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Overview of Receiver Operating Characteristic (ROC) Curves in SAS

Statistical Consultancy Team

The repeated dosing of some drugs can induce injury to the human liver. Regular monitoring of biomarkers assayed in blood samples may help to diagnose safety issues sooner. There is interest in developing new biomarkers that are more specific than the standard tests [e.g. Alanine Transaminase (ALT)] commonly used. 

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Topics: Statistical Programming, SAS Programming, Biomarkers, ROC Analysis, ROC Curve

CDISC SDTM Therapeutic Area Domains - a Rapidly Evolving Standard?

Clinical Programming Team

The CDISC SDTM model is considered the most stable of the CDISC standards: version 3.1.1 of the Implementation Guide (IG) was published in August 2005; 3.1.2 in November 2008 which has remained the accepted standard. However, in this year’s European Interchange, CDISC revealed an aggressive timeline of therapeutic area (TA) SDTM domain development. From slides 17 and 18 of the presentation you can see that 14 new TA domains are intended to be developed in 2012 alone. The overall goal is to standardise efficacy data elements from 57 TAs in 7 years.

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Topics: CDISC SDTM, SDTM Domains, CDISC, Standardization, Clinical Programming, Biomarkers, SDTM, CDISC Standards, Therapeutic Areas

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

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