Zobrazeno 1 - 10
of 22
pro vyhledávání: '"Gregory G Enas"'
Publikováno v:
Statistics in Medicine. 30:2601-2621
We propose a novel recursive partitioning method for identifying subgroups of subjects with enhanced treatment effects based on a differential effect search algorithm. The idea is to build a collection of subgroups by recursively partitioning a datab
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::12ff569e656d03605bf57e68de2c5f61
https://doi.org/10.1002/sim.4289
https://doi.org/10.1002/sim.4289
Autor:
Gregory G. Enas, Jonathan Denne
Publikováno v:
Drug Information Journal. 42:131-138
In the context of a New Drug Application in the United States, the term “substantial evidence” of clinical efficacy is usually understood to mean two well-controlled confirmatory studies in which a statistically significant difference is shown on
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fc837eb83aae6939bb9b1a30627aeae0
https://doi.org/10.1177/009286150804200205
https://doi.org/10.1177/009286150804200205
Autor:
Gregory G. Enas, William J. Huster
Publikováno v:
Statistics in Medicine. 17:1829-1838
Much has been published on various aspects of data analysis and reporting from clinical trials within the biopharmaceutical environment. This ranges from regulatory guidelines on the format and content of registration dossiers to recommendations on d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8dd2bc813756bec4e35014cc1a9781ef
https://doi.org/10.1002/(sici)1097-0258(19980815/30)17:15/16<1829::aid-sim985>3.0.co
https://doi.org/10.1002/(sici)1097-0258(19980815/30)17:15/16<1829::aid-sim985>3.0.co
Autor:
Gregory G. Enas, Frank W. Rockhold
Publikováno v:
Pharmaceutical statistics. 10(5)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3097d007bd47a45261a5facbfba56f0a
https://pubmed.ncbi.nlm.nih.gov/21928353
https://pubmed.ncbi.nlm.nih.gov/21928353
Autor:
Gregory G. Enas, Frank W. Rockhold
Publikováno v:
Statistics in Medicine. 12:471-479
The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring is a continuous process in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1035ede838489e4197524d374b359a00
https://doi.org/10.1002/sim.4780120512
https://doi.org/10.1002/sim.4780120512
Autor:
Walter W. Offen, Gregory G. Enas
Publikováno v:
Journal of Biopharmaceutical Statistics. 3:13-22
We consider the problem of stopping a clinical trial before its scheduled termination due to the apparent ineffectiveness of the experimental therapy, as compared with a control. We propose a simple-to-implement, intuitive decision rule based on the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8c42bdb7cbc4a450d4df2b64a96108ba
https://doi.org/10.1080/10543409308835046
https://doi.org/10.1080/10543409308835046
Autor:
Gregory G. Enas
Publikováno v:
Drug Information Journal. 25:439-446
While not required for every adverse event, inferential statistical methods can be used both formally and informally to help characterize the safety profile of a new drug and help guide the resulting inferences to the broader population. Examples of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d157a89b70ca7cd93dbcf18808eecfa6
https://doi.org/10.1177/009286159102500314
https://doi.org/10.1177/009286159102500314
Publikováno v:
Drug Information Journal. 24:541-548
“PostStudy Anxiety” syndrome is our term for the feeling of ill-being at the end of a randomized clinical trial upon finding that the randomized groups differ to a disquieting degree with respect t...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::03bccd93c94573350d6c770e18a214b9
https://doi.org/10.1177/009286159002400312
https://doi.org/10.1177/009286159002400312
Publikováno v:
Depression. 1:105-107
Unexpected clinical worsening has been described anecdotally during pharmacotherapy for depression. We analyzed data front 7,974 patients in double-blind, controlled trials (fluoxetine, placebo, tricyclics; mood/nonmood disorders). Paradoxical worsen
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::80a2b8a1ee1d4fa4febbfd23f1f63772
https://doi.org/10.1002/depr.3050010207
https://doi.org/10.1002/depr.3050010207
Autor:
David J. Goldstein, Gregory G. Enas
Publikováno v:
Statistics in medicine. 14(9-10)
Assessment of clinical trial safety data for industry, regulatory agencies, medical practitioners and patients requires definition and measurement, monitoring, and overall analysis. Prospective 'safety' definitions and reliable measurement tools redu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6f8f59896c8fda5eb6d1d4f0b4f38e82
https://pubmed.ncbi.nlm.nih.gov/7569503
https://pubmed.ncbi.nlm.nih.gov/7569503