1 Clinical Studies Section of Labeling Joseph Porres, M.D., Ph.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA.

Slides:

Advertisements

Similar presentations

Interpreting of Patient-Reported Outcomes

Advertisements

A Flexible Two Stage Design in Active Control Non-inferiority Trials Gang Chen, Yong-Cheng Wang, and George Chi † Division of Biometrics I, CDER, FDA Qing.

CBER Isolagen Therapy (IT) BLA FDA Clinical Review Agnes Lim, MD Yao-Yao Zhu, MD, PhD DCEPT/OCTGT/CBER, FDA October 9, 2009 Advisory Committee Meeting.

Martha J. Morrell MD NeuroPace, Inc.

1 Efficacy of Testosterone Transdermal System (TTS) for Treatment of HSDD in Surgically Menopausal Women on Concomitant Estrogen Daniel Davis, MD, MPH.

Effectiveness Evaluation for Therapeutic Drugs for Non-Food Animals

Smoking Cessation in Smokers Motivated to Quit Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Robert Anthenelli.

Badrul A. Chowdhury, MD, PhD

CR-1 Concluding Remarks and Risk/Benefit Summary Mace L. Rothenberg, MD Professor of Medicine Vanderbilt Ingram Cancer Center.

Luveris ® New Drug Application ( ) Kate Meaker, M.S. Statistical Reviewer Division of Biometrics II Kate Meaker, M.S. Statistical Reviewer Division.

Hormone Refractory Prostate Cancer A Regulatory Perspective of End Points to Measure Safety and Efficacy of Drugs Hormone Refractory Prostate Cancer Bhupinder.

SUMMIT ON CANCER CLINICAL TRIALS - V Dilimmas and Complexities of Compassionate Use.

1 Kepivance™ (Palifermin) Basis for Approval and Pediatric Studies Kepivance™ (Amgen) Approved 12/15/04 Joseph E. Gootenberg, M.D. Office of Oncology Drug.

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

NDA ZD1839 for Treatment of NSCLC FDA Review Division of Oncology Drug Products.

Macugen (pegaptanib sodium injection) Dermatology and Ophthalmology Advisory Committee Meeting Rockville, Maryland August 27, 2004 Dermatology and Ophthalmology.

1 Statistical Review Dr. Shan Sun-Mitchell. 2 ENT Primary endpoint: Time to treatment failure by day 50 Placebo BDP Patients randomized Number.

CAST: Cardiac Arrhythmia Suppression Trial Purpose To determine whether therapy with class Ic antiarrhythmics to suppress asymptomatic or mildly symptomatic.

ACAMPROSATE Efficacy Results from Three Pivotal Efficacy Trials Karl F. Mann, M.D. Professor and Chairman Director, Department of Addictive Behavior and.

1 Proton-Pump Inhibitor (PPI) Template for Pediatric Written Requests Pediatric Advisory Subcommittee of the Anti- Infective Drug Advisory Committee Hugo.

AIRE: Acute Infarction Ramipril Efficacy study Purpose To determine whether the ACE inhibitor ramipril reduces mortality in patients with evidence of heart.

1 Statistics in Drug Development Mark Rothmann, Ph. D.* Division of Biometrics I Food and Drug Administration * The views expressed here are those of the.

NDA SE-011 Docetaxel FDA Review. FDA Review Team Biostatistics –Clara Chu, PhD. –Gang Chen, PhD. Biopharmaceutics –Safaa Ibrahim PhD –Atiq Rahman,

August 20, 2003FDA Antiviral Drugs Advisory Committee Meeting 1 Statistical Considerations for Topical Microbicide Phase 2 and 3 Trial Designs: A Regulatory.

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

FDA’s Osteoporosis Guidance Center for Drug Evaluation and Research Division of Metabolic and Endocrine Drugs Eric Colman, MD September 25, 2002.

CLINICAL EFFICACY TESTING for NASAL DRUGS Mary M. Fanning, M.D., Ph.D. Associate Director for Medical Affairs Office of Generic Drugs, FDA June 4, 1999.

1 Study Design Issues and Considerations in HUS Trials Yan Wang, Ph.D. Statistical Reviewer Division of Biometrics IV OB/OTS/CDER/FDA April 12, 2007.

1 Mohamed Alosh, Ph.D. Kathleen Fritsch, Ph.D. Shiowjen Lee, Ph.D. DBIII, OB, CDER, FDA Efficacy Evaluation in Acne Clinical Trials.

1 Markham C. Luke, M.D., Ph.D. Dermatology Clinical Team Leader DDDDP, ODE V, CDER, FDA Combination Topical Products for the Treatment of Acne Vulgaris.

Dermatologic and Ophthalmic Drugs Advisory Committee July 12, Clinical Safety Oral Tazarotene NDA Denise Cook, M.D. Medical Officer Division.

1 FDA Perspective on Global Evaluation of Facial Acne Brenda Carr, M.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA.

Thrice-Weekly Glatiramer Acetate for Relapsing Forms of Multiple Sclerosis: Findings from the GALA Study Fred D. Lublin, MD Saunders Family Professor of.

1 Pulminiq™ Cyclosporine Inhalation Solution Pulmonary Drug Advisory Committee Meeting June 6, 2005 Statistical Evaluation Statistical Evaluation Jyoti.

What about VIOXX?. Adenomatous Polyp Prevention on Vioxx (APPROVe) Vioxx (rofecoxib) versus Placebo Basic Clinical Trial Objective: Assess whether Vioxx.

Agency Review of sNDA SE-006 DOXIL for Ovarian Cancer Division of Oncology Drug Products Office of Drug Evaluation 1 Center for Drug Evaluation.

Clinical Trials - PHASE II. Introduction  Important part of drug discovery process  Why important??  Therapeutic exploratory trial  First time in.

Zometa for Prostate Cancer Bone Metastases Protocol 039 Amna Ibrahim, M.D. Oncology Drug Products FDA.

Safety, Efficacy and Duration of Effect of RT002, a Botulinum Toxin Type A for Injection, to Treat Glabellar Lines: The Phase 2 BELMONT Study Authors:

Erlotinib plus Gemcitabine Compared with Gemcitabine Alone in Patients with Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute.

Rene Descartes: “I think; therefore I am.”. 3.3: Data Ethics Statistics Chap 3: Designing Experiments.

Clinical Trial : Analysis & Interpretation of Results Fixed dose combination therapy of antioxidants in treatment of idiopathic oligoasthenoteratozoospermia:

Date of download: 6/21/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Adapalene Gel, 0.1%, as Maintenance Therapy for Acne.

J Clin Oncol 30: R2 윤경한 / Prof. 김시영 Huan Jin, Dongsheng Tu, Naiqing Zhao, Lois E. Shepherd, and Paul E. Goss.

Date of download: 9/19/2016 Copyright © The American College of Cardiology. All rights reserved. From: Clinical Efficacy of Ivabradine in Patients With.

An Alternative to Data Imputation in Analgesic Clinical Trials David Petullo, Thomas Permutt, Feng Li Division of Biometrics II, Office of Biostatistics.

Patient Focused Drug Development An FDA Perspective

SUMMIT ON CANCER CLINICAL TRIALS - V

Copyright © 2015 by the American Osteopathic Association.

Long term effectiveness of perampanel: the Leeds experience Jo Geldard, Melissa Maguire, Elizabeth Wright, Peter Goulding Leeds General Infirmary, Leeds.

A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment Diane.

Copyright © 2002 American Medical Association. All rights reserved.

Martha Carvour, MD, PhD March 2, 2017

CVRx Baroreflex Activation Therapy:

Volume 119, Issue 10, Pages (October 2012)

Strength of Evidence; Empirically Supported Treatments

Barrios C et al. SABCS 2009;Abstract 46.

PCP Perspectives Clinical Considerations in Hyperkalemia

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to.

Two randomized, double-blind, placebo-controlled studies of fluticasone propionate lotion 0.05% for the treatment of atopic dermatitis in subjects from.

A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment Diane.

A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies Linda.

Olumacostat glasaretil, a novel topical sebum inhibitor, in the treatment of acne vulgaris: A phase IIa, multicenter, randomized, vehicle-controlled study

Effect of aprotinin on clinical outcomes in coronary artery bypass graft surgery: A systematic review and meta-analysis of randomized clinical trials

The Acne Landscape Is Evolving

Introduction to Research Methods in Psychology

A phase II, multicenter, open-label, 3-cohort trial evaluating the efficacy and safety of vismodegib in operable basal cell carcinoma Howard Sofen, MD,

Assessed for eligibility N = 15593

Two randomized, double-blind, controlled trials of 2219 subjects to compare the combination clindamycin/tretinoin hydrogel with each agent alone and vehicle.

Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: A pooled analysis of the Phase 3 VOYAGE 1 and VOYAGE.

Presentation transcript:

1 Clinical Studies Section of Labeling Joseph Porres, M.D., Ph.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA

2 Clinical Studies Section of Labeling Efficacy Endpoints: The following endpoints have been used to evaluate efficacy in Phase 3 trials for acne: §Acne lesions: l total lesion count l inflammatory lesion count l non-inflammatory lesion count §Investigator Global Evaluation (IGE): assessment of the condition of acne at the predefined evaluation point

3 Clinical Studies Section of Labeling § pivotal trials § duration of the studies § number of patients who received drug treatment and the number who received placebo (or vehicle) § mean age at enrollment. § statistically significant difference § types of patients included, or excluded: severity, gender, pregnancy, age

4 Clinical Studies Section of Labeling “Drug product P was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received P and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six cycles each study demonstrated a statistically significant difference between P and placebo for mean change from baseline in lesion counts (see Table T and Figure F). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied.”

5 Clinical Studies Section of Labeling

6

7

8 “Drug Product users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.” Studies where baseline counts differ for each study.

9 Clinical Studies Section of Labeling

10 Clinical Studies Section of Labeling In summary: §Presenting information as text, tables, and figures offers prescribers a comprehensive summary of the efficacy data observed in Phase 3 trials. §The three formats complement each other since each one is helpful in conveying a particular aspect of the data.