In July 2009, the FDA issued a new final guidance defining clinical trial design, data and analysis requirements for drug-induced liver injury, or DILI, cases in all drug and biologic agent clinical trials.
DILI occurs in of 1 in 10,000 patients or less, and currently there is no way to predict what drugs may cause the condition, nor which subjects will be affected.
The guidance lists some specific data points that must be collected for subjects who experience DILI that go well beyond the data that is usually collected for most subjects in most trials.
This will require some considerable rethinking of how we capture and store some types of data. If you’d like to learn more, please see the lead article in the January 2010 edition of K-News, available on the News page at www.kestrelconsultants.com.
About Kit Howard
- Kit
- Ann Arbor, Michigan, United States
- Kit has 25 years of experience in visioning, developing, implementing and maintaining clinical data standards that span protocol development through regulatory submission and beyond. She believes that the foundation of data quality lies in the harmonization of all stakeholder assumptions, requirements and expectations throughout the *entire* data lifecycle. Kit currently works with CDISC as a Director of Education, and as a co-lead of the Medical Device Standards Development team. The opinions in this blog are Kit's, and do not represent those of CDISC or anyone else.
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