Are analyses after the CSR prohibited?

No. Address their rationale, methods, timing and interpretation transparently.

Does a reviewer request make an analysis prespecified?

The request explains its origin; it does not turn a later question into one planned at study start.

Post-CSR Analyses: Making Later Questions Visible in Publication

Published: 28 October 2026
Updated: 28 October 2026

New analysis questions can arise while preparing a paper after completion of the clinical study report. Presenting a later calculation as part of the original plan makes it harder for readers to understand how the evidence was produced.

The publication decision

Document the new question, its proposer and the context of data access. Distinguish prespecified work from analyses developed later. Relevant experts should define the dataset version, methods and review needed. A new analysis should not obscure the principal study finding merely because it offers a more attractive narrative or a more favourable result.

Worked example

For example, a reviewer requests an additional comparison in one subgroup. The team links the analysis to that request, explains that it was conducted later and submits the statistical approach for authorised review. Even if the result is favourable, methods and interpretive boundaries remain explicit. Publication records explain why the output differs from the original CSR.

Coordination checks

Record the analysis question and when it emerged.
Link dataset and method versions to the proposed publication table.
Check labels and interpretive limits for later analyses in the text.

Acceptance and boundaries

Acceptance means readers can distinguish planned evidence from questions developed afterwards. Additional analysis is not inherently unnecessary and may improve scientific understanding, but appropriate methodological expertise remains essential. This coordination control does not itself verify statistical adequacy. Preserve traceable relationships with earlier reports and make material differences explainable to authors, reviewers and later readers.

Frequently asked questions

Are analyses after the CSR prohibited?: No. Address their rationale, methods, timing and interpretation transparently.
Does a reviewer request make an analysis prespecified?: The request explains its origin; it does not turn a later question into one planned at study start.