Zobrazeno 1 - 10
of 26
pro vyhledávání: '"Damian McEntegart"'
Autor:
Sonya, Eremenco, Stephen Joel, Coons, Jean, Paty, Karin, Coyne, Antonia V, Bennett, Damian, McEntegart, Vladimir, Zah
Publikováno v:
Value in Health. 17:501-516
The objective of this report was to address the use and mixing of data collection modes within and between trials in which patient-reported outcome (PRO) end points are intended to be used to support medical product labeling. The report first address
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f5c267a200afdbb5f4c755a8d7b5e0a1
https://doi.org/10.1016/j.jval.2014.06.005
https://doi.org/10.1016/j.jval.2014.06.005
Publikováno v:
Pharmaceutical Statistics. 12:243-253
Re-randomization test has been considered as a robust alternative to the traditional population model-based methods for analyzing randomized clinical trials. This is especially so when the clinical trials are randomized according to minimization, whi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::699eaec6e2acaa331b5ee2941d50d032
https://doi.org/10.1002/pst.1577
https://doi.org/10.1002/pst.1577
Publikováno v:
The Open Clinical Trials Journal. 3:26-31
Phase I and early Phase II studies generally have the aim of establishing the safety, tolerability and pharmacokinetics of one or more doses and formulations. Traditionally many of these studies have tended to be conducted at a single site so that th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::22fcec097bc3a22eb661054bf26a62ff
https://doi.org/10.2174/1876821001103010026
https://doi.org/10.2174/1876821001103010026
Publikováno v:
Drug Information Journal. 44:727-740
One of the major goals of managing the medication of any clinical trial is to ensure that it is distributed effectively. The continued and increasing use of interactive voice response systems (IVRS) in the management of medication has no doubt result
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0a12e581af88f707dd603483b6c223c9
https://doi.org/10.1177/009286151004400609
https://doi.org/10.1177/009286151004400609
Publikováno v:
Statistics in Medicine. 28:3329-3346
Minimization is a dynamic randomization technique that has been widely used in clinical trials for achieving a balance of prognostic factors across treatment groups, but most often it has been used in the setting of equal treatment allocations. Altho
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b7821c107141120db9f9dc5c7416423
https://doi.org/10.1002/sim.3710
https://doi.org/10.1002/sim.3710
Publikováno v:
Contemporary Clinical Trials
Objective: Non-compliance in clinical studies is a significant issue, but causes remain unclear. Utilizing the Elaboration Likelihood Model of persuasion, this study assessed the psychophysical peripheral cue ‘Interactive Voice Response System (IVR
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fd446eac32776722c19b153d779ab355
https://doi.org/10.1016/j.cct.2008.08.005
https://doi.org/10.1016/j.cct.2008.08.005
Autor:
Damian McEntegart
Publikováno v:
Drug Information Journal. 37:293-308
Many pharmaceutical industry trials seek to achieve a balanced allocation of treatments over prognostic factors, including center. Much of the literature has discussed the merits of this from the viewpoint of statistical efficiency. This motivation i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::21da2964469ac520dce5c08cc695d5c4
https://doi.org/10.1177/009286150303700305
https://doi.org/10.1177/009286150303700305
Publikováno v:
Drug Information Journal. 36:115-125
The detection of fraud and other systematic data irregularities in clinical trials is an important issue. While awareness of the problem is growing and willingness to combat it is clear, there still appears to be a lack of detection procedures suitab
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::70dddafdc83c08b66f6b358a23e3f039
https://doi.org/10.1177/009286150203600115
https://doi.org/10.1177/009286150203600115
Autor:
Damian McEntegart
Publikováno v:
Drug Information Journal. 34:495-499
New Drug Applications require the formation of an integrated safety summary as part of the license submission. The objective of this summary is to identify important serious adverse events and to characterize more common, nonserious adverse events. T
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d818a45aa8af0cef605a20d440acdfa5
https://doi.org/10.1177/009286150003400218
https://doi.org/10.1177/009286150003400218
Publikováno v:
Drug Information Journal. 33:101-107
It is common practice in the pharmaceutical industry to perform checks of the computer database for a clinical study against the data on the case record forms. This check generally encompasses primary efficacy variables which are also the subject of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4c8f51dc1edc10a1443a34761ff06662
https://doi.org/10.1177/009286159903300113
https://doi.org/10.1177/009286159903300113