1. 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. 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. 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. 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. 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. 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. 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. 8