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  • Ich E9 (r1) Addendum On Estimands And Sensitivity

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1 2 330 August 2017 EMA/CHMP/ICH/436221/2017 Committee for Human Medicinal Products6ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles.

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Sensitivity analysis determines how different values of an independent variable affect a particular dependent variable under a given set of assumptions. In other words, sensitivity analyses study how various sources of uncertainty in a mathematical model contribute to the model's overall uncertainty.

'Sensitivity analysis' aims to investigate whether the results of important analyses are sensitive or robust to violations of the assumptions by performing analyses addressing a specific clinical question under contrasting assumptions.

This document provides guidance on the design, conduct, analysis and evaluation of clinical trials of an investigational product in the context of its overall clinical development.

An estimand consists of five attributes: treatment, population, variable, population-level summary, and handling of intercurrent events. Each of these attributes is defined in an interdisciplinary discussion during the trial planning phase, based on the clinical question being asked.

To perform sensitivity analysis, we follow these steps: Define the base case of the model; Calculate the output variable for a new input variable, leaving all other assumptions unchanged; Calculate the sensitivity by dividing the % change in the output variable over the % change in the input variable.

The International Council for Harmonization (ICH) has issued ICH E9 (R1) training materials meant to improve the planning, design, analysis and interpretation of clinical trials by defining suitable estimands.

A sensitivity analysis is a method to determine the robustness of trial findings by examining the extent to which results are affected by changes in methods, models, values of unmeasured variables, or assumptions.

An example of a sensitivity analysis would be to calculate how much a business can increase its prices, before it starts to negatively affect customer sales. In this example, it is a way to see how sensitive your customers are to changing prices, so a business can gauge how much to increase them by.

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Divorce
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Employment
Identity Theft
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Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232