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 , , | Comments Off

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 , , , , , , , , , , | 1 Comment

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 Introduction In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs … Continue reading

Posted in FDA, Guest Posts | Tagged , , , , , , , , , , , , , , , | 1 Comment

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 , , , , , , , , | 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 , , , , , | Comments Off