Secrets of trial data revealed

摘要

Drug companies, regulatory bodies and research groups are in a deadlock over plans to throw open the vaults of sensitive data gleaned from clinical trials. But just as the battle seems to be coming to a head, a study (B. Wieseler et al. PLoS Medicine 10, el001526; 2013) has revealed exactly why the restricted information could be so valuable to researchers. According to the analysis, crucial trial information, such as mortality rates and serious side effects, is missing from much published data. But it can frequently be found in standard non-public documents prepared by industry, known as clinical study reports (CSRs). Missing information uncovered by the study includes details of depression symptoms in trials for antidepressant drugs, and details of heart attacks and strokes in diabetes-drug trials. "These are very, very important variables and outcomes," says the study's lead author, Beate Wieseler, head of the drug-assessment department at the Institute for Quality and Efficiency in Health Care in Cologne, Germany.