The draft guidance, which also covers instrument selection and trial design considerations, coincides with increased emphasis throughout the industry on the incorporation of patient-reported outcome measure (PROM) data in regulatory decision making and drug labelling.
TORONTO (PRWEB) October 14, 2021
In June 2021, the US FDA issued draft guidance entitled, “Core Patient-Reported Outcomes in Cancer Trials,” to provide clinical research sponsors with recommendations for the collection of patient-reported outcomes (PROs) in oncology trials. The draft guidance, which also covers instrument selection and trial design considerations, coincides with increased emphasis throughout the industry on the incorporation of patient-reported outcome measure (PROM) data in regulatory decision making and drug labelling.
In this webinar, Signant’s clinical experts provide a summary, as well as interpretation and analysis, of the draft guidance with a view to establish foundations for future study design and planning.
Register for this important virtual event to learn about these key elements of the guidance through the lens of Signant’s electronic clinical outcome assessment (eCOA) scientific experts, with featured topics including:
- Measure selection – evaluation of commonly-used instruments to measure the core concepts outlined in the guidance
- Frequency of PROM administration – study design considerations accounting for FDA’s thinking on the timing and frequency of assessments, how this challenges current measurement approaches, and implications for data collection.
- Implementation considerations– the use of electronic solutions for PROM administration, patient acceptance considerations, PROM selection/adaptation, and data integrity strategies for future oncology trial designs that meet the new guidance
Don’t miss this opportunity to hear from industry experts with experience in over 350 oncology trials on how they expect this draft guidance to impact future research in this therapeutic area.
Join Signant Health’s Dr. Bill Byrom, Principal, eCOA Science and Dr. Jill Platko, Senior Scientific Advisor, for the live webinar on Tuesday, November 2, 2021 at 10am EDT (2pm GMT/UK).
For more information, or to register for this event, visit Oncology eCOA – What the New FDA Draft Guidelines Tell Us.
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