# E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials: Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/e9r1-statistical-principles-for-clinical-trials-addendum-estimands-and-sensitivity-analysis-in-clinical-trials-guidance-for-industry/e136fe4a-71f3-4725-890a-e85d5d6c6414 > FDA guidance document: E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials: Guidance for Industry. Issue date: May 11, 2021. Get complete insights and analysis. --- ## Details - Title: E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials: Guidance for Industry - Communication Type: Guidance Document - Product Type: biologics - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2021-05-11 - Last Changed: 2021-05-11 - Docket Number: FDA-2017-D-6113 ## Related Documents - [Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/adjusting-for-covariates-in-randomized-clinical-trials-for-drugs-and-biological-products/f58b2adc-b92a-4458-b269-5346d25a8a39) - [Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex](https://www.globalkeysolutions.net/guidances/guidance-document/q12-technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management-annex/5379f689-7e71-423b-b00d-e8c8654bbd0b) - [S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/s5r3-detection-of-reproductive-and-developmental-toxicity-for-human-pharmaceuticals-guidance-for-industry/b68debd9-c581-404c-b7fd-963716474af6)