{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.\" The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance clarifies, updates, and extends the guidance for industry \"E9 Statistical Principles for Clinical Trials\" issued in September 1998 in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The guidance is intended to better align the choice of statistical methods with questions of regulatory importance and so to improve the reliability of decisions about and representations of the effects of medical products. The guidance replaces the draft guidance issued on October 31, 2017.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2021/05/12/2021-10066.html","cfr_references":[],"citation":"86 FR 26047","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 12, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-6113"],"dockets":[],"document_number":"2021-10066","effective_on":null,"end_page":26048,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/12/2021-10066.xml","html_url":"https://www.federalregister.gov/documents/2021/05/12/2021-10066/e9r1-statistical-principles-for-clinical-trials-addendum-estimands-and-sensitivity-analysis-in","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-10066?publication_date=2021-05-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-12/2021-10066/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2192,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-12/pdf/2021-10066.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10066.pdf?1620737134","publication_date":"2021-05-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/12/2021-10066.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-2017-D-6113","supporting_documents_count":0,"docket_id":"FDA-2017-D-6113","document_id":"FDA-2017-D-6113-0020","regulation_id_number":null,"title":"E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation","checked_regulationsdotgov_at":"2021-05-13T03:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26047,"subtype":null,"title":"E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}