Building a Robust Investigator-Initiated Platform: The I-CARE Experience - PubMed
7 days ago
- #Inflammatory bowel disease
- #Investigator-initiated studies
- #Patient-reported outcomes
- Investigator-initiated studies with patient-collected data are increasing, but there's limited data on patient and investigator experiences.
- The I-CARE cohort involved IBD patients from 15 countries collecting clinical data monthly for up to 6 years.
- 79.3% of patients completed more than one ePRO, and 77.3% completed at least one ePRO within 6 months before the study ended.
- 72.8% and 56.4% of patients completed all ePROs in year 1 and 3, respectively.
- Early withdrawal predictors included male gender, younger age (<20), unemployment/student status, and no history of abdominal surgery.
- Investigators corrected 52.5% of patient-reported cancer/dysplasia cases vs. 10% of serious infections.
- Treatment sequences were added or removed by investigators for 19.6% of 6,708 patients on biologics.
- The study highlights patient involvement in research, the importance of data validation, and challenges in collecting patient medical data.