ICH E9(R1), Addendum on Estimands and Sensitivity Analysis in Clinical Trials¶
International Council for Harmonisation. (2019). ICH E9(R1), Addendum on Estimands and Sensitivity Analysis in Clinical Trials.
Cited by¶
1 citation across 1 artifact.
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Primes¶
- External Analytic Challenge
- A challenge with identical content delivered at the end of the trial produces a critique, and delivered here produces a different trial. Mapped back: the protocol is the revisable work, the programme's accumulated history is the authoring frame, the unaffiliated reviewers are the outside station while their access to the prior reports is what makes them competent rather than merely independent, the estimand and dropout questions are probes rather than reactions, the response table is the recorded obligation, and first dose is the threshold the whole arrangement is scheduled against.
This sourceSpecifies the estimand and intercurrent-event questions a trial protocol must settle before the trial starts, which is what makes them probes rather than post-hoc critique.
- A challenge with identical content delivered at the end of the trial produces a critique, and delivered here produces a different trial. Mapped back: the protocol is the revisable work, the programme's accumulated history is the authoring frame, the unaffiliated reviewers are the outside station while their access to the prior reports is what makes them competent rather than merely independent, the estimand and dropout questions are probes rather than reactions, the response table is the recorded obligation, and first dose is the threshold the whole arrangement is scheduled against.
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Registry ID ref:f33cdc528185 · see in the full table