Patient-reported outcome measurements in clinical trials in Saudi Arabia: A cross-sectional analysis of ClinicalTrials.gov
1From the Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Kingdom of Saudi Arabia.
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Summary
Forty percent of Saudi Arabian interventional trials utilize patient-reported outcomes (PROs). Further efforts are needed to increase PRO adoption and generate local evidence in clinical research.
Area of Science:
- Clinical Trials
- Health Outcomes Research
- Saudi Arabian Healthcare
Background:
- Patient-reported outcomes (PROs) are crucial for capturing patient experiences in clinical research.
- Understanding PRO utilization in interventional trials is essential for evidence generation.
Purpose of the Study:
- To quantify the use of PROs in interventional trials conducted in Saudi Arabia.
- To identify factors influencing PRO usage in these trials.
Main Methods:
- A systematic search of ClinicalTrials.gov identified interventional trials in Saudi Arabia.
- Trials were categorized based on the mention of PROs in their outcomes.
- Chi-square tests analyzed associations between PRO use and trial characteristics.
Main Results:
- Out of 933 trials, 40% reported PROs as primary, secondary, or both outcomes.
- Pain was the most frequently reported PRO.
- Non-industry-sponsored trials, non-drug interventions, phase 3 trials, and trials exclusively in Saudi Arabia showed higher PRO use.
Conclusions:
- Forty percent of registered clinical trials in Saudi Arabia incorporated at least one PRO.
- Addressing barriers to PRO use is vital for enhancing local evidence generation.