Danone Nutricia Research decided to evaluate the effect of three fermented milk products against a control arm to deepen associated health claims. This study, designed to evaluate the effects of fermented milk products on bowel functions, was a randomized, double-blind, controlled adaptive study.
Some of the study objectives were heavily dependent on patient-reported outcomes, including assessing (via questionnaires) changes on objective and subjective markers of bowel functions over several weeks of consumption and assessing study product satisfaction after consumption. The study called for 150 patients who were selected based on specific questionnaires and randomized to one of four balanced arms. Patient self-assessments include a validated instrument of assessment of bowel functions marker based on a referential picture and two other primary validated instruments on Symptoms and Quality of Life. Other questionnaires were used to track the study product intake, assess the compliance of subject habits (e.g., diet, physical activity) with the study protocol and follow safety parameters (e.g., adverse event, medication) during the study.
The Solution: Rave eCOA/ePRO
The unified Rave EDC and Rave eCOA/ePRO integration was natural choice that fit flawlessly with the data strategy envisioned for this study by the Danone Nutricia Research’s data management team. The Rave eCOA/ePRO mobile app was the best option for mobility and real-time data collection. The Danone Nutricia Research team provided subjects with Apple iPad Minis as compensation for participation while also serving as a platform for the Rave eCOA/ePRO app. Patients would be able to keep the iPad only if they remained on the study for the entire duration so it served as motivation for both recruitment and retention.
The study team had instant visibility to patient self assessments which enabled an adaptive study. The electronic, real-time PRO data collection allowed for improved data quality because of the immediate data quality check capabilities. Rave eCOA/ePRO easily adapted to Danone Nutricia Research’s existing data management workflow, which included the use of external design tools based on CDISC ODM (XML) and they were able to reduced study startup costs by leveraging Medidata's enablement services to setup the study on their own. The calendar functionality within the Rave eCOA/ePRO app encouraged subjects to complete questionnaires on a timely basis, minimizing recall bias and ensuring the highest quality data while simulantously improving the patient experience.