MALVERN, P.A. - September 13, 2019 - This webinar will discuss the current regulatory climate as well as the process of expert screen review, a new and less expensive practice for ensuring psychometric equivalence of instruments migrated to a new platform when only minor changes are required. Special considerations for Bring Your Own Device (BYOD) studies will be discussed.
The use of electronic clinical outcome assessments (eCOA) is surging in clinical trials. Despite this trend, there is still some hesitation to embrace eCOA for fear that building an electronic version of an existing COA may “break” an instrument’s psychometric properties.
Fortunately, regulatory guidance and industry best practices have helped researchers to ensure modification to validated COAs when migrated to electronic platform has not undermined the instruments’ measurement properties. Guidance documents recommend mode equivalence studies of varying levels of complexity and associated cost, dependent on the extent to which an instrument is “changed” when migrated to a different mode of administration. The recommended studies can be expensive and time-intensive– requiring recruitment of 10-75 patients and up to 6-9 months to design, execute and analyze the study data.
In recent literature, eCOA experts suggested that mode equivalence testing may be eliminated for instruments that require only minor modifications when migrated to a new mode of administration, provided industry best practices for faithful migration are followed and the resulting screens undergo expert screen review.
Join the live webinar on Thursday, October 10, 2019 at 11am EDT (4pm BST/UK). The featured speakers Celeste A. Elash, Director of eCOA Sciences at YPrime and Willie Muehlhausen, Managing Director at Muehlhausen Ltd. will also be on hand to answer audience questions.
For more information or to register for this event, visit Expert Screen Review Instead of Mode Equivalence Testing: Who are the Experts?