From: Principles and recommendations for incorporating estimands into clinical study protocol templates
Implement the estimand framework in all studies | |
Define estimands early in the CSP with a sufficient level of detail | |
Keep description of intercurrent events and their strategies at a relatively high level in the objectives section to engage non-statisticians and for readability, add and refer to details in a separate section later in the CSP | |
Name the estimands for ease of referencing estimands in later sections or other documents | |
Describe the clinical question(s) of interest to engage non-statisticians if less detailed objectives are used | |
Describe the rationale for the choice of key estimands | |
Align study design and conduct with the defined estimands, including, e.g. the collection of details on intercurrent events and study intervention(s) | |
Differentiate between discontinuation of treatment/intervention and study withdrawal | |
Distinguish between intercurrent events and missing data |