Pith Number

pith:KMLWBGVB

pith:2026:KMLWBGVBYM4OON7JJGGT5XLDKC

not attested not anchored not stored refs resolved

A Workflow for Evaluating Regional Treatment Effect Heterogeneity in Multi-Regional Clinical Trials

Bj\"orn Bornkamp, Cong Zhang, Konstantinos Sechidis, Meihua Long, Shuhei Kaneko, Sophie Sun, Tianyu Zheng, Xiaoni Liu, Xinyi Zhang, Yan Hou, Yao Chen

A question-driven workflow with targeted statistical methods supports exploratory checks for regional treatment differences in multi-regional trials.

arxiv:2605.16885 v1 · 2026-05-16 · stat.AP · stat.ME

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\usepackage{pith}
\pithnumber{KMLWBGVBYM4OON7JJGGT5XLDKC}

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Record completeness

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2 Internet Archive

3 Author claim open · sign in to claim

4 Citations open

5 Replications open

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The bundle contains the canonical record plus signed events. A mirror can host it anywhere and recompute the same current state with the deterministic merge algorithm.

Claims

C1strongest claim

This paper proposes a structured, question-driven framework to guide exploratory assessments of regional heterogeneity in MRCTs, with a set of statistical methods to address four key questions, supported by simulation studies under scenarios with no heterogeneity and heterogeneity driven by observed or unobserved treatment effect modifiers.

C2weakest assumption

That formulating four key questions sufficiently clarifies the objectives of regional heterogeneity analyses and that the proposed statistical methods can support transparent and cautious interpretation even when the trial is not powered for regional differences.

C3one line summary

The paper introduces a question-driven framework and set of statistical methods for exploratory assessment of regional treatment effect heterogeneity in multi-regional clinical trials, evaluated via simulations under no-heterogeneity and modifier-driven scenarios.

References

72 extracted · 72 resolved · 1 Pith anchors

[1] Yusuf, Salim and Wittes, Janet and Probstfield, Jeffrey and Tyroler, Herman A. , title = ". JAMA , volume =. 1991 , month =. doi:10.1001/jama.1991.03470010097038 , url = 1991 · doi:10.1001/jama.1991.03470010097038

[2] and Sullivan, Patrick G 2017 · doi:10.1001/jamainternmed.2016.9125

[3] Regression and Other Stories , publisher=

[4] Bretz, Frank and Westfall, Peter H. , title =. Pharmaceutical Statistics , volume =. doi:10.1002/pst.1648 , url =. https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.1648 , year = · doi:10.1002/pst.1648

[5] Ruberg, Stephen J. , title =. Pharmaceutical Statistics , volume =. doi:10.1002/pst.2110 , url =. https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2110 , abstract = · doi:10.1002/pst.2110

Receipt and verification

First computed	2026-05-20T00:03:28.301216Z
Builder	pith-number-builder-2026-05-17-v1
Signature	Pith Ed25519 (`pith-v1-2026-05`) · public key
Schema	pith-number/v1.0

Canonical hash

5317609aa1c338e737e9498d3edd635081d251b1954736bad58386bf6287c5c6

Aliases

arxiv: 2605.16885 · arxiv_version: 2605.16885v1 · doi: 10.48550/arxiv.2605.16885 · pith_short_12: KMLWBGVBYM4O · pith_short_16: KMLWBGVBYM4OON7J · pith_short_8: KMLWBGVB

Agent API

Resolver JSON Graph JSON Events JSON Schema Signing key

Verify this Pith Number yourself

curl -sH 'Accept: application/ld+json' https://pith.science/pith/KMLWBGVBYM4OON7JJGGT5XLDKC \
  | 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: 5317609aa1c338e737e9498d3edd635081d251b1954736bad58386bf6287c5c6

Canonical record JSON

{
  "metadata": {
    "abstract_canon_sha256": "33a3d7c07e8ce5af7753b137423217472272a899664c260a753724833af0c5f2",
    "cross_cats_sorted": [
      "stat.ME"
    ],
    "license": "http://arxiv.org/licenses/nonexclusive-distrib/1.0/",
    "primary_cat": "stat.AP",
    "submitted_at": "2026-05-16T08:58:35Z",
    "title_canon_sha256": "2c77296190f8cc83c14d70ab257b3a2e6257e0608bdadf5c585151286b2676a5"
  },
  "schema_version": "1.0",
  "source": {
    "id": "2605.16885",
    "kind": "arxiv",
    "version": 1
  }
}