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Bayesian approaches to use historical data in the analysis of clinical trials

Statistical Consultancy Team

The BAYES 2018 Bayesian Biostatistics workshop took place from the 20th to the 22nd of June, and was an extraordinary chance to discuss how Bayesian methodology can be used within the pharma industry.

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Topics: Bayesian Study Design, Bayesian Methods, Bayesian Statistics, Historical Data, Statistical Consultancy, Statistics, Biostatistics Consulting, Clinical Study Design

[Video] Bayesian Methodology - How to Analyse Multiple Endpoints

Statistical Consultancy Team

In this Statistical Knowledge Share Video our Principal Statisticians, Sonia, presents an example of Bayesian Methodology using simulated data and examines how to analyze Multiple End Points in Clinical Trials.

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Topics: Statistics, Statistical Knowledge Share, Multiple Endpoints, Bayesian Methods, Bayesian Statistics, SAS Programming

Utilizing a Bayesian Informative Prior to Reduce Sample Size in Clinical Trials

Statistical Consultancy Team

Bayesian_Informative_Prior_to_Reduce_Sample_Size_in_Clinical_Trials

Bayesian statistics in clinical trials are becoming more widely used in the pharmaceutical industry. By gathering data from historical studies, it is possible to reduce the sample size of the current trial by using an informative prior in the Bayesian analysis. This blog explores five cases in different indications that have historical data on placebo subjects from the literature, and calculates the effective sample size using an informative prior. In some cases, the effective sample size is substantial, but in others there are no sample size savings despite abundant data in the literature.

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Topics: Bayesian Statistics, Bayesian Methods, Statistical Programming, Biostatistics Consulting

Efficient Data Reviews and Quality in Clinical Trials [Video]

Statistical Consultancy Team

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Topics: Bayesian Statistics, Randomization, Serious Adverse Events (SAEs), Quality Control, CDISC, SAS Programming, Remote Monitoring, On-Site Monitoring, FDA, Visualization, Standardization, Remote Data Capture, Source Data Verification (SDV), Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

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

Using Historical Data to Inform Future Decisions in Clinical Trials

Statistical Consultancy Team

The majority of companies within the Pharmaceutical Industry have large historical clinical databases, much of which may never be used beyond its original purpose: to prove that the drug in question is safe and efficacious. This historical data can be used to better inform future decisions in clinical trials. 

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Topics: Bayesian Statistics, Programming R, Phase I Studies, Adverse Events (AEs), Clinical Study Design, Historical Data

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

Adaptive Clinical Trial 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 clinical study designs. 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

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

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