Discussion Group

How to Measure Success in a Decentralized Trial

Thursday, September 30, 2021, 9:45 AM - 11:15 AM

Over the past year, it is estimated that one quarter of all clinical studies have included a decentralized component or components. We have seen the way we collect clinical research data significantly change due to COVID related travel restrictions. We have seen the increase of data collection from virtual/telehealth visits, home health providers in a patient’s home, and wearable medical devices. Our tools for measuring performance and success within these types of studies need to change to stay relevant to this new paradigm.

Traditional data management metrics are mostly centered paper-based metrics and EDC based metrics. Currently there isn’t any mention of metrics for decentralized trials. Metrics such as ‘the number of days from Patient Visit complete to eCRF page entered in EDC system’ may not be relevant with direct data capture technologies. Some items such as ‘Calendar days from time query generated to query response on EDC system’ are no longer measured in days or weeks, but oftentimes can be measured in hours.

This presentation will provide thought leadership on a new analytics methodology to measure the compliance, timeliness and quality in a decentralized trials environment.

Facilitators: