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7 Frequently asked Questions on Clinical Study Design

Statistical Consultancy Team

Quanticate has released several white papers around Clinical Study Design in the area of Bayesian Statistics and a focus on Phase 1 studies. Our statistical consultancy team was pleased to receive feedback and questions from our clients and piers on these papers which we would like to share with you all below.

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Topics: Bayesian Statistics, Bayesian Study Design, Bayesian Methods, Phase I Studies, Clinical Study Design, Interim Analysis, Biostatistics Consulting, Phase I Study Design

Complex Randomization in Clinical Trials Need Not Be Complex

Statistical Consultancy Team

 

Whilst delivering statistical consultancy to one of our clients, we designed a clincial trial with five treatment arms: three were various doses of the active compound, one arm was a positive control and the final arm was a negative control.

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Topics: Statistical Programming, Clinical Study Design, Interim Analysis, Randomization

Bayesian Methods and a review of the European Statistical Forum

Statistical Consultancy Team

A member of Quanticate's Statistical Consultancy Team writes about their attentedence and presentation at the European Statistical Forum, Milan Nov, 2011.

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Topics: Regulatory Requirements, Bayesian Statistics, Bayesian Study Design, European Statistical Forum, Bayesian Methods, Survival Analysis, Interim Analysis, Biostatistics Consulting, Clinical Trial Phases

Bayesian Study Design & Interim Analysis In Clinical Trials

Statistical Consultancy Team

Interim analyses are widely used in clinical trials. They offer companies the opportunity to stop studies early in cases where it looks as if the primary objective will not be achieved (often referred to as ‘stopping for futility’).

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Topics: Bayesian Statistics, Bayesian Study Design, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Adaptive Trial Design

An Introduction To Biostatistics In Clinical Trials

Statistical Consultancy Team

 

A biostatistician is not just a number-crunching individual providing a p-value, making sense of data and identifying whether treatment A worked better than treatment B. Biostatisticians in clinical research are typically integral members of project teams providing advice throughout the entire compound development process, offering far more than a service just to be dipped in and out of whenever numbers crop up.

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Topics: Bayesian Statistics, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Adaptive Trial Design

Economical Designs for Phase I Studies

Statistical Consultancy Team
The objectives of the Phase I development plan are many. Alongside establishing the safety, tolerability and pharmacokinetics (PK) of single and multiple doses in humans and ascertaining the maximum tolerated dose, it is often important to explore at least some of the following:
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Topics: Statistical Programming, Pharmacokinetics and Pharmacodynamic, Phase I Studies, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design

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