Despite rising interest in real world outcomes, our recent study (a collaboration with Pfizer) demonstrates that less than ten percent of diabetes clinical trials conducted in the past decade included patient-reported outcomes (PROs) as part of their protocols. We are presenting today at the 18th annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) conference in New Orleans. The study analyzed nearly 650 Phase 3 and Phase 2/3 diabetes clinical trials from the clinicaltrials.gov database. Among these trials, only 7.4 percent (47 trials) included PROs as part of their assessment protocols.
"One of the current trends in the pharmaceutical industry is to track real world outcomes. However, in the area of diabetes, one of the most prevalent diseases in the United States, patient-reported outcomes, which are a commonly used real world assessment tool, were included in less than ten percent of clinical trial protocols since the year 2000," said Ashley Jaksa, MPH, director of data and analytics at Context Matters.
The study concluded that the development of a standardized clinical trial-specific tool that helps measure patient-reported outcomes might lead to wider incorporation of PROs in clinical trial protocols, in line with the interest in real world outcomes.
"Working with Context Matters has been a very valuable experience. In the past, it was difficult and time-consuming to collect this information, but their data curation procedures and analytics platform has allowed us to gain a quick, clear understanding of the use of PROs in diabetes clinical trials in the past decade, " Alexandra Barsdorf, associate director, PRO Centre of Excellence, Global Market Access, PCBU, Pfizer, Inc.