Healthy subjects volunteering for Phase I studies: Influence of curiosity, exploratory tendencies and perceived self-efficacy

2008 ◽  
Vol 46 (03) ◽  
pp. 109-118 ◽  
Author(s):  
L. Almeida ◽  
T.B. Kashdan ◽  
R. Coelho ◽  
A. Albino-Teixeira ◽  
P. Soares-da-Silva
Keyword(s):  
Phase I ◽  
Self Efficacy ◽  
Healthy Subjects ◽  
Phase I Studies

scholarly journals The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Georg Ferber ◽  
Ulrike Lorch ◽  
Jörg Täubel
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Sparse Sampling ◽  
Positive Control ◽  
Qtc Prolongation ◽  
False Negatives ◽  
Assay Sensitivity ◽  
Phase I Studies ◽  
Sufficient Power

Concentration-effect (CE) models applied to early clinical QT data from healthy subjects are described in the latest E14 Q&A document as promising analysis to characterise QTc prolongation. The challenges faced if one attempts to replace a TQT study by thorough ECG assessments in Phase I based on CE models are the assurance to obtain sufficient power and the establishment of a substitute for the positive control to show assay sensitivity providing protection against false negatives. To demonstrate that CE models in small studies can reliably predict the absence of an effect on QTc, we investigated the role of some key design features in the power of the analysis. Specifically, the form of the CE model, inclusion of subjects on placebo, and sparse sampling on the performance and power of this analysis were investigated. In this study, the simulations conducted by subsampling subjects from 3 different TQT studies showed that CE model with a treatment effect can be used to exclude small QTc effects. The number of placebo subjects was also shown to increase the power to detect an inactive drug preventing false positives while an effect can be underestimated if time points aroundtmaxare missed.

scholarly journals Normal Range of Rapid ACTH Test for Healthy Subjects in Phase I Studies.

2000 ◽  
Vol 31 (4) ◽  
pp. 557-563
Author(s):  
Katsutoshi OGAWA ◽  
Kayoko HASHIMOTO ◽  
Osamu MATSUOKA ◽  
Hisakuni SEKINO ◽  
Satoshi KAMATA ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Acth Test ◽  
Normal Range ◽  
Phase I Studies

Why healthy subjects volunteer for phase I studies and how they perceive their participation?

2007 ◽  
Vol 63 (11) ◽  
pp. 1085-1094 ◽  
Author(s):  
Luis Almeida ◽  
Benedita Azevedo ◽  
Teresa Nunes ◽  
Manuel Vaz-da-Silva ◽  
Patrício Soares-da-Silva
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Phase I Studies

Pharmacokinetics of Vandetanib: Three Phase I Studies in Healthy Subjects

2012 ◽  
Vol 34 (1) ◽  
pp. 221-237 ◽  
Author(s):  
Paul Martin ◽  
Stuart Oliver ◽  
Sarah-Jane Kennedy ◽  
Elizabeth Partridge ◽  
Michael Hutchison ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Phase I Studies ◽  
Three Phase

scholarly journals Romidepsin and lenalidomide based regimens have efficacy in relapsed/refractory lymphoma: combined analysis of two phase I studies with expansion cohorts

2021 ◽  
Author(s):  
Neha Mehta‐Shah ◽  
Matthew A. Lunning ◽  
Alison J. Moskowitz ◽  
Adam M. Boruchov ◽  
Jia Ruan ◽  
...  
Keyword(s):  
Phase I ◽  
Two Phase ◽  
Phase I Studies ◽  
Combined Analysis ◽  
Refractory Lymphoma
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