Sunday, September 20, 2020

Should Clinical Trial Protocol be Made Public While the Trial is still ongoing?

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Drug companies are under pressure for more and more transparency in clinical trials. It has been a common practice now to post the clinical ...
1 comment:
Wednesday, September 09, 2020

WHO - Draft landscape of COVID-19 candidate vaccines - tracking COVID-19 vaccines

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World Health Organization keeps tracking the progress of the vaccine candidates against COVID-19 and just published a report called " d...
2 comments:
Tuesday, September 01, 2020

Finkelstein-Schoenfeld Method, Win Ratio, and Hodges-Lehman Estimates - Statistical Methods Based on All Paired Comparisons

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Finkelstein-Schoenfeld methods can be used in analyzing the data with a  composite endpoint where different components for the composite en...
6 comments:
Thursday, August 27, 2020

How to interpret the risk ratio? - A controversy related to FDA's EUA announcement of convalescent plasma in treatment of Covid-19

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This past Sunday, FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievem...
2 comments:
Sunday, August 23, 2020

Participants, Patients, Subjects, Volunteers, What to Use?

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For people who participate in clinical trials, what should we call them? Subject, volunteer (healthy volunteer), participant, or patient? Th...
1 comment:
Monday, August 17, 2020

Unit of Analysis in Clinical Trials

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The Unit of Analysis is the entity that frames what is being analyzed in a study or clinical trial. It is the entity being studied as a whol...
1 comment:
Monday, August 03, 2020

Time to Event Data: What to Present? Hazard Ratio, Median Time, Survival Rate?

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One of the common endpoints in clinical trials is time to event as calculated as the duration from the time of randomization to the time of ...
1 comment:
Sunday, July 26, 2020

Blinding and Masking Issue in Covid-19 Vaccine Clinical Trials

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Clinical trials for Covid-19 vaccine development are moving into the critical late phase stage. The front runners right now are Moderna (in ...
7 comments: