Studies in Support of Special Populations

ICH (1993) Harmonised Tripartite Guideline (E7). Studies in support of special populations Geriatrics. http //www.ich.org/LOB/media/MEDIA483.pdf. Cited 30 Dec 2008... 

Studies in support of special populations geriatrics Guidance on General Considerations for Clinical Trials Notice... 

Studies in Support of Special Populations Geriatrics General Considerations of Clinical Trials Statistical Principles for Clinical Trials... 

ICH-E7 (August 1994) Guideline for Industry Studies in support of special populations Geriatrics US FDA (1978) General considerations for the clinical evaluation of drugs. December 1978... 

E7 Studies in support of Special Populations Geriatrics CPMP/ICH/379/95 Step 5... 

US Food and Drag Administration. Guideline for industry Studies in support of special populations Geriatrics, ICH-E7 August 1994 available at http //www.fda.gov/cder/guidance/iche7.pdf. 

Human PK studies, including estimates of standard PK parameters, sources of variability, and evidence supporting dose and/or dose individualization in the target patient population and in special populations. 

Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure its safety and effectiveness. Therefore these devices require a premarket authorization (PMA) application in order to obtain marketing clearance. Approval of the PMA requires direct evidence of safety and effectiveness in the target population, which includes the submission of preclinical and clinical studies to support claims made for the device (FDA, 2008). According to FDA, novel devices without a predicate are automatically classified as Class III, regardless of their risk profile (Kramer et al., 2012). 

Integration of biomarkers into clinical protocols requires incorporation of biomarker analysis into one of the study objectives. For novel biomarkers this is typically achieved by including an exploratory objective that examines the feasibility of measuring the biomarkers in the study population. Within the protocol a summary of preclinical or translational evidence for the biomarkers should be provided. When available, biomarker qualifications or letters of support from regulatory authorities should be referenced. A schedule of events describing when samples for biomarker analysis should be collected in context with all other clinical visits and tests should be included. When special collection, processing, or storage considerations are required, a separate... 

---