Thursday, November 8, 2012

Are Pharma Companies increasing the number of Voluntarily initiated Phase IV trials

The study, “Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management,” conducted by Cutting Edge Information found that 82% of surveyed companies’ post-marketing trials are voluntarily initiated. That percentage is an increase from 61% of Phase IV trials that were voluntarily initiated by drug manufacturers in 2006.

I took a quick look at the number of phase IV trials at the ClinicalTrials.gov registry and surprised to see that the number of Phase IV trials disclosed by Pharmaceutical companies was on a decline. Is the disclosure limited to trials that are conducted as part of Life Cycle Managment of the drugs or are the companies conducting trials purely for commercial reasons and do not have an obligation to report those.

Here is what ClinicalTrials.gov reflects on the phase IV trials run by pharmaceutical companies.