Quanticate CRO Blog

How Big is Big Data in Clinical Trials – Tall, Grande, Venti Data?

Posted by Nick Burch on Fri, Aug 29, 2014

 

Today, Big Data is one of the hot topics within almost every Industry, especially in clinical trials. May saw the biggest ever European technologists conference on this, Berlin Buzzwords, while the likes of O'Reilly's Strata conference pull in huge numbers of attendees keen to learn how to adapt to this new world.

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Tags: Clinical Trials, Clinical Data Storage, Clinical Study Design, Medical Device, Big Data

Hitting New Targets - EPC Interview with David Underwood

Posted by David Underwood on Mon, Aug 18, 2014

European Pharmaceutical Contractor held an interview with Quanticate CEO; David Underwood, asking how he started in the pharmaceutical industry, the reasons behind Quanticate's recent success and future trends as well as regulations in the industry.

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Tags: Clinical Trials, Bayesian Methods, CEO's Insight, Visualization, Adaptive Trial Design

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Posted by Statistical Consultancy Team on Fri, Jul 18, 2014

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live 2013.

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Tags: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

Is Multiple Imputation in Clinical Trials Worth the Effort?

Posted by Statistical Consultancy Team on Mon, Jun 30, 2014

In a case study examined to look at Multiple Imputation (MI) in clinical trials, comparing Active to Placebo treatment (at Weeks 2, 4, 6 and 12 of the trial) in adolescents with acne, drop outs were common.  The primary endpoint was the number of lesions at Week 12.  The factors believed to affect the propensity to be missing included age, side effects and lack of efficacy, and thus missing data patterns differ between groups. 

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Tags: Statistical Programming, FDA, SAS Programming, Statisticians in the Pharmaceutical Industry (PSI), Propensity Scoring, Multiple Imputation

Efficient Data Reviews and Quality in Clinical Trials [Video]

Posted by Statistical Consultancy Team on Fri, Jun 13, 2014

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

Preparing for Big Data in Pharma

Posted by Nick Burch on Fri, May 23, 2014


 

Today, the Pharmaceutical industry, like many, has its feet in both camps when it comes to Big Data. Some parts of the industry, such as genomics and drug discovery, were early adopters and today couldn't imagine life without Big Data technologies and approaches. Others are pushing their current approaches to near their limits, and are beginning to consider "what's next?"

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Tags: Clinical Data Storage, Large Datasets, Big Data

Prentice-Wilcoxon Test for Paired Time-to-Event Data

Posted by Statistical Consultancy Team on Fri, May 16, 2014

In survival analyses we conventionally compare a time-to-event endpoint between two or more strata; patients are either represented in one strata or the other and the strata are independent of each other.
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Tags: Survival Analysis, Statistical Programming, Statisticians in the Pharmaceutical Industry (PSI), SAS Macros, Prentice Wilcoxon Test

7 Frequently asked Questions on Clinical Study Design

Posted by Statistical Consultancy Team on Fri, Jan 31, 2014

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

Longitudinal Observational Data in a Paediatric Disease Registry

Posted by Statistical Consultancy Team on Tue, Jan 21, 2014

The use of population-based disease registries to support ongoing data collection for long-term safety and clinical outcomes is becoming increasingly common. Data collection methods within registries can vary in terms of completeness and quality. This particular example arose from support to a post-registration commitment for marketing authorisation of a paediatric drug and aims to provide some insight to the techniques and strategies used to monitor paediatric development (growth, sexual maturation) and clinical outcomes of varying severity. The challenges of accounting for irregular follow-up and associated biases are illustrated, and potential statistical solutions described. Recommendations for future reporting are presented as part of the conclusions. 

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Tags: Statistical Programming, Randomization, Paediatric Disease Registry

Using Historical Data to Inform Future Decisions in Clinical Trials

Posted by Statistical Consultancy Team on Fri, Nov 15, 2013

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