1 Other Issues for Statisticians in Medical Devices Gregory Campbell, Ph.D. Director, Division of Biostatistics Center for Devices and Radiological Health,

Slides:

Advertisements

Similar presentations

Labeling claims for patient- reported outcomes (A regulatory perspective) FDA/Industry Workshop Washington, DC September 16, 2005 Lisa A. Kammerman, Ph.D.

Advertisements

Drugs vs. Devices Jeng Mah & Gosford A Sawyerr Sept 16, 2005.

Non-randomized studies: Studies with historical controls and the use of Objective Performance Criteria (OPCs) Jeff Cerkvenik Statistics Manager Medtronic,

Delete these guides from slide master before printing or giving to the client 1 Bayesian Trial Design – Case studies Panelists Andrew Mugglin, Medtronic.

Parallel Session 9 Contemporary Challenges in Statistical Evaluation of Diagnostic Products Chairs:Gene Pennello (CDRH) Lakshmi Vishnuvajjala (CDRH) Stuart.

Postmarket Surveillance of Medical Device Adverse Events Hesha Jani Duggirala, PhD Epidemiology Branch Division of Postmarket Surveillance Office of Surveillance.

FDA/Industry Statistics Workshop 2005 Parallel Session 6: Vaccine Trials 10:10 am – 11:30 am, Sept. 16, 2005.

Discussion: Biostatistics in Public Policy

MEDICAL DEVICES: GOING HOME Food and Drug Administration Center for Devices and Radiological Health June 2004.

EPAA Conference 5 November 2007 Georgette LALIS Enterprise and Industry DG European Commission The international dimension of regulatory acceptance.

BME-IDEA Workshop, September 28, 2005

Clinical Research Importance of resume. Resume The first impression And maybe the last too….

Strengthening the Medical Device Clinical Trial Enterprise

Pharmacogenomics in Japan Hiroshi Gushima Scientific Advisor BioFrontier Partners, Inc. and Yamanouchi Pharmaceutical Co., Ltd. October 3, 2002 The 3rd.

1 EDRN: Some Statistical Considerations from a Regulatory Point of View Gregory Campbell, Ph.D. Director, Division of Biostatistics CDRH/FDA.

EDC PHARMA SERVICES Capacity. Expertise. Solutions. Technology.

FDA’s Critical Path to New Medical Product Development Opportunities from the Center for Devices and Radiological Health Larry Kessler, Sc.D., Director.

The ICH E5 Question and Answer Document Status and Content Robert T. O’Neill, Ph.D. Director, Office of Biostatistics, CDER, FDA Presented at the 4th Kitasato-Harvard.

WUSS 2009 CDISC for the Medical Device and Diagnostic Industry: An Update Carey Smoak Team Leader CDISC Device SDTM Sub-team.

GLOBAL REGULATORY STRATEGY CONSIDERATIONS SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES SEPTEMBER 14-17, 2008 BOSTON, MA.

FDA Resources and Meetings FDA/EMA Orphan Designation and Grant Workshop Silver Spring, Maryland FDA Campus (White Oak) October 12, 2012 Bill Sutton Deputy.

Office of Combination Products: Current Initiatives

1 FDA Regulation of Cell Therapy Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies Fourth Annual Translational Stem.

Understanding the Pre-IDE Program: FDA Perspective

Drug Submissions: Review Process Agnes V. Klein, MD Biologics and Genetic Therapies Directorate February, 2003 www/hc-sc.gc.ca/hpb-dgps/therapeut.

1 RCRIM Vocab-BRIDG Session Wednesday, Session Q2 19 September 2007.

UNCLASSIFIED10/12/ :41 AM Slide 1 Division of Regulated Activities and Compliance.

1 CONSENSUS STANDARDS OIVD WORKSHOP April 22-23, 2003 Rockville MD Ginette Y. Michaud, M.D. OIVD.

Humanitarian Use Devices September 23, 2011 Theodore Stevens, MS, RAC Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and.

The SNM Centralized IND & Clinical Trials Network Enabling Implementation Investigational & Approved PET Imaging in Multicenter Clinical Trials George.

1 CDRH: Minimizing Risk of TSE Agents in Medical Devices CDR Martha O’Lone, RN, BSN CDRH TSE Working Group Chair Infection Control Devices Branch DAGID.

Current Plan for Critical Path Initiative Janet Woodcock, M.D. Acting Deputy Commissioner For Operations November 5, 2004.

Regulatory Decision Making D. Kathleen Wright, Reviewer Division of Microbiology Office of In Vitro Diagnostic Device Evaluation & Safety ( OIVD ) Food.

© Guidant 2005 Surrogate Endpoints and Non-randomized Trials Roseann White Humble Biostatistician.

FDA Standards Development and Implementation Randy Levin, M.D. Director, Office of Information Management Center for Drug Evaluation and Research Food.

1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.

Research in the Office of Cellular, Tissue and Gene Therapies: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation.

Methodological Issues in Implantable Medical Device(IMDs) Studies Abdallah ABOUIHIA Senior Statistician, Medtronic.

75 years of excellence Combination Products NEMA’s Comments for the Office of Combination Products Public Hearing Terry Sweeney, Philips Medical Systems.

Establishment of Medical Device GMP Requirements Hsiau-Wen Huang, Ph. D. Senior Researcher Bureau of Pharmaceutical Affairs Department of Health.

Auditing ISO Nancy Pasquan November Introductions I am….. You are….. And we are here to discuss: Auditing ISO Quality Systems for Medical.

ISO/HL Specification: Individual Case Safety Report (ICSR) Release 2 Lise Stevens Data Standards Project Manager FDA CBER/ADRM Bioinformatics Support.

November 9, 2015 February 20, 2017 Using real world evidence – industry perspective Pma indication expansion Melissa hasenbank, phd Sr. Clinical Research.

Rachel Neubrander, PhD Division of Cardiovascular Devices

U.S. FDA Center for Devices and Radiological Health Update

FDA Division of Cardiovascular Devices

Regulatory Considerations for Coronary Drug Coated Balloons (DCBs)

Jeff Shuren, MD, JD Center for Devices and Radiological Health U. S

Director, Asia Pacific Japan and U.S. Clinical Operations

FDA Perspective on Cardiovascular Device Development

DIA Clinical Safety and Pharmacovigilance Community

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

Statistical Approaches to Support Device Innovation- FDA View

The FDA Early Feasibility Study Pilot and the Innovation Pathway

Deputy Director, Division of Biostatistics No Conflict of Interest

Regulatory Synergies in Device Innovation

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

Lessons Learned: Past Present and Future Japan-USA Regulatory Interactions Erica Takai, PhD US Food and Drug Administration

Lessons Learned Through HBD: The Regulator’s View - US FDA

9/17/2018 Meeting local HTA requirements Challenges for the Pharma HTA Statistician Marie-Ange PAGET Project Statistician – Lilly France EFSPI meeting.

FDA/INDUSTRY STATISTICS WORKSHOP: Washington, D. C. Sept

Freundschaft Konferenz

Progress Report on the Patient Reported Outcomes Harmonization Team

FDA Resources and Meetings

Challenges to the Therapeutic Pipeline for Irritable Bowel Syndrome: End Points and Regulatory Hurdles Michael Camilleri, Lin Chang Gastroenterology

Larry Kessler, Sc.D. Director

Patient Involvement in the Development and Safe Use of

Clinical Research Association TURKEY

Dr Manisha Shridhar Regional Advisor WHO-SEARO

Safety Analytics Workshop – Computational Science Symposium 2019

Presentation transcript:

1 Other Issues for Statisticians in Medical Devices Gregory Campbell, Ph.D. Director, Division of Biostatistics Center for Devices and Radiological Health, FDA FDA-Industry Workshop Washington DC September 16, 2005

2 Sessions with Strong Device Relevance Bayesian Trial Design Thurs. AM Pharmacogenomics Thurs. PM PostMarket Adverse Events Fri. AM Non-inferiority Studies Fri. AM Statist. Eval. of Diagnostic Products Fri PM Statist. Methods for Nonrandomized and Subverted Trials Fri. PM

3 Combination Products Combination drug-therapeutic device –Drug-eluting stents –Drug pumps Combination drug-diagnostic device –Devices that diagnose and then deliver therapy Separate drug, separate diagnostic device –Pharmacogenomics Co-development document

4 Communication with CDRH How to request a statistical meeting Who to contact? When? Early with pre-IDE and pre-PMA meetings Agreement and Determination Meetings

5 Least Burdensome Provision and Levels of Evidence At first sight one might think that an historically controlled study is less burdensome than a randomized clinical trial. However, if the historical control cannot be demonstrated to be comparable with the data from the current study, then the study may be not controlled (so no comparison is possible) and another study may need to be launched.

6 National and International PhARMA and DIA versus Advamed and MDMA International Conference on Harmonization (ICH) versus Global Harmonization Task Force (GHTF) Organizations with an international presence (DIA vs. Advamed) as well as standards organizations: ISO, CLSI (NCCLS), ASTM, AAMI Few statisticians who are in government regulatory positions outside US (Japan PMDA, UK, Germany) all of whom serve both drugs and devices

7 Other Statistical Venues Joint Statistical Meetings –9 device sessions in Minneapolis orchestrated by a committee from industry and CDRH and an organizational meeting Society for Clinical Trials and ENAR Standards organizations Other professional meetings where statistical topics arise Help to plan future meetings

8