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Tag Archives: protocol
Annual Reports: A Time for Reflection
You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year? Quite possibly. In the rush to keep things moving, it’s all too easy to not take the time … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged 21 CFR, adverse events, annual report, clinical trials, CMC, drug development, eCTD, FDA, IND, nonclinical research, protocol
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Statistics and Statisticians in Clinical Trials – Beginning with the End in Mind
Cover of The 7 Habits of Highly Effective People Begin with the end in mind … is imagination–the ability to envision in your mind what you cannot at present see with your eyes. It is based on the principle that all … Continue reading
Posted in Clinical Trials, Statistics
Tagged clinical trials, drug development, efficacy, Electronic data capture, protocol, statistical analysis
1 Comment
Statistical Implications of Protocol Amendments
Clinical trial protocol amendments occur for good reasons. An unanticipated safety issue may arise, new information about the disease or treatment may suggest alterations, or recruitment and enrollment may not go as planned. One aspect of protocol amendments that often … Continue reading
Posted in Clinical Trials, Statistics
Tagged clinical trials, protocol, statistical analysis
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When Should You Write your Statistical Analysis Plans?
Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of … Continue reading
Posted in Clinical Trials, Statistics
Tagged biostatistics, case report form, CRF, enrollment, FDA, LinkedIn, methodology, Phase 3, protocol, SAP, statistical analysis
1 Comment
Analysis of FDA Guidance on Adaptive Designs
In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s … Continue reading
