The FDA encourages collection and reporting of patient-reported outcomes (PROs) in clinical trials, but a substantial proportion of applications seeking product approval lack these data.

All articles by Jody A. Charnow
A 62-year-old man received a genetically modified pig kidney at Massachusetts General Hospital.
Investigators report 5-year follow-up data from a phase 2 clinical trial.
Use of an SGLT2 inhibitor instead of other classes of glucose-lowering agents is associated with lower kidney stone risk.
Avacopan plus rituximab offers a superior remission rate at 52 weeks and lower risk of relapse compared with prednisone taper plus rituximab, with a similar safety profile.
Investigators reported findings from the phase 3 PROTECT and DUPLEX trials.
Investigators report findings from one of the largest cohorts of patients treated with androgen receptor pathway inhibitors.
Latest observation follows reports of new autoimmune phenomena following COVID-19 vaccination, such as IgA nephropathy, rheumatoid arthritis, and systemic lupus erythematosus, investigators noted.
Investigators report 36-month data from the phase 2b ORIGIN trial.
The phase 3 EMBARK trial involved more than 200 global sites and had 8 years of follow-up.
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