Biomarker 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.
Eck
S L
SL
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
Paul
S M
SM
D052242:Adiponectin / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D004345:Drug Industry / Q000379:methods / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism; D055818:Public-Private Sector Partnerships / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000379:methods
D052242:Adiponectin; D015415:Biomarkers; D001786:Blood Glucose; D004364:Pharmaceutical Preparations