D L DeMets

Summary

Affiliation: University of Wisconsin
Country: USA

Publications

  1. ncbi request reprint Monitoring clinical trials: issues and controversies regarding confidentiality
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, Washington 98195 7232, USA
    Stat Med 21:2843-51. 2002
  2. doi request reprint Current development in clinical trials: issues old and new
    David L Demets
    Department of Biostatistics and Medical Informatics, University of Wisconsin Madison, WI, U S A
    Stat Med 31:2944-54. 2012
  3. ncbi request reprint Futility approaches to interim monitoring by data monitoring committees
    David L Demets
    University of Wisconsin Madison, Department of Biostatistics and Medical Informatics, Madison, Wisconsin 53792 4675, USA
    Clin Trials 3:522-9. 2006
  4. ncbi request reprint Training of the next generation of biostatisticians: a call to action in the U.S
    David 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
  5. ncbi request reprint An Institutional Review Board dilemma: responsible for safety monitoring but not in control
    David 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
  6. ncbi request reprint Issues in regulatory guidelines for data monitoring committees
    David 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
  7. ncbi request reprint Liability issues for data monitoring committee members
    David L Demets
    University of Wisconsin, Madison, WI, USA
    Clin Trials 1:525-31. 2004
  8. ncbi request reprint The independent statistician for data monitoring committees
    David 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
  9. ncbi request reprint Statistical issues in interpreting clinical trials
    D 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
  10. ncbi request reprint The agonising negative trend in monitoring of clinical trials
    D L DeMets
    Department of Biostatistics, University of Wisconsin Madison, USA
    Lancet 354:1983-8. 1999

Research Grants

Detail Information

Publications30

  1. ncbi request reprint Monitoring clinical trials: issues and controversies regarding confidentiality
    Thomas 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...
  2. doi request reprint Current development in clinical trials: issues old and new
    David 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...
  3. ncbi request reprint Futility approaches to interim monitoring by data monitoring committees
    David 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...
  4. ncbi request reprint Training of the next generation of biostatisticians: a call to action in the U.S
    David 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)...
  5. ncbi request reprint An Institutional Review Board dilemma: responsible for safety monitoring but not in control
    David 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...
  6. ncbi request reprint Issues in regulatory guidelines for data monitoring committees
    David 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...
  7. ncbi request reprint Liability issues for data monitoring committee members
    David 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...
  8. ncbi request reprint The independent statistician for data monitoring committees
    David 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...
  9. ncbi request reprint Statistical issues in interpreting clinical trials
    D 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...
  10. ncbi request reprint The agonising negative trend in monitoring of clinical trials
    D L DeMets
    Department of Biostatistics, University of Wisconsin Madison, USA
    Lancet 354:1983-8. 1999
    ....
  11. ncbi request reprint Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancer
    Richard 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...
  12. ncbi request reprint Mastectomy and oophorectomy by menstrual cycle phase in women with operable breast cancer
    Richard 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...
  13. ncbi request reprint Her-2/neu overexpression and response to oophorectomy plus tamoxifen adjuvant therapy in estrogen receptor-positive premenopausal women with operable breast cancer
    Richard R Love
    Departments of Medicine and Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI 53726, USA
    J Clin Oncol 21:453-7. 2003
    ....
  14. doi request reprint Review of draft FDA adaptive design guidance
    Thomas 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...
  15. ncbi request reprint Design and analysis of group sequential clinical trials with multiple primary endpoints
    Michael 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...
  16. ncbi request reprint Clinical trials in the new millennium
    David 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...
  17. ncbi request reprint Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study
    Milton 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...
  18. ncbi request reprint Toward protecting the safety of participants in clinical trials
    Robert 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...
  19. ncbi request reprint Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis
    Y 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...
  20. ncbi request reprint 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
  21. ncbi request reprint Rationale and design of the enoximone clinical trials program
    Brian D Lowes
    University of Colorado Health Sciences Center, Denver, Colorado 80262, USA
    J Card Fail 11:659-69. 2005
    ..Based on these data, the ability of enoximone to deliver safe and efficacious palliative treatment of advanced/ultra-advanced chronic heart failure is being evaluated in Phase III clinical trials...
  22. ncbi request reprint Lessons learned from recent cardiovascular clinical trials: Part I
    David L Demets
    Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA
    Circulation 106:746-51. 2002
  23. ncbi request reprint Marketing drugs too early in testing
    Colin B Begg
    Science 312:195. 2006
  24. ncbi request reprint Conditional and unconditional confidence intervals following a group sequential test
    Xiaoyin 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...
  25. ncbi request reprint Lessons learned from recent cardiovascular clinical trials: Part II
    David L Demets
    Duke Clinical Research Institute and the Division of Cardiology, Duke University Medical Center, Durham, NC 27715, USA
    Circulation 106:880-6. 2002
  26. ncbi request reprint Principles from clinical trials relevant to clinical practice: Part I
    Robert M Califf
    Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA
    Circulation 106:1015-21. 2002
  27. ncbi request reprint Clinical effects of endothelin receptor antagonism with bosentan in patients with severe chronic heart failure: results of a pilot study
    Milton Packer
    College of Physicians and Surgeons, Columbia University, New York, New York, USA
    J Card Fail 11:12-20. 2005
    ..Endothelin receptor antagonism produces favorable short-term hemodynamic effects in heart failure, but the clinical effects of longer term therapy have not been evaluated...
  28. ncbi request reprint Conditional bias of point estimates following a group sequential test
    Xiaoyin 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...
  29. ncbi request reprint Principles from clinical trials relevant to clinical practice: Part II
    Robert M Califf
    Duke Clinical Research Institute and the Division of Cardiology, Duke University Medical Center, Durham, NC, USA
    Circulation 106:1172-5. 2002
  30. ncbi request reprint Increasing the sample size when the unblinded interim result is promising
    Y 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 Grants23

  1. STATISTICAL PROBLEMS IN CANCER RESEARCH
    David 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...
  2. STATISTICAL PROBLEMS IN CANCER RESEARCH
    David DeMets; Fiscal Year: 2001
    ..These design issues were motivated by trials encountered in our collaboration with cancer center investigators. ..
  3. SUMMER INSTITUTE FOR TRAINING IN BIOSTATISTICS
    David 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) ..
  4. Interdisciplinary Training Program in Cardiovascular and Pulmonary Biostatistics
    David DeMets; Fiscal Year: 2007
    ..End of Abstract) ..
  5. STATISTICAL PROBLEMS IN CANCER RESEARCH
    David 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...