Provide a hypothesis and rationale for biomarker utility and a description of the impact on therapeutic agent development based on the following considerations: Biological and/or mechanistic rationale with data to support relationship between biomarker and agent effects Intended use within the proposed study Preclinical in vitro and in vivo, and clinical results, if applicable Describe the assay and appropriateness for the study method’s validity Describe the experience and competence with the proposed assays investigator’s Provide the data supporting the degree of biomarker for and “fit purpose” clinical qualification Justify the number of patients and specimens: To demonstrate feasibility To demonstrate that studies are likely to produce interpretable and meaningful results Give thoughtful consideration to the risk to the patient of obtaining samples, specimens, or data for biomarker studies in the context of data on biomarker validity and degree of clinical qualification 9.3 Laboratory Correlative Studies 9.1.1 (Title Laboratory Correlative Study #1) – 9.1.1.1 Collection of Specimen(s) 9.1.1.2 Handling of Specimens(s) 9.1.1.3 Shipping of Specimen(s) 9.1.1.4 Site(s) Performing Correlative Study 9.1.2 (Title Laboratory Correlative Study #2) – 9.1.2.1 Collection of Specimen(s) 9.1.2.2 Handling of Specimens(s) 9.1.2.3 Shipping of Specimen(s) 9.1.2.4 Site(s) Performing Correlative Study 9.4 Special Studies 9.2.1 (Title Special Correlative Study #1) – 9.2.1.1 Outcome Measure 9.2.1.2 Assessment 9.2.1.2.1 Method of Assessment 9.2.1.2.2 Timing of Assessment 9.2.1.3 Data Recording 9.2.1.3.1 Method of Recording 9.2.1.3.2 Timing of Recording 10. STUDY CALENDAR Schedules shown in the Study Calendar below are provided as an example and should be modified as appropriate.
Provide a hypothesis and rationale for biomarker utility and a description of the impact on therapeutic agent development based on the following considerations: Biological and/or mechanistic rationale with data to support relationship between biomarker and agent effects Intended use within the proposed study Preclinical in vitro and in vivo, and clinical results, if applicable Describe the assay method’s validity and appropriateness for the study Describe the investigator’s experience and competence with the proposed assays Provide the data supporting the degree of biomarker “fit for purpose” and clinical qualification Justify the number of patients and specimens: To demonstrate feasibility To demonstrate that studies are likely to produce interpretable and meaningful results Give thoughtful consideration to the risk to the patient of obtaining samples, specimens, or data for biomarker studies in the context of data on biomarker validity and degree of clinical qualification 9.3 Laboratory Correlative Studies 9.1.1 (Title – Laboratory Correlative Study #1) 9.1.1.1 Collection of Specimen(s) 9.1.1.2 Handling of Specimens(s) 9.1.1.3 Shipping of Specimen(s) 9.1.1.4 Site(s) Performing Correlative Study 9.1.2 (Title – Laboratory Correlative Study #2) 9.1.2.1 Collection of Specimen(s) 9.1.2.2 Handling of Specimens(s) 9.1.2.3 Shipping of Specimen(s) 9.1.2.4 Site(s) Performing Correlative Study 9.4 Special Studies 9.2.1 (Title – Special Correlative Study #1) 9.2.1.1 Outcome Measure 9.2.1.2 Assessment 9.2.1.2.1 Method of Assessment 9.2.1.2.2 Timing of Assessment 9.2.1.3 Data Recording 9.2.1.3.1 Method of Recording 9.2.1.3.2 Timing of Recording 10. STUDY CALENDAR Schedules shown in the Study Calendar below are provided as an example and should be modified as appropriate.
Hepatic_Dysfunction_Template_v4.docx