American College of Rheumatology (ACR) and Food and Drug Administration (FDA) Summit: Summary of the Meeting May 17-18, 2022.

On May 17-18, 2022, the ACR and the FDA co-sponsored a public meeting to address topics of mutual interest and importance in assessing long-term safety and clinical efficacy, as well as novel approaches to clinical trials in rheumatoid arthritis (RA) and psoriatic arthritis (PsA). During the two-day consensus-building summit, rheumatologists, other health care professionals, and FDA staff provided a broad perspective on current clinical development challenges and potential approaches to address them. Key takeaways are summarized in this document, including issues related to innovative clinical trial designs, use of novel outcome measures such as magnetic resonance imaging (MRI) and patient-reported outcomes (PROs), and use of innovative approaches to collecting data including registries and digital health technology (DHT).