Other Issues for Statisticians in Medical Devices

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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
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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

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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

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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

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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.

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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

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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

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