Clinical Trials 2011

Clinical Trials 2011 - ClicktoeditMastersubtitlestyle...

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 3/5/11 Click to edit Master subtitle style Michael Jamieson MS, DRSc(c) Regulatory Science Program USC School of Pharmacy February 4, 2011
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 3/5/11 A Dummies Guide to Clinical  GCP Good Clinical Practices IDE    Investigational Device Exemption IND Investigational New Drug IRB Institutional Review Board AE Adverse Event MDR Medical Device Reporting
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 3/5/11 Why Do A Clinical Trial? Support Regulatory Submissions.              (510K,  PMA) Establish Claims for Marketing. Gain Insight Into Product Performance.     (Safety  and Efficacy Profile)
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 3/5/11 “Safety” Assessed by: q  Adverse events associated with       the device; and or q  Specific outcome measures for     negative effects or surrogate        markers for negative effects.
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 3/5/11 Click to edit Master subtitle style Effectiveness There is reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence , that in a significant portion of the target population , the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results .” 21 CFR 860.7
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 3/5/11 Common Elements in Clinical  Ø Alternatives to randomized controlled trials § Non-randomized controls § Foreign data § Historical, literature controls  § Longitudinal trials Ø Masking/blinding Ø Surrogate endpoints Ø Data safety management boards
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 3/5/11 Typical Features of Device Trials Multiple outcome measures. Need for careful statistical predictions and  follow-up. Blinding challenges. Often-inexperienced teams.
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Basic Clinical Trial Design Study Population Treatment No Treatment (e.g. placebo) Yes No Yes No STUDY PERIOD OUTCOME of INTEREST RANDOMIZATIO N
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 3/5/11 In Vitro Tests  In Vivo  Tests: Animals Clinical trials: Humans
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 3/5/11 Mfr. Applies to FDA for Permission to Conduct Clinical Tests Judge d to be safe & effecti ve? Product Approved Manufacturer Completes Trial & Submits Results to FDA as Application to Market Product. “The Drawing Board” ID E? YE S YE S N O N O 510K PMA
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 3/5/11 What Have We Done So Far??? Design History of Device. Product Qualification Testing. Biocompatibility Testing (if implantable or in  contact) Risk Analysis. Pre-Clinical Animal Studies. 
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 3/5/11 1212 Preclinical Research Clinical Studies PMA review Feasibility Pivotal Animal Testing Industry time FDA time IDE submission Approval Postmarket Surveillance Marketing Institutional  Review Boards Device Development Path for US FDA Design History File Good Manufacturing Practices Risk Analysis Device development PMA submission revisions
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 3/5/11 From the Risk Analysis      Is the anticipated clinical study a  significant  or  non-significant  risk?
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 3/5/11 Is FDA Approval Required for  NO !!!
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Clinical Trials 2011 - ClicktoeditMastersubtitlestyle...

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