Monday, October 26, 2020

Real World Evidence in Regulatory Submissions - Story of IBRANCE for male breast cancer

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In April 2019, FDA approved Pfizer's IBRANCE for male breast cancer . The approval is for the label extension for an already produce bas...
Friday, October 23, 2020

Randomly Select a Subset from a Population Using SAS Proc Surveyselect and Dividing a Population into Multiple Subsets Using SAS Proc Rank

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During a clinical trial, sometimes, we are asked to select a subset of subjects from all trial participants. For example, for a clinical tri...
Sunday, October 18, 2020

Visual Inspection and Statistical Tests for Proportional Hazard Assumption

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To analyze the time to event data (or survival analysis in the early days), the most commonly used approaches are the non-parametric method ...
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Thursday, October 15, 2020

The fate of confirmatory clinical trials for Remdesivir for treatment of COVID-19

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Remdesivir, as the first highly touted drug to treat COVID-19 patients, has now been approved for emergency use authorization in several cou...
Monday, October 12, 2020

Randomized Controlled Trial in Sheep and Methodological Rigor in Preclinical Studies

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Miller et al published a paper in blue journal (AJRCCM) " Combined Mesenchymal Stromal Cell Therapy and Extracorporeal Membrane Oxygena...
Tuesday, October 06, 2020

Covid-19 Vaccine: Is 50% Vaccine Efficacy (VE) Too Low?

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Ever since FDA issued its guidance “ Development and Licensure of Vaccines to Prevent COVID-19 ,” to help facilitate timely development of s...
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Saturday, October 03, 2020

Should We Follow ICH E9 Addendum to Include the Estimands in all Clinical Trial Protocols?

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ICH E9 " Statistical Principles for Clinical Trials " was issued in 1998 - more than 20 years ago. While the principles specified ...