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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

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

Survival Analysis in Medical Research and Bayesian Methods

Statistical Consultancy Team

We are pleased to confirm that Quanticate will have a speaker at the 2011 European Statistical Forum (ESF) Conference. Entitled “Bayesian Study Design for Survival Endpoints: Enhancing decision making in early clinical development”, the talk will focus on Phase II, or ‘Proof of Concept’ studies.

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Topics: Bayesian Statistics, Bayesian Study Design, European Statistical Forum, Bayesian Methods, Survival Analysis

Biomarkers in Drug Development

Statistical Consultancy Team

The identification of novel and effective biomarkers in drug development is considered a key feature in the optimization of the drug development process. But what exactly is a biomarker? As defined by Grutolla et al. [1], a biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Examples include concentrations of particular proteins in the blood or bone marrow, liver function tests or PET imaging as indicators of disease state or therapeutic benefit.

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Topics: Bayesian Study Design, Phase I Studies, Biomarkers, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design, Drug Development

Adaptive Design and Bayesian Methods – Controlling Time and Cost

Statistical Consultancy Team

When planning a clinical study there are considerable financial benefits to seeking out the latest available scientific knowledge and most appropriate statistical approaches to study design. Over the years many adaptive design and Bayesian methodologies have become widely used, but choosing the right ones at the right time is crucial to placing control over research programmes at all stages of development. Well planned study designs ensure the best project go/no go decisions and lead to the earliest possible technical and regulatory success.

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

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

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