On behalf of the Critical Path Institute (C-Path) Florence Mowlem PhD, led this much-needed project, providing 10 best practices for EDeD design and implementation to support clinical trial data capture, along with co-authors from Top 10 pharma, clinical trial technology providers, and regulators, published in Nature Digital Medicine
BOSTON and LONDON, Dec. 15, 2025 /PRNewswire-PRWeb/ -- uMotif – one of the clinical trial technology market's fastest growing companies – continues contributing to major innovations in how clinical trial patient data are collected, with Chief Scientific Officer Florence Mowlem PhD, guiding best practice recommendations for the use of event-driven eDiaries (EDeDs) in clinical trials. The result of this extensive effort is featured in Nature Digital Medicine.
The project, on behalf of C-Path's Electronic Clinical Outcome Assessment Consortium (eCOAC) and Patient-Centered Evidence Consortium (PCEC, previously known as the Patient-Reported Outcome Consortium), included Dr. Mowlem and 23 co-authors from uMotif, Lilly; Suvoda; UCB; AstraZeneca; AbbVie; Clario; Medidata; Parexel International; FDA; GSK; Otsuka; Novartis; Signant Health; Critical Path Institute; IQVIA; and Medrio. For a full list of authors, click here.
Based on an extensive literature review and the collective experience and consensus of the authors, this article provides clear considerations for the use of EDeDs, and detailed best practice recommendations for their design and implementation in clinical trials.
Scottie Kern, Executive Director of the eCOAC, commented, "We were approached coincidentally by FDA, a sponsor representative, and Flo in the space of a week asking if any best practices for EDeDs existed, and, if not, that it was necessary to do so. Having an established and successful forum of eCOA technology, allied service providers and sponsors, Critical Path Institute's Electronic Clinical Outcome Assessment Consortium and Patient-Centered Evidence Consortium (previously known as the Patient-Reported Outcome Consortium) were perfectly positioned to collaborate with FDA on this critically important resource to the benefit of both regulators and the broader medical product development community."
Collecting data in an event-driven manner is especially beneficial and appropriate for clinical study designs where a change in the number of occurrences of a given event informs the endpoint, or high-resolution information is wanted about the occurrence. This form of data capture can offer more immediate and granular information about individual events, potentially reducing burden associated with recalling details of an event sometime after its occurrence, while increasing the accuracy of reported data.
In this critical paper, the authors provide detailed recommendations for several areas, including defining what data to capture; the importance of specifying the reporter; device strategy; defining how the event will be captured; ensuring the same event is not recorded multiple times; reminder scheduling; data entry time window; electronic implementation best practices; usability considerations; and compliance monitoring. This project represents the first major guidance on EDeDs in over a decade and fills a significant gap in providing recommendations to optimize data quality in clinical trials and to support a necessary level of standardization using this form of data capture.
"We see event-driven data capture used across a wide range of therapeutic areas to understand the efficacy of new treatments, and support regulatory approvals and labeling claims," Dr. Mowlem explained. "We felt it was important to ensure the ease of use and practical application of the recommendations in the paper, and provide several examples of how the practices outlined can be applied to TA-specific use cases, including for Developmental and Epileptic Encephalopathy, Hemophilia, Overactive Bladder, and Hypoglycemia."
About uMotif
Putting patients first is in uMotif's DNA. The modern uMotif eCOA platform delivers faster, high-quality clinical trials and real-world studies by putting patients at the core of research. Combined with uMotif's robust site tools – including consent management, site productivity, and trial awareness – the platform strengthens the patient-site relationship, which is key to improving eCOA compliance and retention. With cloud hosting in the US, Europe, and China, the GCP, 21 CFR Part 11 and GDPR-compliant platform supports all study phases and indications. Visit www.umotif.com
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