On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Monday, July 24, 2023
Win Ratio and its application in clinical trials
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The win ratio is a method for examining composite endpoints in clinical trials. It was introduced in 2012 by Dr Pocock and has since been ...
Friday, July 07, 2023
GCP violation and tampering with evidence
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Last week, biotech company BioXcel reported positive efficacy results of their investigational product Igalmi in the treatment of Alzheimer...
1 comment:
Monday, June 26, 2023
Placebo Effect versus Nocebo Effect
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In placebo-controlled clinical trials, a placebo refers to an inactive or inert substance or treatment that has no specific therapeutic effe...
Wednesday, June 21, 2023
SAE reporting - from non-serious AE to serious AE - one event or two events?
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An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious (therefore se...
1 comment:
Saturday, June 17, 2023
Regulatory Education for Industry (REdI) Annual Conference 2023 - Slides and Recordings
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Early this month, FDA conducted 'Regulatory Education for Industry (REdl) Annual Conference 2023'. This annual conference provided ...
Friday, June 02, 2023
Resubmission of NDA/BLA After CRL: Class 1 versus Class 2 resubmission
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If new drug application (NDA) or biological license application (BLA) is not approved by the FDA, the sponsor will receive a complete respon...
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