L M McShane
Affiliation: National Institutes of Health
- Reporting recommendations for tumor marker prognostic studies (remark)L M McShane
Biometric Research Branch, DCTD, U S National Cancer Institute, Bethesda, MD 20892, USA
Exp Oncol 28:99-105. 2006....
- Criteria for the use of omics-based predictors in clinical trials: explanation and elaborationLisa M McShane
Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Room 5W130, MSC 9735, 9609 Medical Center Drive, Bethesda, MD 20892 9735, USA
BMC Med 11:220. 2013..The US National Cancer Institute plans to refer to these guidelines for review of proposals for studies involving omics tests, and it is hoped that other sponsors will adopt the checklist as well...
- Criteria for the use of omics-based predictors in clinical trialsLisa M McShane
Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA
Nature 502:317-20. 2013..The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy. ..
- Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaborationDouglas G Altman
Centre for Statistics in Medicine, University of Oxford, UK
BMC Med 10:51. 2012..In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report...
- Statistical challenges in the development and evaluation of marker-based clinical testsLisa M McShane
Biometric Research Branch and Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, 6130 Executive Boulevard, EPN 8126, Bethesda, MD 20892 7434, USA
BMC Med 10:52. 2012..The focus of this commentary is the many statistical challenges in translational marker research, specifically in the development and validation of marker-based tests that have clinical utility for therapeutic decision-making...
- Evaluation of normalization methods for two-channel microRNA microarraysYingdong Zhao
Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA
J Transl Med 8:69. 2010..Findings from previous studies have sometimes been inconclusive or contradictory. Further studies to determine optimal normalization methods for miR microarrays are needed...
- Reproducibility of p53 immunohistochemistry in bladder tumors. National Cancer Institute, Bladder Tumor Marker NetworkL M McShane
National Cancer Institute, Bethesda, Maryland 20892 7434, USA
Clin Cancer Res 6:1854-64. 2000..Standardization of staining protocols and selection of a uniform threshold for binary interpretation of results may improve assay reproducibility between laboratories...
- Epstein-Barr virus microRNAs and lung cancerJ Koshiol
Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA
Br J Cancer 105:320-6. 2011..We conducted the first analysis of viral microRNAs (miRNAs) in lung cancer, with a focus on Epstein-Barr virus (EBV)...
- Relationships of serum androgens and estrogens to prostate cancer risk: results from a prospective study in FinlandJ F Dorgan
Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland 20892 7374, USA
Cancer Epidemiol Biomarkers Prev 7:1069-74. 1998..These results do not support a strong relationship of serum androgens and estrogens with prostate cancer in smokers. Within-person variation in concentrations of some hormones may have contributed to the lack of significant associations...
- Identifying pre-post chemotherapy differences in gene expression in breast tumours: a statistical method appropriate for this aimE L Korn
Biometric Research Branch, EPN 8128, National Cancer Institute, National Institutes of Health, Bethesda MD 20892, USA
Br J Cancer 86:1093-6. 2002..These findings were not reported by the original investigators who analysed the data using cluster analysis techniques...
- Latent class modeling approaches for assessing diagnostic error without a gold standard: with applications to p53 immunohistochemical assays in bladder tumorsP S Albert
Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892 7434, USA
Biometrics 57:610-9. 2001..These mixture models are shown to offer an improvement over other methods in a variety of settings, but we caution that, in general, care must be taken in applying latent class models...
- Covariate measurement error adjustment for matched case-control studiesL M McShane
National Cancer Institute, Biometric Research Branch, DCTD, Bethesda, Maryland 20892 7434, USA
Biometrics 57:62-73. 2001..We present an example of the procedure applied to data from a matched case-control study of prostate cancer and serum hormone levels, and we compare its performance to that of regression calibration procedures...
- Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeldt-Jakob disease in humansP Brown
Laboratory of CNS Studies, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland 20892 4122, USA
Transfusion 39:1169-78. 1999....
- Cytokine and immunoglobulin concentrations in cervical secretions: reproducibility of the Weck-cel collection instrument and correlates of immune measuresA Hildesheim
Interdisciplinary Studies Section, Environmental Epidemiology Branch, DCEG, National Cancer Institute, Bethesda, MD 20892 7374, USA
J Immunol Methods 225:131-43. 1999..In addition, various correlates of cytokine and immunoglobulin concentrations were identified...
- Measuring cell proliferation in the rectal mucosa. comparing bromodeoxyuridine (BrdU) and proliferating cell nuclear antigen (PCNA) assaysM Kulldorff
National Cancer Institute, Bethesda, MD, USA
J Clin Epidemiol 53:875-83. 2000..When used in a clinical or epidemiological setting, it is important to take multiple biopsies at multiple time points...
- REporting recommendations for tumour MARKer prognostic studies (REMARK)L M McShane
US National Cancer Institute, Bethesda, MD 20892, USA
Br J Cancer 93:387-91. 2005....
- Questioning the utility of pooling samples in microarray experiments with cell linesL Lusa
Department of Experimental Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy
Int J Biol Markers 21:67-73. 2006..These findings indicate that pooling samples in microarray experiments where the biological variability is expected to be small might not be helpful and could even decrease one's ability to identify differentially expressed genes...