P A Lachenbruch
Affiliation: Food and Drug Administration
- Comparisons of two-part models with competitorsP A Lachenbruch
FDA CBER Division of Biostatistics and Epidemiology, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852 1448, USA
Stat Med 20:1215-34. 2001..In those cases, the two-part models are not far behind, although statistically significantly poorer with respect to power. Published in 2001 by John Wiley & Sons, Ltd...
- Potential use of the scan statistic for quality control in blood product manufacturingPeter A Lachenbruch
Division of Biostatistics, FDA CBER OBE, Rockville, MD 20852, USA
J Biopharm Stat 15:353-66. 2005..Monitoring plans based on scan statistics are developed to estimate the probability that a process that is under control...
- Proper metrics for clinical trials: transformations and other procedures to remove non-normality effectsPeter A Lachenbruch
FDA CBER Office of Biostatistics and Epidemiology, 1401 Rockville Pike, HFM 215, Rockville, MD 20852, USA
Stat Med 22:3823-42. 2003..The variability in outcomes with the different procedures demonstrates the importance of specifying such procedures a priori...
- Lot consistency as an equivalence problemP A Lachenbruch
U S FDA Center for Biologics Evaluation and Research, Rockville, Maryland 20852, USA
J Biopharm Stat 14:275-90. 2004..It appears to detect departures from equivalence that are not reflected by differences among group means...
- Power and sample size requirements for two-part modelsP A Lachenbruch
FDA CBER Office of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, MD 20852, USA
Stat Med 20:1235-8. 2001..We derive sample size calculations. We note that some modifications of this procedure may provide better tests if the non-zero responses are discrete. Published in 2001 by John Wiley & Sons, Ltd...
- Preventive vaccines against bioterrorism: evaluation of efficacy and safetyAmelia Dale Horne
Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, FDA, HFM 217, 1401 Rockville Pike, Rockville, MD 20852 1448, USA
Vaccine 23:84-90. 2004..We summarize the scientific bases for development and approval of vaccines and then discuss specific issues regarding vaccines against disease organisms that could potentially be used as weapons of bioterrorism...
- Fatalities caused by TRALILeslie Holness
Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
Transfus Med Rev 18:184-8. 2004..More data are needed to better describe the role of antibodies in these reactions. Greater awareness is crucial for the practitioner to be alert for signs and symptoms of TRALI and to be aware of the necessary steps in treatment...
- Analysis of studies to evaluate immune response to combination vaccinesA D Horne
Vaccine and Blood Product Evaluation Branch, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Rockville, MD 20852, USA
Clin Infect Dis 33:S306-11. 2001....
- Analysis of data with excess zerosPeter A Lachenbruch
FDA Center for Biologics Research and Review, Office of Biostatistics and Epidemiology, Rockville, MD, USA
Stat Methods Med Res 11:297-302. 2002..The second part of the paper summarizes results of a study of the size and power of two-part models. It proposes that two-part models are a useful alternative to the t-test and the Wilcoxon test...
- Biomarkers and surrogate endpoints in renal transplantation: present status and considerations for clinical trial designPeter A Lachenbruch
Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Rockville, MD, USA
Am J Transplant 4:451-7. 2004..This review addresses the concepts and possible strategies for use of predictor and surrogate biomarkers in the design of clinical trials in renal transplantation. The statistical concepts apply equally well to other organ grafts...
- Toward biomarkers for chronic graft-versus-host disease: National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: III. Biomarker Working Group ReportKirk R Schultz
British Columbia Children s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
Biol Blood Marrow Transplant 12:126-37. 2006..Both approaches have merit and should be pursued. The consistent treatment and standardized documentation needed to support biomarker studies are most likely to be satisfied in prospective clinical trials...
- Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group reportSteven Z Pavletic
National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892 1203, USA
Biol Blood Marrow Transplant 12:252-66. 2006..The proposed response criteria are based on current expert consensus opinion and are intended to improve consistency in the conduct and reporting of chronic GVHD trials, but their use remains to be demonstrated in practice...
- Some aspects of the application of internal pilot studiesPeter A Lachenbruch
US Food and Drug Administration, USA
Biom J 48:556-7; discussion 558. 2006..This is a discussion of the paper' Sample size recalculation in internal pilot study designs' by Tim Friede and Meinhard Kieser, appearing in this special issue on adaptive designs...
- Opening the adaptive toolboxJanet Wittes
Statistics Collaborative, 1625 Massachusetts Ave, NW, Washington, DC 20036, USA
Biom J 48:598-603; discussion 613-22. 2006..O'Neill, Sue-Jane Wang and John Lawrence; 'Confirmatory clinical trials with an adaptive design' by Armin Koch; and 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill...
- Developing international consensus on measures of improvement for patients with myositisPeter A Lachenbruch
FDA Center for Biologics Evaluation and Research, USA
Stat Methods Med Res 16:51-64. 2007..We discuss criteria for determining an acceptable rule that include both numerical measures and physician acceptance...
- Guest authorship, mortality reporting, and integrity in rofecoxib studiesPeter A Lachenbruch
JAMA 300:904; author reply 905-6. 2008