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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012

SCIENTIFIC ADVANCES

Contributed by Dr. Ed Korn

Dr. Ed Korn makes numerous invaluable contributions to the statistical planning, monitoring, and evaluation of the NCI’s national program of therapeutic clinical trials, as well as major contributions to the development of new statistical methodology for clinical trials. Recent contributions include discussions of:

  • auditing strategies for progression-free survival results in unblinded trials
  • new inefficacy/futility interim monitoring plans
  • the need to report inefficacy/futility interim monitoring plans in the reports of trial results
  • trial designs that utilize biomarkers
  • the uses of causal inference
  • outcome-adaptive randomization (a component of some adaptive trial designs)

Much of this research is performed collaboratively with other BRB members and is summarized elsewhere in this report. Dr. Korn has also led a project (and publication) to evaluate the accrual experience of NCI Cooperative Group trials, with the eventual aim of offering quality improvement to the clinical trials process. In addition, Dr. Korn continues his long-standing research on the methodology of analyzing health surveys.

Dodd LE, Korn EL, Freidlin B, Gray R, Bhattacharya S. An audit strategy for progression-free survival. Biometrics (In press).

Freidlin B, McShane LM, and Korn EL. Randomized clinical trials with biomarkers: Design issues. J Natl Cancer Inst 2010:102;152-160. http://www.ncbi.nlm.nih.gov/pubmed/20075367

Freidlin B, Korn EL. Biomarker-adaptive clinical trial designs. Pharmacogenomics 2010:11;1679-1682. http://www.ncbi.nlm.nih.gov/pubmed/21142910

Freidlin B, Korn EL, Gray R. A general inefficacy interim monitoring rule for randomized clinical trials. Clin Trials 2010:7;197-208. http://www.ncbi.nlm.nih.gov/pubmed/20423925

Graubard BI, Korn EL. Conditional logistic regression with survey data. Stat Biopharm Res (In press).

Korn EL, Freidlin B. Causal inference for definitive clinical endpoints in a randomized clinical trial with intervening nonrandomized treatments. J Clin Oncol 2010:28;3800-3802. http://www.ncbi.nlm.nih.gov/pubmed/20660828

Korn EL, Freidlin B, Mooney M. Bias and trials stopped early for benefit (Reply). JAMA 2010:304;157-158. http://www.ncbi.nlm.nih.gov/pubmed/20628125

Korn EL, Dodd LE, Freidlin B. Measurement error in the timing of events: Effect on survival analyses in randomized clinical trials. Clin Trials 2010:7;626-633. http://www.ncbi.nlm.nih.gov/pubmed/20819840

Korn EL, Freidlin B, Mooney M, Abrams JS. Accrual experience of NCI cooperative group phase III trials activated in 2000-2007. J Clin Oncol 2010:28;5197-5201. http://www.ncbi.nlm.nih.gov/pubmed/21060029

Korn EL, Freidlin B. Outcome-adaptive randomization: Is it useful? J Clin Oncol 2011:29;71-776. http://www.ncbi.nlm.nih.gov/pubmed/21172882

Korn EL, Freidlin B. Inefficacy monitoring procedures in randomized clinical trials: The need to report. Am J Bioethics 2011:11;2-10. http://www.ncbi.nlm.nih.gov/pubmed/21400374

Li Y, Graubard BI, Korn EL. Application of nonparametric quantile regression to body mass index percentile curves from survey data. Stat Med 2010:29;558-572. http://www.ncbi.nlm.nih.gov/pubmed/20013898

Xu T-M, Zhang X, Oh HS, Boyd RL, Korn EL, Baumrind S. A randomized clinical trial (RCT) comparing control of maxillary anchorage using two retraction techniques. Am J Orthod Dentofacial Orthop 2010:138;554.e1-9. http://www.ncbi.nlm.nih.gov/pubmed/21055588

Korn EL, Freidlin B, Abrams JS. Overall survival as the outcome for randomized clinical trials with effective subsequent therapies. J Clin Oncol 2011:29;2439-42. http://www.ncbi.nlm.nih.gov/pubmed/21555691

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