Friday, April 28, 2017

CURRENT ISSUES REGARDING DATA AND SAFETY MONITORING COMMITTEES IN CLINICAL TRIALS

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Last week, I attended the 10th Annual Conference on Statistical Issues in Clinical Trials held in the camps of the University of Pennsylvani...
Friday, April 07, 2017

Estimate the number of subjects needed to detect at least one event and the rule of three

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It is sometimes important to know how likely a study is to detect a relatively uncommon event, particularly if that event is severe, such a...
Wednesday, March 22, 2017

Regenerative (Medicine) Advanced Therapy: from RAT to ART to RMAT

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In the United States, the government can promote or incentivize the drug development in certain areas through its policies. In FDA, there a...
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Monday, March 20, 2017

Minimization Algorithm to Achieve Treatment Balance across Strata in Stratified Randomization

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In randomized controlled clinical trials, we usually need to consider if there are any prognostic factors that may have influence on the pr...
Thursday, March 16, 2017

Block size in randomization and generating the randomization with variable block size

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In clinical trials, the most popular randomization approach is probably the randomized block design. With a  randomized block design, study...
Sunday, March 05, 2017

Inclusion/exclusion violations, protocol deviations, protocol deviation waiver, rescreening, and others

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In one of my previous posts, I discussed " Protocol Deviation versus Protocol Violation and its Classifications (minor, major, critica...
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Tuesday, February 21, 2017

Constructing stopping rule for safety monitoring

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In many early phase clinical trials, if there is a known risk or theoretically potential risk for patients' safety, it is very common th...