SCOPE Europe 2023
The summit for clinical ops executives is a two-day event for innovation and digital leaders, clin ops executives and those responsible for planning and managing clinical trials worldwide, to share best practices and discuss the new era of decentralized, analytics-driven and patient-centric trials. Clario’s Director of eCOA Clinical Science and Consulting, Kelly Dumais, Ph.D., will present the results of a clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences. She will be joined by be Garry Beran, Director Digital Health Oncology R&D at AstraZeneca for a Q&A session. In addition, Bryan McDowell, VP eCOA Clinical Science and Consulting, will join a panel to discuss “Moving eCOA, ePRO, e-SOURCE, EDC, and any other “e” into reality in a digital health world”.
Session Information:
Conference Program: Clinical Data Technology for Digital and Hybrid Trials
Session 1:
Title: Marrying accessibility and data integrity – the importance of science
Date: October 18, 2023
Time: 1400 CET
Abstract:
Regulatory bodies are demanding greater accessibility to trials, leading sponsors to ask for these functionalities to be included in clinical trials. Even though accessibility supports inclusivity, to date these recommendations have not truly materialised into actions and in many cases, where accessibility functionalities have been deployed, these functionalities have not undergone appropriate scientific validation to assess any potential impact on data integrity.
In this session, we will present the results of Clario’s industry-first clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences.
Speakers
Kelly Dumais, Ph.D.
Director, eCOA Science and Consulting at Clario
Dr. Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently the Director of eCOA Science and Consulting at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
Garry Beran
Director Digital Health Oncology R&D at AstraZeneca
Session 2:
Title: Moving eCOA, ePRO, e-SOURCE, EDC, and any other “e” into reality in a digital health world.
Date: October 18, 2023
Time: 1100 CET
Moderator: Lisa Henderson – Editorial Director, Applied Clinical Trials
Clario Panelist
Bryan McDowell, M.Sc., M.B.A.
VP, eCOA Clinical Science and Consulting at Clario
In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma-wide industry necessity for smarter drug & device development and life cycle management.
Other panelists:
Estrella Garcia Alvarez, Ph.D. – Director, Global Clinical Operations, R&D, Almirall SA
Scottie Kern – Executive Director, eCOA Consortium, Critical Path Institute
Danielle Middleton, Ph.D. – MBBChir, Associate Medical Director, Patient Safety Physician Digital and Devices, AstraZeneca