Sponsoring Section/Society: ASA BIOMETRICS
Session Slot: 8:30-10:20 Wednesday
Estimated Audience Size: 400-500
AudioVisual Request: Overhead and slides
Session Title: Statistics and Policy Setting at the Food and
Drug Administration
Theme Session: Yes
Applied Session: Yes
Session Organizer: Ellenberg, Susan S. Center for Biologics Evaluation and Research, FDA
Address: Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, HFM-210 Rockville, MD 20852-1448
Phone: (301)-827-3034
Fax: (301)-827-3529
Email: ellenberg@cber.fda.gov
Session Timing: 110 minutes total (Sorry about format):
110 minutes total Opening Remarks by Chair - 5 or 0 minutes First Speaker - 30 minutes (or 25) Second Speaker - 30 minutes Third Speaker - 30 minutes Discussant - 10 minutes (or none) Floor Discussion - 10 minutes (or 5 or 15)
Session Chair: Cambell, Gregory Center for Devices and Radiological Health, FDA
Address: Director, Division of Biostatistics Center for Devices and Radiological Health, FDA 1350 Piccard Drive, HFZ-542 Rockville, MD 20850
Phone: (301)-594-0616
Fax: (301)-443-8559
Email: campbell@cdrh.fda.gov
1. Statistics, Statisticians and Policymaking at the FDA
Ellenberg, Susan S., Center for Biologics Evaluation and Research, FDA
Address: Center for Biologics Evaluation and Research 1401 Rockville Pike, HFM-210 Rockville MD 20852-1448
Phone: (301)-827-3034
Fax: (301)-827-3529
Email: ellenberg@cber.fda.gov
Abstract: Statisticians at the Food and Drug Administration are intimately involved with the development and evaluation of new medical products. They assess study designs and data bases from preclinical investigations through the definitive clinical trials. This is perhaps the most well-understood role of statisticians at the FDA. But much effort in any regulatory agency goes into the development (and revision) of regulations, guidance documents, and other policy development activities. Statisticians contribute to such efforts in many ways. Some contributions relate to technical statistical issues, such as setting thresholds for establishing the purity or potency of a biological product on the basis of a laboratory assay. Others relate to broader issues, where statistics is one of several disciplines relevant to the policy issue in question. Examples would be policies on collecting and evaluating data on age and gender effects of new medical interventions; on use of appropriate control groups for clinical trials of new pharmaceuticals; and on approaches to ensuring the integrity of data submitted in support of marketing applications. Statisticians with long experience at the FDA or in medical research generally will frequently be part of policy teams in areas that are not specifically statistical at all, but that require in-depth knowledge of issues in drug development and/or clinical research.
2. Active Control Equivalence Trials in Drug Development
Temple, Robert J., Center for Drug Evaluation and Research, FDA
Address: Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane, HFD-101 Rockville, MD 20857-001
Phone: (301)-594-6758
Fax: (301)-594-5298
Email: temple@cder.fda.gov
Abstract:
3. The Role of the Statistician on FDA Advisory Committees
D'Agostino, Sr., Ralph, Boston University
Address: Statistics and Consulting Unit Department of Mathematics Boston University 111 Cummington Street Boston, MA 02215
Phone: (617)-353-2767
Fax: (617)-353-8100
Email: ralph@math.bu.edu
Abstract: Each FDA Advisory Committee has a statistician member, who can play a major role in the committee's deliberations and ultimately on the decision and policies of the FDA divisions. The statistician is asked repeatedly to be the primary evaluator of the design, execution and analysis aspects of clinical trials, observational studies and post-marketing surveys. With appropriate diligence to the substantive questions under discussion, including the statistical and non-statistical aspects, the statistician can be extremely influential. He/she can bring a new level of rigor to the Advisory Committee. Often the committee meetings offer an ideal setting for promulgating statistical concepts into the medical arena. In this talk I present reflections on my experience serving on advisory commitees, experience that started in 1974. I will use topics including study design, study population, interim analysis, longitudinal analysis, analysis of cluster data, multiple comparison, multiple testing, meta-analysis and label comprehension as examples to illustrate where, I believe, advisory committee statisticians have made tremendous impact. I will also discuss aspects of a statistician that are instrumental in being a successful advisory committee statistician.
Discussant: O'Neill, Robert T. Center for Drug Evaluation and Research, FDA
Address: Center for Drug Evaluation and Research, FDA 5600 Fishers Lane, HFD-700 Rockville, MD 2085a7-001
Phone: (301)-827-3195
Fax: (301)-480-2825
Email: oneill@cder.fda.gov
List of speakers who are nonmembers: Temple, Robert J.