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...
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...
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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FDA Has Just Released Its Draft Guidance for Industry "Multiple Endpoints in Clinical Trials"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For those who are interested in the design and analysis of clinical trials, FDA has just released its long-anticipated draft guidance for i...