Pith Number

pith:T6XPIJZO

pith:2026:T6XPIJZOORRKY5G4XFKPP4RNK6

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Evaluating the impact of outcome delay on the efficiency of sample size re-estimation

Aritra Mukherjee, James J M S Wason, Michael J Grayling

Outcome delays during recruitment inflate final sample sizes and power in sample size re-estimation trials

arxiv:2605.12797 v1 · 2026-05-12 · stat.ME · stat.AP

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Claims

C1strongest claim

The results indicate that with increase in delay length, the delay impact increases, inflating average sample size and power. However, the severity of the effect of delayed outcomes depends highly on the exact trial setting. Trials where the reestimated sample size is smaller than originally planned suffer the most from delayed outcomes, often leading to an overpowered trial.

C2weakest assumption

The modeling assumes continuous recruitment during outcome delays and specific distributions for continuous and binary outcomes, without detailed accounting for variable recruitment rates or other real-world factors like dropouts.

C3one line summary

Outcome delays in internal pilot sample size re-estimation inflate average sample size and power, with strongest effects when re-estimated sizes are smaller than originally planned.

References

26 extracted · 26 resolved · 0 Pith anchors

[1] G., Royston, P., and Holder, R 2006

[2] Chang, M. (2014). Adaptive Design Theory and Implementation Using SAS and R. In CRC press (2nd ed.). CRC Press, Taylor and Francis Group 2014

[3] promising zone 2020 · doi:10.1186/s13063-020-04931-w

[4] European Medicines Agency.http://www.ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2009/09/WC500003616.pdf 2007

[5] Friede T, and Kieser M. (2002). On the inappropriateness of an EM algorithm based procedure for blinded sample size re-estimation. Statistics in Medicine. 30;21(2):165-76. https://onlinelibrary.wiley. 2002 · doi:10.1002/sim.977

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Receipt and verification

First computed	2026-05-18T03:09:12.779833Z
Builder	pith-number-builder-2026-05-17-v1
Signature	Pith Ed25519 (`pith-v1-2026-05`) · public key
Schema	pith-number/v1.0

Canonical hash

9faef4272e7462ac74dcb954f7f22d5798e38071d94a0861907e7fbaaec911b9

Aliases

arxiv: 2605.12797 · arxiv_version: 2605.12797v1 · doi: 10.48550/arxiv.2605.12797 · pith_short_12: T6XPIJZOORRK · pith_short_16: T6XPIJZOORRKY5G4 · pith_short_8: T6XPIJZO

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Verify this Pith Number yourself

curl -sH 'Accept: application/ld+json' https://pith.science/pith/T6XPIJZOORRKY5G4XFKPP4RNK6 \
  | jq -c '.canonical_record' \
  | python3 -c "import sys,json,hashlib; b=json.dumps(json.loads(sys.stdin.read()), sort_keys=True, separators=(',',':'), ensure_ascii=False).encode(); print(hashlib.sha256(b).hexdigest())"
# expect: 9faef4272e7462ac74dcb954f7f22d5798e38071d94a0861907e7fbaaec911b9

Canonical record JSON

{
  "metadata": {
    "abstract_canon_sha256": "162732ffbc8c04c19c8f8a563957c90c2df6dee766b912c4d993ac1deaeed73b",
    "cross_cats_sorted": [
      "stat.AP"
    ],
    "license": "http://creativecommons.org/licenses/by/4.0/",
    "primary_cat": "stat.ME",
    "submitted_at": "2026-05-12T22:26:52Z",
    "title_canon_sha256": "518841114310b99171c4f27de8b1a89c2c8454f5724f74aef2cbad50d0f0fd2b"
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  "source": {
    "id": "2605.12797",
    "kind": "arxiv",
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