Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Jan 2010
Comment ReviewBiomarker qualification via public-private partnerships.
Biomarkers linked to patient outcomes (safety and efficacy) have an increasingly important role in drug development. Consequently, validation and qualification of such biomarkers are essential, often requiring large data sets from well-controlled randomized clinical trials. In the December 2009 issue of Clinical Pharmacology & Therapeutics, investigators utilizing data from four pharmaceutical companies and working under the auspices of the Biomarkers Consortium described the utility of adiponectin as an early predictor of glycemic control in diabetic patients taking peroxisome proliferator-activated receptor (PPAR) agonists. This work illustrates the advantages of large public-private partnerships for biomarker qualification.
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Clin. Pharmacol. Ther. · Jan 2010
Comparative StudyComparison of critical drug-drug interaction listings: the Department of Veterans Affairs medical system and standard reference compendia.
The objective of this study was to evaluate the agreement among the US Department of Veterans Affairs (VA) listing of "critical" drug-drug interactions (DDIs) and two standard drug-interaction compendia. A list of critical DDIs, as defined by the VA, was compared with two standard commercially available compendia (Micromedex DRUG-REAX and Drug Interactions: Analysis and Management (DIAM)) in order to determine the level of agreement among the systems. Of 982 DDIs classified as critical by the VA, only 136 DDIs (13.7%) were considered critical in all three systems. Our conclusion was that, overall, there is poor agreement among the compendia and the VA system.