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pro vyhledávání: '"Thomas Permutt"'
Autor:
Thomas Permutt
Publikováno v:
Statistics in Biopharmaceutical Research. 12:45-53
Adjustment for covariates has been underused in trials intended to support approval of medical products. This underuse results partly from confusion about whether adjusting changes the thin...
Autor:
Thomas Permutt
Publikováno v:
Statistics in Biopharmaceutical Research. 12:137-141
The causal estimands of interest in a clinical trial are treatment effects, and a treatment effect is a comparison of the outcomes for the same patients, or for similar groups of patients, on diffe...
Autor:
Stephen J. Ruberg, William H. Crown, Jodi B Segal, Thomas Permutt, Thomas A. Louis, John Scott, Mark Rothmann
Publikováno v:
Pharmaceutical statisticsREFERENCES. 20(5)
Clinical trials are primarily conducted to understand the average effects treatments have on patients. However, patients are heterogeneous in the severity of the condition and in ways that affect what treatment effect they can expect. It is therefore
Autor:
Lisa M. LaVange, Julia A. Beaver, Robert N. Schuck, Christopher Leptak, Janet Woodcock, Steven Lemery, Rosane Charlab, Issam Zineh, Peter Stein, Hobart Rogers, Michael Pacanowski, E. David Litwack, Badrul A. Chowdhury, Gideon M. Blumenthal, Jonathan P. Jarow, Robert Temple, Thomas Permutt, Sarah E. Dorff
Publikováno v:
Clinical Pharmacology & Therapeutics. 104:282-289
Advances in our understanding of the molecular underpinnings of disease have spurred the development of targeted therapies and the use of precision medicine approaches in patient care. While targeted therapies have improved our capability to provide
Publikováno v:
Pharmaceutical Statistics. 16:378-392
In some randomized (drug versus placebo) clinical trials, the estimand of interest is the between-treatment difference in population means of a clinical endpoint that is free from the confounding effects of "rescue" medication (e.g., HbA1c change fro
Autor:
Thomas Permutt
Publikováno v:
Statistics in Biopharmaceutical Research. 10:233-235
Dropouts confound the treatment effect when the outcome and the dropout process both depend on subject characteristics. If dropout is unrelated to treatment, there is an unconfounded effect, but it...
Autor:
Thomas Permutt
Publikováno v:
Clinical trials (London, England). 16(4)
The proposed addendum to the International Conference on Harmonization document, Statistical Principles for Clinical Trials, can be read in two ways. There is a new framework for talking about estimands, but is it about fitting present methods into t
Autor:
Feng Li, Thomas Permutt
Publikováno v:
Pharmaceutical Statistics. 16:20-28
Dropouts from randomized trials, often for lack of efficacy or toxicity, have usually been handled as 'missing data'. We suggest that they are instead complete observations, just not numeric ones. We propose an exact test of the hypothesis of no drug
Autor:
Thomas Permutt, Lisa M. LaVange
Publikováno v:
Statistics in Medicine. 35:2853-2864
The issuance of a report in 2010 by the National Research Council (NRC) of the National Academy of Sciences entitled 'The Prevention and Treatment of Missing Data in Clinical Trials,' commissioned by the US Food and Drug Administration, had an immedi
Autor:
Thomas Permutt
Publikováno v:
Clinical pharmacology and therapeutics. 105(4)
It would often be of interest to know the effect of a drug compared to control in people who take the drug. However, different people will likely take the drug and the control. Thus, comparing takers of the drug to takers of the control does not yiel