FierceBiotechIT recently wrote about our analysis of online data, researched by the team here at Context Matters in collaboration with Pfizer, that found only 7.4% (47 trials) of 650 Phase 3 and Phase 2/3 clinical trials for diabetes treatments included patient-reported outcomes. Despite rising interest in real world outcomes, our team was surprised to see that less than ten percent of diabetes clinical trials conducted in the past decade included PROS as part of their assessment protocols. Our research, presented at the 18th annual ISPOR conference, created much discussion due to its real world assessment of the exclusion of PROS in diabetes clinical trials.
“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.
By using our data and analytics platform, our team, along with Pfizer, proposed a solution to the problem; the advancement of a standardized clinical trial-specific tool that helps measure PROS which might lead to broader integration of patient-reported outcomes in clinical trial protocols.
"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...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.