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Tag Archives: protocol
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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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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Analysis of FDA Guidance on Adaptive Designs
This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. 1. Introduction In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs … Continue reading
Regulatory Affairs Workload Increasing
I would rather have a big burden and a strong back, than a weak back and a caddy to carry life’s luggage – Elbert Hubbard I don’t know if you follow the Tufts Center for the Study of Drug Development … Continue reading
Posted in Industry News
Tagged clinical research, clinical trials, contract employees, NDA, outsourcing, protocol, regulatory affairs, strategic insourcing, Tufts
1 Comment
Tips for your Special Protocol Assessment
A number of scientists with greatly different backgrounds can come up with completely different assessments. – Richard Leakey One question that we hear frequently is: Can we apply for a Special Protocol Assessment (SPA) for our Phase 3 trial? The … Continue reading
Posted in FDA
Tagged advisory committees, FDA, guidance, Phase 3, protocol, special protocol assesment
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