Difference between revisions of "Clarification on comments re InVivoCharacterization"
| Line 50: | Line 50: | ||
====Responses==== | ====Responses==== | ||
| − | + | Lauren Becnel: The denotation of the proposed definition is fine, but the connotation of the definition with the word “experiment” is awkward for clinical trials and toxicology studies. For example, you might be performing an in vivo characterization such as an MRI on a human. MRIs are standard of care. Within a clinical trial, you may have research MRIs that are part of the study, but not covered by payers as SOC for various reasons (i.e., too frequent occurrence, not recommended by AHRQ, etc.) This is then therefore a research procedure. While it is not incorrect to say this is a type of experiment,that word is not one that many trialists would use. | |
| + | |||
| + | Recommend DEFINITION: A study or an experiment whose objective is the appraisal of the biological properties of an organism or activities of a substance by testing its effect on an organism. | ||
| + | |||
| + | Q from WENDY (TYPE: DEFN): In BRIDG, an experiment can be related to a Study and since InVivoCharacterization is a subclass of Experiment, it's OK to call it that | ||
| + | if the only use case we’ve had so far is for experiments, right? We can leverage the association between a Study and an Experiment by use of the | ||
| + | ProjectRelationship class. | ||
Return to [[BRIDG]] | Return to [[BRIDG]] | ||
Revision as of 14:12, 25 February 2016
Return to BRIDG
Need clarification on comments re InVivoCharacterization (rows 9, FDA)
Ballot Comment
InVivoCharacterization as defined seems to include clinical trials and nonclinical (e.g. toxicology) studies. We need a better definition for this class, or Study is either a specialization of or synonym for this class.
Previous Definition
DEFINITION: The appraisal of the biological properties or activities of a substance by testing its effect on a organism.
EXAMPLE(S):
OTHER NAME(S):
NOTE(S):
Latest Definition
DEFINITION: An Experiment whose objective is the appraisal of the biological properties or activities of a substance by testing its effect on an organism.
EXAMPLE(S):
OTHER NAME(S):
NOTE(S):
Current Disposition
Persuasive with Mod
Proposed Disposition Comment
The definition of InVivoCharacterization came from LSDAM subject matter experts who are life sciences researchers. RECOMMENDATION: Work with life sciences SMEs and FDA representative to address this concern. Existing definition for reference: “The appraisal of the biological properties or activities of a substance by testing its effect on a organism.” DECISION: updated definition of all 3Experiment subclasses per WG discussion
Related Superclass Definitions for Reference
Project Definition: A set of coordinated activities that is intended to achieve one or more objectives.
ResearchProject Definition: A project that is intended to generate or test one or more hypotheses or lead to discoveries.
Experiment Definition: A Research Project whose objectives are to generate hypotheses or lead to discoveries.
Outstanding Question
- Does this definition need to exclude clinical trials and nonclinical studies or is that implied by the definition of its superclass (recommended)? View it in context of it’s super classes listed above.
Responses
Lauren Becnel: The denotation of the proposed definition is fine, but the connotation of the definition with the word “experiment” is awkward for clinical trials and toxicology studies. For example, you might be performing an in vivo characterization such as an MRI on a human. MRIs are standard of care. Within a clinical trial, you may have research MRIs that are part of the study, but not covered by payers as SOC for various reasons (i.e., too frequent occurrence, not recommended by AHRQ, etc.) This is then therefore a research procedure. While it is not incorrect to say this is a type of experiment,that word is not one that many trialists would use.
Recommend DEFINITION: A study or an experiment whose objective is the appraisal of the biological properties of an organism or activities of a substance by testing its effect on an organism.
Q from WENDY (TYPE: DEFN): In BRIDG, an experiment can be related to a Study and since InVivoCharacterization is a subclass of Experiment, it's OK to call it that if the only use case we’ve had so far is for experiments, right? We can leverage the association between a Study and an Experiment by use of the ProjectRelationship class.
Return to BRIDG
