federal_register: 2011-19140
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-19140 | Review and Qualification of Clinical Outcome Assessments; Public Workshop | Notice | The Food and Drug Administration (FDA) is announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer-reported outcome (ObsRO) measures. This public workshop is intended to provide information for and gain perspectives from patient advocates, health care providers, researchers, regulators, individuals from academia, industry, and other interested persons on various aspects of the development and implementation of COAs in the evaluation of treatment benefit. Regulatory review issues regarding context of use and documentation of the measurement properties of a COA will be covered during panel discussions. The input from this public workshop will be published in the form of a white paper or a series of manuscripts. | 2011-07-28 | 2011 | 7 | https://www.federalregister.gov/documents/2011/07/28/2011-19140/review-and-qualification-of-clinical-outcome-assessments-public-workshop | https://www.govinfo.gov/content/pkg/FR-2011-07-28/pdf/2011-19140.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures,... |