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...
Sunday, February 12, 2017

Can drug be approved without demonstrating efficacy?

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Pharmaceutical industry is assessing the impact of the Trump administration on regulations in drug approval and drug price. It looks like t...
1 comment:
Friday, January 20, 2017

the 21st Century Cures Act: Key Provisions

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Last week and this week,  Hyman, Phelps &McNamara, P.C. gave two excellent webinars to explain the key provisions from the 21st Centur...
Thursday, January 12, 2017

FDA Has Just Released Its Draft Guidance for Industry "Multiple Endpoints in Clinical Trials"

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For those who are interested in the design and analysis of clinical trials, FDA has just released its long-anticipated draft guidance for i...
Saturday, January 07, 2017

Exclusion of pregnant women from clinical trial and pregnancy test for women of childbearing potential (WOCBP)

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Even though it is encouraged for clinical trials to include the women subjects , the clinical trial protocols commonly (almost always) conta...
10 comments:
Thursday, December 22, 2016

Control for Type I Error (or Adjustment for Multiplicity) for Secondary Endpoints

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In clinical trial protocols, we usually specify one or more primary efficacy endpoints, then a list of secondary efficacy endpoints, and th...
4 comments:
Tuesday, December 20, 2016

the 21st Century Cures Act and Innovations in Clinical Trials

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After the bill passed through house and senator, the president Obama signed the bill into law on December 13, 2016. The 21st Century Cures A...
Sunday, December 11, 2016

Commonly Used Procedure for Multiplicity Adjustment: Fixed Sequence Procedure, Holm Step-down Procedure, Hochberg Step-up Procedure

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In clinical trials, we often have the multiple tests or multiplicity issue when there are more than one hypothesis tests built in the same ...