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Tag Archives: statistical analysis
Five Keys to Successful Adaptive Trials
This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. Running adaptive trials is not easy. However, in a world of skyrocketing drug development costs, these trials are … Continue reading
Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective
Image via Wikipedia This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. The Joint Statistical Meetings is often a good place to learn about emerging issues in the … Continue reading
Statistical Implications of Protocol Amendments
This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. Clinical trial protocol amendments occur for good reasons. An unanticipated safety issue may arise, new information about the … Continue reading
Posted in Clinical Trials, Guest Posts, Statistics
Tagged clinical trials, protocol, statistical analysis
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New Draft Guidance on Noninferiority Trials
In March 2010, the FDA issued a draft guidance on the use of noninferiority (NI) trials. While not in final form, this guidance should help sponsors understand the issues the FDA considers when reviewing NI trials. In contrast to statements … Continue reading
Posted in FDA, Guest Posts
Tagged clinical trials, efficacy, FDA, guidance, noninferiority trials, statistical analysis
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When Should You Write your Statistical Analysis Plans?
This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical … Continue reading
Posted in Clinical Trials, Guest Posts, Statistics
Tagged biostatistics, case report form, CRF, enrollment, FDA, LinkedIn, methodology, Phase 3, protocol, SAP, statistical analysis
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