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Table 1 Key recommendations

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