Building a Robust Investigator‐Initiated Platform: The I‐ <scp>CARE</scp> Experience

Investigator-initiated studies that include information collected by patients are rising, but limited data is available on patient and investigator experience in this setting. The I-CARE cohort included patients with inflammatory bowel disease (IBD) monthly collecting clinical information in 15 countries for up to 6 years. We describe patients and investigators' involvement in I-CARE and identify predictors of early withdrawal due to patient non-engagement. Patients' characteristics according to the number of electronic Patient-reported outcomes (ePRO) completed during follow-up were assessed. Predictors of early withdrawal due to patient non-engagement were identified using logistic regression. The coding of outcomes reported by patients and corrections by investigators on patients' ePROs were assessed. Among 12,846 patients included by 502 investigators, 79.3% and 77.3% filled more than one ePRO and at least one ePRO within 6 months before the study end date, respectively. All ePROs were completed in 72.8% and 56.4% of patients during year 1 and 3, respectively. Male gender, younger age (< 20), being unemployed or a student, and no previous history of abdominal surgery were associated with early withdrawal. Investigators corrected 52.5% of cancer or dysplasia reported by patients compared to 10% of serious infections. Investigators added or removed a treatment sequence in 19.6% of the 6708 patients treated with biologics. These results highlight the implication of patients in research and the importance of data validation by investigators alongside the challenge and potential of collecting medical data from patients. These findings can inform similar future initiatives in other diseases. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).

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Journal
Clinical Pharmacology & Therapeutics
Published
2026-02-15
DOI
https://doi.org/10.1002/cpt.70231
Primary Topic
Mental Health and Patient Involvement
Type
article
Field-Weighted Citation Impact
0.00

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article

Building a Robust Investigator‐Initiated Platform: The I‐ CARE Experience

Peter J. Rimmer, Edyta Zagórowicz, Daniel Bergemalm, Nikos Viazis et al.
Clinical Pharmacology & Therapeutics
Mental Health and Patient Involvement
article

Building a Robust Investigator‐Initiated Platform: The I‐ CARE Experience

Peter J. Rimmer, Edyta Zagórowicz, Daniel Bergemalm, Nikos Viazis, Hélène Rousseau, Anne Buisson, B Caron, Aditi Kumar, Luisa Avedano, Parker Girod, Filip J. Baert, Fiorella Cañete, Jessica Thut, I Goren, T Holvoet, S Dias, Juliette Sheridan, Laurent Beaugerie, Jean‐François Rahier, Cédric Baumann, Susanne Krasz, Klaudia Farkas, Petra Weimers, Mathieu Uzzan, Julien Kirchgesner, I‐CARE Collaborator Group, Shaji Sebastian
article en

Abstract

Investigator-initiated studies that include information collected by patients are rising, but limited data is available on patient and investigator experience in this setting. The I-CARE cohort included patients with inflammatory bowel disease (IBD) monthly collecting clinical information in 15 countries for up to 6 years. We describe patients and investigators' involvement in I-CARE and identify predictors of early withdrawal due to patient non-engagement. Patients' characteristics according to the number of electronic Patient-reported outcomes (ePRO) completed during follow-up were assessed. Predictors of early withdrawal due to patient non-engagement were identified using logistic regression. The coding of outcomes reported by patients and corrections by investigators on patients' ePROs were assessed. Among 12,846 patients included by 502 investigators, 79.3% and 77.3% filled more than one ePRO and at least one ePRO within 6 months before the study end date, respectively. All ePROs were completed in 72.8% and 56.4% of patients during year 1 and 3, respectively. Male gender, younger age (< 20), being unemployed or a student, and no previous history of abdominal surgery were associated with early withdrawal. Investigators corrected 52.5% of cancer or dysplasia reported by patients compared to 10% of serious infections. Investigators added or removed a treatment sequence in 19.6% of the 6708 patients treated with biologics. These results highlight the implication of patients in research and the importance of data validation by investigators alongside the challenge and potential of collecting medical data from patients. These findings can inform similar future initiatives in other diseases. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).

Clinical Pharmacology & Therapeutics
University Hospitals Birmingham NHS Foundation Trust (GB), Inserm (FR), University of Hull (GB), Université Paris-Est Créteil (FR), SUNY Upstate Medical University (US), University of Szeged (HU), Örebro University (SE), Hull University Teaching Hospitals NHS Trust (GB), Paris-Est Sup (FR), Rabin Medical Center (IL), Hull Royal Infirmary (GB), Portuguese Army (PT), Sorbonne Université (FR), Zealand University Hospital (DK), Centre Hospitalier Régional et Universitaire de Nancy (FR), Instituto Português de Oncologia Francisco Gentil (PT), Centro de Investigación Biomédica en Red (ES), St. Vincent's University Hospital (IE), National Institute of Oncology (HU), Vlaamse Vereniging voor Obstetrie en Gynaecolo (BE), Hôpitaux Universitaires Henri-Mondor (FR), Institut Pierre Louis d‘Épidémiologie et de Santé Publique (FR), Montavid Thermodynamic Research Group (HU), AZ Delta (BE), The Maria Sklodowska-Curie National Research Institute of Oncology (PL), Hospital Universitari Germans Trias i Pujol (ES), The Royal Wolverhampton NHS Trust (GB), Ospedale Eugenio Morelli (IT), Association François Aupetit (FR), Klinik und Poliklinik für Psychotherapie und Psychosomatik (DE), Evangelismos Hospital (GR), Nutrition-Génétique et Exposition aux Risques Environnementaux (FR), Interdisciplinarité en Santé Publique Interventions et Instruments de mesure complexes – Région Est (FR), Université de Lorraine (FR), UCLouvain (BE)
Amgen, Pfizer
Openalex Percentile: Top 57%
Mental Health and Patient Involvement
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