Discussion on Proposed Change to MolecularBiomarker Definition
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Proposed Change to MolecularBiomarker Definition (row 52)
Original Definition
DEFINITION: An individual mutation that alone or together with other mutations contributes to a medical conclusion.
EXAMPLE(S): L10I, K20R, M36I, A71V, V82T
OTHER NAME(S): Biological State
NOTE(S):
Ballot Comment
A mutation is only one type of molecular biomarker. A molecular biomarker does not have to yield a medical-level conclusion. This suggestion is similar to the NIH Biomarkers Definitions Working Group definition.
Proposed Definition
DEFINITION: An individual mutation that alone or together with other mutations contributes to a medical conclusion.
TYPO CORRECTION - PROPOSED DEFINITION IS ACTUALLY: A molecular biological characteristic that can be evaluated as an indicator of biological functions, processes, or therapeutic responses.
EXAMPLE(S): L10I, K20R, M36I, A71V, V82T <= SHOULD THESE BE CONSISTENT WITH THE EXAMPLE SCENARIO USED ACROSS ALL MOLECULAR BIOLOGY CLASSES???
OTHER NAME(S): Biological State
NOTE(S):
Proposed Disposition
Persuasive
Proposed Disposition Comment
Review proposed change with PGx SMEs to ensure change is consistent with their original use case for the concept. Also see disposition comments and recommendation on Gene item a few rows above. Should the two definitions be harmonized?
Outstanding Questions
- CDISC PGx SMEs: Is the proposed change consistent with your original use case for MolecularBiomarker?
- Anyone: Can someone provide a comprehensive, realistic and meaningful set of example values that uses the same overall scenario across all classes in the Molecular Biology sub-domain?
Responses
Please add your responses here...
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