{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Core Patient-Reported Outcomes in Cancer Clinical Trials.\" This final guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer clinical trials and related considerations for instrument selection and trial design. This final guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/10/18/2024-24111.html","cfr_references":[],"citation":"89 FR 83884","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 18, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-2303"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-10-18","updated_at":"2024-10-18T13:56:43.622-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-2303-0030","allow_late_comments":false,"id":"FDA-2020-D-2303-0030","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-2303","title":"Core Patient-Reported Outcomes in Cancer Clinical Trials; Draft Guidance for Industry; Availability"}],"document_number":"2024-24111","effective_on":null,"end_page":83885,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/10/18/2024-24111.xml","html_url":"https://www.federalregister.gov/documents/2024/10/18/2024-24111/core-patient-reported-outcomes-in-cancer-clinical-trials-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-24111?publication_date=2024-10-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-10-18/2024-24111/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":380,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-18/pdf/2024-24111.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-24111.pdf?1729169138","publication_date":"2024-10-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/10/18/2024-24111.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-D-2303","supporting_documents_count":0,"docket_id":"FDA-2020-D-2303","document_id":"FDA-2020-D-2303-0030","regulation_id_number":null,"title":"Core Patient-Reported Outcomes in Cancer Clinical Trials; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-10-19T17:00:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":83884,"subtype":null,"title":"Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availability","toc_doc":"Core Patient-Reported Outcomes in Cancer Clinical Trials","toc_subject":"Guidance","topics":[],"type":"Notice","volume":89}