Clinicaltrials.gov Database Reveals “Sausage Making” in Clinical Research

JAMA: 9/10/13

With more than 150 000 clinical trials now registered, clinicaltrials.gov, the database created to increase transparency in clinical research, is providing some unflattering insights, according to research findings reported at the Seventh International Congress on Peer Review and Biomedical Publication in Chicago this week.

No one anticipated the role of clinicaltrials.gov “as a window into the sausage factory,” said Deborah Zarin, MD, director of clinicaltrials.gov, which is run by the US National Library of Medicine (NLM) at the National Institutes of Health.

The database, which began including a summary of study results in 2009, was intended to increase access to data from clinical trials of medical interventions, to reduce selective publication of results to make an intervention look more effective, and to hold researchers more accountable. According to Zarin, the effort has made it possible to probe how closely scientists are following their protocols and to assess the reliability of results reported in the clinical literature—research that was impossible to carry out before the advent of the database. Read More