A new section of the NIH Pragmatic Trials Collaboratory’s Living Textbook of Pragmatic Clinical Trials discusses challenges associated with Evaluating Fitness for Use of real-world data for trials. The section uses a case study from the Harmony Outcomes EHR Ancillary Study (eHARMONY) to describe lessons learned and to provide recommendations for studies considering incorporating real-word data as a data source.

Among the lessons learned were:

• Standalone clinical research sites had very little extractable EHR data about patients.
• Most lab results and medications were either not extractable or not mapped to a useful terminology.
• Many sites did not have the ability to transform their data into a common format and had to send rudimentary data extracts to the ancillary study coordinating center. Sites participating in other research networks, such as PCORnet, had no difficulty with this task.

For more, read the chapter or watch the Grand Rounds presentation Leveraging RWD in a Multinational Trial: Results from the other eHARMONY