With patients taking more of an active role in their healthcare choices, cost pressures from payers, and the FDA mandate to consider the perspectives of patients during regulatory discussions, it's more important than ever for drug companies to know more than if a medication is safe and effective. They need to know how it makes their patients feel.
In a recent study published in Contemporary Clinical Trials, researchers including Ari Gnanasakthy, MBA, MSc, Head of Patient-Reported Outcomes, looked at the proportion of clinical trials using at least one Patient-Reported Outcome measure (PROM) in the ClinicalTrials.gov database from November 2007 to December 2013. The study showed an increase in the number of trials (27% compared to 14% in earlier estimates) that used a PRO measured uring that timeframe.
The study authors conluded that with initiatives such as the Patient-Focused Drug Development and FDA PRO Guidance, the trend in the use of PRO measures in clinical research will likely increase further. Read more about the research.
Ari Gnanasakthy Talks about Maximizing the Value of PROs in Your Clinical Trials
During his presentation at the 2015 eCOA Forum, Ari Gnanasakthy details opportunities and challenges in choosing, administering and claiming PROs in clinical trials.