An evaluation of the trimmed mean approach in clinical trials with dropout
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - April 6, 2018 Category: Statistics Authors: Ming ‐DauhWang
,
JiajunLiu
,
GeertMolenberghs
,
CraigMallinckrodt Source Type: research
Better decision making in drug development through adoption of formal prior elicitation
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - March 30, 2018 Category: Statistics Source Type: research
Issue Information
Pharmaceutical Statistics,Volume 17, Issue 2, Page 91-93, March/April 2018. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - March 28, 2018 Category: Statistics Source Type: research
Bayesian approach for assessing noninferiority in a three ‐arm trial with binary endpoint
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - February 22, 2018 Category: Statistics Source Type: research
Bayesian joint modelling of benefit and risk in drug development
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - February 22, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics, Ahead of Print. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - February 22, 2018 Category: Statistics Source Type: research
Bayesian joint modelling of benefit and risk in drug development
To gain regulatory approval, a new medicine must demonstrate that its benefits outweigh any potential risks, ie, that the benefit‐risk balance is favourable towards the new medicine. For transparency and clarity of the decision, a structured and consistent approach to benefit‐risk assessment that quantifies uncertainties and accounts for underlying dependencies is desirable. This paper proposes two approaches to benefit‐risk evaluation, both based on the idea of joint modelling of mixed outcomes that are potentially dependent at the subject level. Using Bayesian inference, the two approaches offer interpretability an...
Source: Pharmaceutical Statistics - February 22, 2018 Category: Statistics Authors: Maria J. Costa, Thomas Drury Tags: MAIN PAPER Source Type: research
Bayesian statistical models to estimate EQ ‐5D utility scores from EORTC QLQ data in myeloma
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - February 20, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics, Ahead of Print. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - February 20, 2018 Category: Statistics Source Type: research
Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters
Pharmaceutical Statistics, EarlyView. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - February 8, 2018 Category: Statistics Source Type: research
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Pharmaceutical Statistics, Ahead of Print. (Source: Pharmaceutical Statistics)
Source: Pharmaceutical Statistics - February 8, 2018 Category: Statistics Source Type: research
Bayesian approach for assessing noninferiority in a three ‐arm trial with binary endpoint
With the recent advancement in many therapeutic areas, quest for better and enhanced treatment options is ever increasing. While the “efficacy” metric plays the most important role in this development, emphasis on other important clinical factors such as less intensive side effects, lower toxicity, ease of delivery, and other less debilitating factors may result in the selection of treatment options, which may not beat current established treatment option in terms efficacy, yet prove to be desirable for subgroups of patients. The resultant clinical trial by means of which one establishes such slightly less efficacious ...
Source: Pharmaceutical Statistics - February 1, 2018 Category: Statistics Authors: Santu Ghosh, Ram C. Tiwari, Samiran Ghosh Tags: SPECIAL ISSUE PAPER Source Type: research
Bayesian statistical models to estimate EQ ‐5D utility scores from EORTC QLQ data in myeloma
The objective of this study is to develop a series of two‐part models (TPMs) that deal with these issues. Data from the UK Medical Research Council Myeloma IX trial were used to examine the relationship between the European Organization for Research and Treatment of Cancer (EORTC) QLQ‐C30/QLQ‐MY20 scores and the European QoL‐5 Dimensions (EQ‐5D) utility score. Four different TPMs were developed. The models fitted included TPM with normal regression, TPM with normal regression with variance a function of participant characteristics, TPM with log‐transformed data, and TPM with gamma regression and a log link. The...
Source: Pharmaceutical Statistics - February 1, 2018 Category: Statistics Authors: Samer A. Kharroubi, Richard Edlin, David Meads, Christopher McCabe Tags: SPECIAL ISSUE PAPER Source Type: research
Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters
Patients, physicians, and health care providers in Europe have more than 10 years of experience with biosimilars. However, there are still debates if switching between a biosimilar and its reference product influences the efficacy of the treatment. In this paper, we address this uncertainty by developing a formal statistical test that can be used for showing that switching has no negative impact on the efficacy of biosimilars. For that, we first introduce a linear mixed‐effects model that is used for defining the null hypothesis (switching influences the efficacy) and the alternative hypothesis (switching has no influe...
Source: Pharmaceutical Statistics - February 1, 2018 Category: Statistics Authors: Johanna Mielke, Heike Woehling, Byron Jones Tags: MAIN PAPER Source Type: research
