FDA Requests Feedback on LOINC Coding for Clinical Trial Lab Results
The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes.
Specifically, the agency wants to know how it can promote use of LOINC given the many subsets created to facilitate easier coding. Should the FDA, for example, identify a specific LOINC subset for use, and, if so, should the agency create its own subset or use existing ones? In the case of the latter, which LOINC subsets should the agency consider?
Each LOINC code refers to a single test result and allows laboratories to specify the type of sample being tested, the substance and purpose of the test, the time frame of the measurement and the test method used to produce the result. Clinical laboratory testing for hepatitis C, for example, might specify that the test measured the level of hepatitis C antigen in a patient’s blood at a specific time or over a specific period of time.
Comments are due June 28 to regulations.gov, docket no. FDA-2015-N-1349. Read the Federal Register notice at www.fdanews.com/05-13-15-codes.pdf. — Lena Freund