Other Presentations

Janet Woodcock, MD. “Defining Quality in Clinical Trials.”

Presented at the FDA/DIA Data Quality meeting in May 2007, this slide deck outlines the FDA’s new approach to defining quality and risk in clinical data, and specifically addresses the point that high quality data are not necessarily perfect data. (presentation begins on slide 45) http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4368s1-07-Guest-Califf_files/frame.htm#slide0631.htm

Michael Marcarelli, PharmD. “Device Bioresearch Monitoring: Perspectives.”

Dr. Marcarelli is the head of BIMO in CDRH, the agency’s devices division. In this presentation he talks about how CDRH BIMO audits PMAs, which are one type of devices regulatory submission. www.fda.gov/cdrh/present/advamed-052505-marcarelli.PPT

Stephen Wilson and Feng Zhou. “A Statistical Reviewer’s Perspective.”

Drs. Wilson and Zhou discuss reviewing electronic submissions using SDTM and ADaM. http://www.fda.gov/cder/present/DIA2006/Zhou.pps

Armando Oliva, MD. “The Review of SDTM Datasets at CDER.”

Dr. Oliva describes how SDTM has improved the agency’s ability to review submissions, and how it enables the use of internally developed review tools. http://www.fda.gov/oc/datacouncil/meetings/oliva.pdf

James Hung. “A Regulatory Perspective on Adaptive Randomization.”

A discussion of some considerations when utilizing adaptive randomization in clinical trials. http://www.fda.gov/cder/present/DIA2005/Hung.pdf

Armando Oliva. “Guidance-Compliant eCTDs: Module 5.”

A review of the clinical trials module of the eCTD submission guidance discussing what information should be included where. http://www.fda.gov/cder/meeting/eCTD_4_2005/oliva.ppt