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Tag Archives: efficacy
Improving Assessment Data Consistency in Multi-Center Studies
Ensuring assessments are conducted, analyzed, and reported consistently across sites is a challenge facing managers of multi-center clinical studies. While identification and quantification of between site variation is typically part of the statistical analysis, collecting more consistent data from the … Continue reading
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
Accelerated Approval
Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics: … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged accelerated approval, clinical benefit, DDMAC, efficacy, FDA, postmarketing, safety, surrogate endpoint
1 Comment
505(b)(2) Marketing Applications – Bridging the Gaps
There is no doubt that the drug development business is very expensive and development can take many years before a viable, money-generating product can be marketed. A strategy some of our clients implement to more quickly and more inexpensively develop … Continue reading
Posted in FDA, Regulatory Strategy
Tagged 505(b)(2), bioequivalence, drug development, efficacy, FDA, novel therapeutic, pivotal studies, route of administration, safety
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New Draft Guidance on Noninferiority Trials
In March 2010, the FDA issued a draft guidance on the use of noninferiority (NI) trials.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
Tagged clinical trials, efficacy, FDA, guidance, noninferiority trials, statistical analysis
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