Research Topics
Species | D L DeMetsSummaryAffiliation: University of Wisconsin Country: USA Publications
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Publications
Monitoring clinical trials: issues and controversies regarding confidentialityThomas R Fleming
Department of Biostatistics, University of Washington, Seattle, Washington 98195-7232, USA
Stat Med 21:2843-51. 2002..However, to address the ethical imperative to protect the interests of study participants, the DMC itself should have access to unblinded efficacy and safety results...
Current development in clinical trials: issues old and newDavid L Demets
Department of Biostatistics and Medical Informatics, University of Wisconsin Madison, WI, U S A
Stat Med 31:2944-54. 2012..Comparative effectiveness studies are of increasing interest but present major design and analysis issues. Forces external to the trial are also becoming more common...- Futility approaches to interim monitoring by data monitoring committeesDavid L Demets
University of Wisconsin Madison, Department of Biostatistics and Medical Informatics, Madison, Wisconsin 53792 4675, USA
Clin Trials 3:522-9. 2006..These will be briefly summarized. However useful these methods might be, they alone are not adequate to make the decision and the DMC must take into account other issues to make a judgment... - Training of the next generation of biostatisticians: a call to action in the U.SDavid L Demets
Department of Biostatistics and Medical Informatics, University of Wisconsin, School of Medicine and Public Health, 600 Highland Avenue, Box 4675, Madison, WI 53792, USA
Stat Med 25:3415-29. 2006..Some progress has been made through a new biostatistics training program with emphasis in bioinformatics sponsored by the National Institute of General Medical Sciences (NIGMS)... - An Institutional Review Board dilemma: responsible for safety monitoring but not in controlDavid L Demets
Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, K6 446 CSC, Madison, WI 53792 4675, USA
Clin Trials 3:142-8. 2006..We propose the establishment of institutional data monitoring committees and appropriate informatics infrastructure to monitor local trials... - Issues in regulatory guidelines for data monitoring committeesDavid DeMets
Department of Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, Madison, WI 53792 4675, USA
Clin Trials 1:162-9. 2004..This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute... - Liability issues for data monitoring committee membersDavid L Demets
University of Wisconsin, Madison, WI, USA
Clin Trials 1:525-31. 2004..This paper discusses these issues and suggests sample language for indemnification agreements to protect DMC members. This type of language should be included in DMC charters and in all consulting agreements signed by DMC members... - The independent statistician for data monitoring committeesDavid L Demets
Department of Biostatistics and Medical Informatics, University of Wisconsin Madison, 600 Highland Avenue, Box 4675, Madison, WI 53792 4675, USA
Stat Med 23:1513-7. 2004..These views are based on having served as members of many DMCs as well as having been the independent statistician for several trials... - Statistical issues in interpreting clinical trialsD L DeMets
Department of Biostatistics and Medical Informatics, University of Wisconsin Madison, 600 Highland Avenue, K6 446, Madison, WI 53792 4675, USA
J Intern Med 255:529-37. 2004..Several issues are described that make interpretation of analyses challenging. These include the intent-to-treat principle, the use of surrogate outcome measures, subgroup analyses, missing data and noninferiority trials... - The agonising negative trend in monitoring of clinical trialsD L DeMets
Department of Biostatistics, University of Wisconsin Madison, USA
Lancet 354:1983-8. 1999.... - Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancerRichard R Love
University of Wisconsin Comprehensive Cancer Center, 610 Walnut Street, Madison, WI 53705 2397, USA
J Clin Oncol 20:2559-66. 2002..Approximately 350,000 new cases of breast cancer are diagnosed annually in premenopausal Asian women who have lower levels of estrogen than western women... - Mastectomy and oophorectomy by menstrual cycle phase in women with operable breast cancerRichard R Love
Department of Medicine, Section of Medical Oncology, University of Wisconsin School of Medicine, Madison, 53705, USA
J Natl Cancer Inst 94:662-9. 2002..We investigated this question in the context of a clinical trial comparing mastectomy alone with mastectomy plus adjuvant oophorectomy and tamoxifen in premenopausal women with operable breast cancer... - Her-2/neu overexpression and response to oophorectomy plus tamoxifen adjuvant therapy in estrogen receptor-positive premenopausal women with operable breast cancerRichard R Love
Departments of Medicine and Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI 53726, USA
J Clin Oncol 21:453-7. 2003.... - Review of draft FDA adaptive design guidanceThomas Cook
Department of Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA
J Biopharm Stat 20:1132-42. 2010..While scarce resources and ethical imperatives motivate serious consideration of adaptive designs, researchers should be fully aware of the advantages and disadvantages of adaptive designs and adopt them cautiously... - Design and analysis of group sequential clinical trials with multiple primary endpointsMichael R Kosorok
Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin 53792, USA
Biometrics 60:134-45. 2004..The method is demonstrated with two simulated examples based on the MERIT-HF study... - Clinical trials in the new millenniumDavid L Demets
Department of Biostatistics, University of Wisconsin-Madison, 600 Highland Avenue, K6/446A CSC, Madison, Wisconsin 53792-4675, USA
Stat Med 21:2779-87. 2002..Those and many other challenges face us in the decade ahead. It is truly an exciting time with new opportunities for the RCT to contribute to medicine and health care or prevention... - Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) studyMilton Packer
College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA
Circulation 106:2194-9. 2002..Beta-blocking agents improve functional status and reduce morbidity in mild-to-moderate heart failure, but it is not known whether they produce such benefits in severe heart failure... - Toward protecting the safety of participants in clinical trialsRobert M Califf
Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27715, USA
Control Clin Trials 24:256-71. 2003..DMC composition and functions should be standardized and regulations should be harmonized nationally and internationally. Finally, there should be a concerted effort to study the efficacy of various components of the system... - Monitoring mortality at interim analyses while testing a composite endpoint at the final analysisY H Joshua Chen
Merck Research Laboratories, Blue Bell, PA 19422, USA
Control Clin Trials 24:16-27. 2003..A simulation study shows that the two switching-endpoint procedures allow a trial to be stopped early due to a clinically relevant benefit in the mortality while preserving the overall alpha level... - Re: The influence of menstrual cycle phase on surgical treatment of primary breast cancer: have we made any progress over the past 13 years?Richard R Love
J Natl Cancer Inst 94:1722-3; author reply 1723. 2002 - Rationale and design of the enoximone clinical trials programBrian D Lowes
University of Colorado Health Sciences Center, Denver, Colorado 80262, USA
J Card Fail 11:659-69. 2005.... - Lessons learned from recent cardiovascular clinical trials: Part IDavid L Demets
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA
Circulation 106:746-51. 2002 - Marketing drugs too early in testingColin B Begg
Science 312:195. 2006 - Conditional and unconditional confidence intervals following a group sequential testXiaoyin Fan
Merck Research Laboratory, Merck and Co, Inc West Point, Pennsylvania, USA
J Biopharm Stat 16:107-22. 2006..Differences between the conditional and unconditional CI's and their respective strengths are also discussed... - Lessons learned from recent cardiovascular clinical trials: Part IIDavid L Demets
Duke Clinical Research Institute and the Division of Cardiology, Duke University Medical Center, Durham, NC 27715, USA
Circulation 106:880-6. 2002 - Principles from clinical trials relevant to clinical practice: Part IRobert M Califf
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA
Circulation 106:1015-21. 2002 - Clinical effects of endothelin receptor antagonism with bosentan in patients with severe chronic heart failure: results of a pilot studyMilton Packer
College of Physicians and Surgeons, Columbia University, New York, New York, USA
J Card Fail 11:12-20. 2005.... - Conditional bias of point estimates following a group sequential testXiaoyin Frank Fan
Merck Research Laboratories, Merck and Co, Inc, West Point, Pennsylvania 19486, USA
J Biopharm Stat 14:505-30. 2004..The results of Monte-Carlo studies show that the proposed estimators can provide a much smaller conditional bias and MSE than the naive MLE and a Whitebead's bias reduced estimator... - Principles from clinical trials relevant to clinical practice: Part IIRobert M Califf
Duke Clinical Research Institute and the Division of Cardiology, Duke University Medical Center, Durham, NC, USA
Circulation 106:1172-5. 2002 - Increasing the sample size when the unblinded interim result is promisingY H Joshua Chen
Merck Research Laboratories, Blue Bell, PA 19422, USA
Stat Med 23:1023-38. 2004..If there are two or more interim analyses in a group sequential trial, our simulation study shows that the type I error rate is also well controlled...
Research Grants
- STATISTICAL PROBLEMS IN CANCER RESEARCHDavid DeMets; Fiscal Year: 1992..Finally, existing software which implements past research as well as that proposed will be put into user friendly, well documented packages for distribution to colleagues...
- STATISTICAL PROBLEMS IN CANCER RESEARCHDavid DeMets; Fiscal Year: 2001..These design issues were motivated by trials encountered in our collaboration with cancer center investigators. ..
- SUMMER INSTITUTE FOR TRAINING IN BIOSTATISTICSDavid DeMets; Fiscal Year: 2007..Through this process, we believe that students will see the opportunities that biostatistics provides to contribute in a meaningful way to the progress of medical and population health research. (End of Abstract) ..
- Interdisciplinary Training Program in Cardiovascular and Pulmonary BiostatisticsDavid DeMets; Fiscal Year: 2007..End of Abstract) ..
- STATISTICAL PROBLEMS IN CANCER RESEARCHDavid DeMets; Fiscal Year: 1993..We also plan to draft a clinicians handbook as a nontechnical introduction to data monitoring, including discussion of the alpha spending function, as well as many examples from completed trials...