Patient-reported outcome measurements in clinical trials in Saudi Arabia: A cross-sectional analysis of ClinicalTrials.gov.

Objectives: To quantify use of patient-reported outcomes (PROs) in interventional trials conducted in Saudi Arabia and to determine whether PRO usage varies according to key trial characteristics.

Methods: The ClinicalTrials.gov database was searched to identify all interventional trials located in Saudi Arabia. Two authors screened each trial's primary and secondary outcomes and categorized each trial into: (1) trials in which PROs were mentioned or (2) trials in which PROs were not mentioned. The Chi-square test was used to examine associations between PRO use and certain trial characteristics.

Results: The search identified 933 trials. Forty percent (n=371) reported PROs as primary (n=141, 38%) or secondary (n=178, 48%) outcomes or both (n=52, 14%). The number of PRO instruments was 535. Pain was the most common PRO (n=164, 31%). Trials characteristics associated with more use of PROs included nonindustry-sponsored trials, trials focusing on nondrug interventions, phase 3 trials and trials conducted exclusively in Saudi Arabia.

Conclusion: Forty percent of the registered clinical trials in Saudi Arabia used at least one PRO. This highlights the need to address barriers to PRO use to facilitate generation of local evidence.