OBJECTIVES : To evaluate the degree to which clinicaltrials.gov (“ct.gov”) or linked publications report the inclusion of patient-reported outcomes (PROs) in cancer trials compared to FDA submission documents.

METHODS : We reviewed trial documents (e.g. protocols, clinical study reports) submitted to FDA for trials of approved products malignant disease, supportive care for malignant disease, and blood disorders from 2007 – 2017. We identified the PROs collected in these trials. Using National Clinical Trial Identifiers, we evaluated the documentation of PROs. We noted if PROs were: 1) listed on the ct.gov website, 2) not listed on the site but available via a linked publication, or 3) not listed anywhere.

RESULTS : We identified 103 trials from FDA submissions containing 256 PROs. Trials could contain >1 PRO and different PROs could be classified as different objective types. PROs were secondary objectives in 65 trials and exploratory objectives in 41 trials. Of the 256 PROs, 114 (45%) were listed as trial measures on ct.gov, 54 (21%) were available via linked publications, and 49 (19%) were found in protocols or other supplements of linked publications. 39 (15%) PROs identified in FDA documents were not specified anywhere through ct.gov. PROs that were secondary objectives were more likely to be listed under ct.gov than PROs designated as exploratory objectives (55/65 trials (85%) versus 2/41 trials (5%) for secondary versus exploratory objectives, respectively). For 41 trials with exploratory PRO objectives, 19 PROs (46%) were available through linked publications and 17 (41%) available through protocols or supplements on linked publications only.

CONCLUSIONS : PROs in cancer trials are uncommonly reported as trial measures on the ct.gov webpage, particularly when classified as exploratory objectives. Easier identification of trials with PROs is important for both patients and researchers interested in knowing more about the patient experience while on experimental drugs.