LECTURE 10 2011

LECTURE 10 2011 - Outline General endpoint considerations...

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Outline General endpoint considerations Surrogate endpoints Composite endpoints Safety outcomes (adverse events)
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Types of Safety Outcomes (1) Adverse events that require reporting to regulatory authorities S erious A dverse E vents (SAEs) S uspected U nexpected S erious A dverse R eaction (SUSARs) Adverse events for planned treatment comparisons Treatment discontinuation due to adverse effects Severe adverse effects according standard grading table Open-ended Side effect check-list
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Types of Safety Outcomes (2) Another way of thinking of the categorization: Case reports of individual events Data on case report form with which to compute counts and rates by treatment group Both are important (refer to week 1 notes for discussion of case summaries)
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Guidance Documents International Conference on Harmonization (ICH) of Technical Requirements of Pharmaceuticals for Human Use Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A Regulatory authorities have reporting requirements for adverse events Code of Federal Regulations (CFR) Title 21, Part 312 describes safety reporting for investigational drugs (trials being carried out under an IND with the FDA) EU Directive provides guidance for reporting safety data for investigational medicinal products
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Serious Events Definition – ICH Guidelines Events resulting in death Life-threatening events Events leading to hospitalization or prolonging existing hospitalization Events leading to persistent/significant disability or incapacity Congenital abnormalities/birth defects Other important medical events that may jeopardize the participant or require intervention to prevent one of the other outcomes above
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Other Definitions Unexpected – an adverse drug experience which is not consistent with the current investigator brochure (or label for approved drug) Related – cannot rule out the possibility that the treatment caused the adverse event (i.e., the investigator cannot check “not related”)
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SUSARs SUSAR= S uspected U nexpected S erious A dverse R eaction SUSAR reporting is required by the European Union (EU) Directive 2001/20/EC for all trials being conducted at sites in the European Economic Area (EEA) that use investigational medicinal products (IMPs)
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What is a SUSAR? Serious : per ICH GCP Guideline E2A Unexpected : per labeling of the suspect agent Suspected adverse reaction : related to treatment
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Reporting Serious Adverse Events For trials that we do we require serious events to be reported on all participants, regardless of treatment status or relationship to study treatment (attribution is unreliable and hard to standardize). This allows a
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This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

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LECTURE 10 2011 - Outline General endpoint considerations...

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