Date: Monday, November 6, 2023
Time: 15:45 – 16:15
Conference track: Afternoon seminar
Seminar Title: Enhancing accessibility to clinical trials without jeopardizing data integrity
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 materialized 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. We will also explore additional remote data collection technologies, such as home blood pressure and ECG collection, with a particular focus on how to enhance accessibility without compromising on optimal data quality.
Vice President, eCOA Science and Consulting at Clario
In his role as VP, eCOA Science and Consulting, Bryan McDowell 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 and visionary and continues to influence, drive and deliver on the pharma-wide industry necessity for smarter drug and device development and life cycle management.
Chief Medical Officer at Clario
As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging Clario’s scientific resources to support customer success, Dr. Rudo has focused efforts on developing expertise across a range of therapeutic areas. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data.
Date: Tuesday, November 7, 2023
Conference Track: Poster Session
Title: Completion rate and time analysis of electronic quality of life measures.
Authors: Reina Davis-Aoki, Kelly Dumais
Quality of life (QOL) measures are critical to assess patients’ health in clinical trials. With regulatory attention on reducing burden, we analyzed the impact of QOL type on completion rate and time.
Patients completed assessments electronically on Clario Tablet devices at clinical trial sites . Operational data for completion status (Done or Not Done) and duration of time to complete (in seconds) was extracted for 4 commonly used patient-reported QOL measures: EQ-5D-5L (5 levels or severity), EQ-5D-3L (3 levels of severity), SF-36v2 Standard and SF-36v2 Acute.
The sample included 119 studies across different phases, with 120,565instances of completion status analyzed for the 4 QOL measures. The mean completion rates were 95.4% (EQ-5D-5L), 96.5% (EQ-5D-3L), 96.1% (SF-36v2 Standard) and 99.0% (SF-36v2 Acute). The study specific median time for form completion was 80s for EQ-5D-5L (range 43-157s), 65s for EQ-5D-3L (range 17-114s), 354s for SF-36v2 Standard (range 129-455s) and 384s for SF-36v2 Acute (range 256-7840s). Completion rate was not associated with the form completion time The analysis of instances where the assessments were completed at home was not feasible due to the limited sample size. Additional analysis of home-based assessments will determine whether the compliance is location dependent.
Completion compliance was high for all tablet QOL measures regardless of completion time or number of questions. This suggests that longer QOL measures may not negatively impact compliance at site, and that electronic measures have benefits of yielding high compliance and enhanced data quality.
Clinical Science Associate at Clario
Dr. Reina Davis-Aoki, Ph.D., brings over a decade of expertise in life science and engineering research and has experience in electronic reported outcomes (eCOAs) implementation and clinical research participant and rater training developments. She currently serves as a Clinical Science Associate for eCOA Science and Consulting at Clario, a global data and technology company dedicated to risk mitigation in clinical trials. Dr. Davis-Aoki holds a Ph.D. in Genetics and also an engineering degree.
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