Multi-site retropspective study
On Friday June 26, 2009 multiple research reports and an editorial were posted on the Diabetologia web-site addressing the possibility of a relation between insulin glargine and cancer. Though the conclusions of the studies were heterogeneous, quite a global stir ensued among healthcare providers, patients, regulatory authorities, and the pharmaceutical industry. Within days, Sanofi began to work with multiple investigators in the United States and Europe to conduct a broad set of large-scale, high quality pharmacoepidemiology studies. Since then, primary research reports, consensus conferences, editorials and meta-analyses have continued to address this issue with conflicting results and opinions. Within this web site, we report the general design and analysis plans for four collaborating studies to address the issue of glargine and cancer. Through this collaboration, efforts have been made to align definitions of exposure and incident cancers.