotherapy

The Research Question Background: Question:

The American College of Cardiology Presented by Dr. Timothy Henry

Contour-enhanced funnel plot of the 17 trials comparing haloperidol and placebo for clinical improvement in schizophrenia. Contour-enhanced funnel plot.

Criteri di scelta dell’antidepressivo

Presentation transcript:

HIDING THE BODIES

Wheezes Switching Endpoints Surrogate Outcomes 90%? NNT inappropriate LOCF Relative Risks Short term trials Miscoding Splitting Hazards Co-administration Choice of Comparator & Dose Ecological fallacy Publication Strategies

screening randomization drugpbo Run-in/wash out Stop treatment Start treatment FLUOXETINE – PAROXETINE - SERTRALINE ADULT TRIALS Occurrence of suicidal acts follow-up Healy BMJ 2006

screening randomization drugpbo Run-in/wash out follow - up Stop treatment Start treatment FLUOXETINE – PAROXETINE - SERTRALINE ADULT TRIALS Reporting of suicidal acts Vioxx Avandia

Paroxetine in treatment of intermittent brief depression [ Montgomery et al 1993] PARPLCn = 18 overall response [%] depressive episodes [n] mean MADRS score mean duration [days] suicide attempts / year

GSK Paroxetine Suicidal Acts 11 v 0 Placebo Suicidal Acts

GSK Paroxetine 43 v 35 Placebo RR – 0.74

P=.04 Drug A DOUBT IS OUR PRODUCT

P=.09 P=.04 Drug ADrug B DOUBT IS OUR PRODUCT

RR=1.9 (0.2, 16)

SAFE TRAVEL: SPACE SHUTTLE Mixed Messages

THE SPIN NO DATA CAN OVERCOME

April 15, 1991 Memo to Leigh Thompson Upcoming TV appearance Section I. MESSAGE GOALS, the three points.. are: 2. Its in the disease, not the drug. Section III If pressed, or as a postscript to the above, then make the point that absolutely no evidence indicates PROZAC as a cause of such behavior (violence and suicide)., and Prozac defense… There is simply no medical or scientific merit to the argument. Exhibit 123

screening randomization drugpbo Run-in/wash out Stop treatment Start treatment RANDOMIZED CONTROLLED TRIALS Bias 1: Suicidal Acts follow-up

screening randomization drugpbo Run-in/wash out Stop treatment Start treatment RANDOMIZED CONTROLLED TRIALS Bias 2: Suicidal Acts follow-up

EVIDENCE BASED MEDICINE

Thalidomide Randomized Controlled Trials

Alle Ding' sind Gift, und nichts ohn' Gift; allein die Dosis macht, daß ein Ding kein Gift ist.

Objective v Subjective Certainty v Uncertainty Mechanical v Thoughtful Autopilot v Professional Risky Doctor v Risky Drug

RCTS Are not a gold standard Do not demonstrate Cause and Effect Should never replace good evidence Significance testing should be about credibility

LORD OF THE RINGS

The American Psychiatric Association believes that antidepressants save lives.

The American Psychiatric Association believes that psychiatrists save lives.