Saturday, September 24, 2016

The first drug approval by FDA for treating Duchenne Muscular Dystrophy (DMD) - who win, who lose?

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Early this year, I wrote an article about “ Race for the first drug approval by FDA for treating Duchenne Muscular Dystrophy (DMD) ”, now c...
Tuesday, September 13, 2016

Free FDA Information Repository

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To learn and understand the regulations in drug development and clinical trials, the documents from FDA’s website are extremely helpful. L...
Friday, September 02, 2016

Dealing with encoding issue in clinical trial data: WLATIN1 and UTF-8

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Nowadays, the clinical trials go to global and are usually multinational. The data collection also goes to the electronic data capture (EDC...
3 comments:
Monday, August 01, 2016

Should hypothesis tests be performed and p-values be provided for safety variables in efficacy evaluation clinical trials?

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p-value is t he probability of observing a test statistic at least as large as the one calculated assuming the null hypothesis is true. In ...
1 comment:
Friday, July 15, 2016

Protocol amendment in clinical trials

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For every clinical trial, study protocol is the centerpiece and study protocol dictates how the study should be conducted, what data will b...
1 comment:
Tuesday, July 05, 2016

Some Blinding Techniques in Clinical Trials

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In randomized controlled clinical trials, the blinding is one of the key components. The purpose of the blinding to the treatment assignmen...