Last Updated: September 25, 2019 5:57PM
The ABCs of COAs
It’s no secret: Clinical trials are complicated, with a process made all the more arduous by accelerating timelines, escalating costs, rising regulations, and demands for demonstrable data. Yet every trial starts with three simple questions:
A) Is the drug or therapy safe for patients?
B) Does it demonstrate a treatment benefit?
C) Do the treatment benefits outweigh the risks?
Answering these questions—and receiving regulatory approval—relies in large part on data derived from Clinical Outcome Assessments (COAs). By measuring how patients feel and function in their everyday lives, COA tools provide the quantifiable evidence to support therapeutic claims made in drug labeling. Determining the most appropriate COA for a given trial requires pre-study planning to identify stakeholders and minimize variance amid plentiful variables and challenges.
In this new whitepaper from Lionbridge Life Sciences, we explore key translation challenges related
to COA and trial planning and design. We’ll also examine the fast-rising trend of digitizing COAs with Electronic Clinical Outcome Assessments (eCOAs)—and the impact of capturing clinical data electronically.
Ready to learn how to plan for translation at every step of the COA process? Download the whitepaper today!