Bio-Medicine.org eports, “U.S. Food and Drug Administration issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.”
The article quotes FDA Commissioner Margaret A. Hamburg, M.D., as saying the guidance is “consistent with the FDA’s commitment to streamline clinical trials.”
On a related note, the agency notes that due to its redesigned Web site, the Good Clinical Practice Program has moved. Further details are available…
More clinical trials information is available from the following sources:
• Parenteral Drug Assn.’s Clinical Trial Materials Interest Group.
• Intl. Society for Pharmaceutical Engineering’s 45-minute Webinar, “Investigational Products: Tackling Packaging Challenges for Clinical Trials.” Cost: $49 for members; $149 for nonmembers.
• FDA’s Compliance & Enforcement information links.
--Jim Butschli, Editor, Healthcare Packaging magazine
