Like so much in the world, patient-reported outcomes (PROs) in clinical trials are now recorded digitally, offering numerous benefits.
In clinical research, a patient-reported outcome (PRO) is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician. Even in today’s day and age when researchers can use diagnostic tests to measure almost everything, PROs still play a major role in clinical research. PROs are especially used to track indications like fatigue, headache, depression, anxiety, pain, and sleep quality.1 And, like so much in the world, PROs are now recorded digitally, offering numerous benefits.
Paper Records
While PROs used to be recorded on paper, today’s digital tools make it possible to streamline this process. Traditionally, site staff provided subjects with paper diaries to record their PROs. While this approach may be cost-effective, not many are aware of its shortcomings. Below, I’ve outlined just a few of them:
Going Digital
Problems like these can directly impact the quality and outcome of a clinical trial. It’s important to transition away from paper-based PROs and move to electronic PROs (ePROs). Here’s how ePROs outperform traditional paper-based PROs:
The Future
Electronic PROs are here to stay and, when done correctly, ensure faster and better clinical trials. Being eco-friendly, they also reduce the usage of total paper in clinical trials.
About the Author
Anil Yadav is head of quality assurance at Vedic Lifesciences Pvt. Ltd. (Mumbai, India), a contract research organization (CRO) serving the dietary supplement industry by performing clinical and toxicological work. Visit https://www.vediclifesciences.com to learn more or e-mail connect@vediclifesciences.com.
Reference
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