In oncology clinical research, patient reported outcomes (PRO) have historically been collected on paper. The FDA describes PRO as measurements “based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without interpretation of the patient’s response by a clinician or anyone else.”1 Today, PRO is leveraged as a broad term that may include patient-reported information about symptoms, treatment side effects, functional outcomes, emotional or cognitive functioning, and health-related quality of life (HRQOL).
Along with the growth in all clinical research digital technologies, electronic PRO (ePRO) deployment has increased due to improving ease of use, better data quality, and real-time access to site and patient data for remote monitors and sponsors. As the technology continues to improve and costs decrease, ePRO is expected to become an even more standard practice across the clinical research industry.
This white paper describes a unique, agile ePRO deployment methodology used by Clinical Ink, a global clinical trial technology company, discusses the benefits of using ePRO in oncology trials, and explains why this agile process is beneficial for oncology trials.