Sponsored by the Food and Drug Administration and Johns Hopkins University

Masur Auditorium, NIH
May 20-21, 2004

Flyer (pdf, 253 KB)

Program and Available Presentations

Two of the Presentations for this workshop are available as Adobe PDF files requiring the free the free Adobe Reader. The PDF files may be opened in the browser or downloaded as self-extracting zip archives and opened off-line. Eight of the Presentations for this Workshop are available as self-extracting zip archives created with WinZip. The .exe archives should be downloaded to a computer and opened by double clicking the file; the WinZip self-extrator will open and the BROWSE button will allow selection of a location or folder for the PowerPoint (or PDF) file(s). Then click UNZIP to extract the file(s) to the selected folder; finally click CLOSE to close the extractor. File sizes for the downloads range from ~120 KB to 21,900 KB (21.9 MB). (Additonal Information on downloading free Adobe reader and using zip archives is available). To download individual presentations, see the Program below (file sizes are noted). Download All 10 Available Presentations (21.9 MB including one video clip)

Target Audience: FDA reviewers and managers, industry, and academia, statisticians and non-statisticians.

Goals:

• Communicate the underlying concepts of Bayesian design and analysis of clinical trials in non-technical terms.
• Illustrate the use of Bayesian approaches to clinical trials with case studies.
• Demonstrate how a Bayesian approach uses evidence in the decision making process.
• Review the experience of the Center for Devices and Radiological Health using Bayesian approaches
  and discuss the potential for application of Bayesian approaches in clinical trials of investigational pharmaceuticals.
• Discuss how studies using a Bayesian approach can satisfy regulatory requirements.