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Paper Citation Record · LEDGER

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies

As of 11 August 2026, this Paper Citation Record lists 22 of 22 outbound references and 0 inbound Pith citation observations for arXiv:2605.23246.

A citation records a reference. It does not transfer a finding from one paper to another.

pith.paper-citation-record.v1
2605.23246 v1

Coverage vector

measured 22 of 22 reference resolution

Typed states for the displayed outbound observations.

Source: paper_references, paper_reference_links, observed 2026-05-25T03:09:57.872792Z

measured 22 of 22 standing notices

One-hop event checks from named stored sources.

Source: scholarly_work_events, retraction_status_cache, observed 2026-08-11T06:34:44.6726+00:00

measured 0 of 0 inbound itemization

Pith citing papers itemized under the disclosed page cap.

Source: paper_references, paper_reference_links

measured 0 of 1 external citation measurements

A source-named dated measurement, never combined with another source.

Source: cited_works

Reference resolution

22 of 22 outbound references displayed

  • verified exact14
  • verified fuzzy8
  • unresolved0
  • parse uncertain0
  • malformed identifier0
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External citation measurements

No source-named external measurement is stored.

Outbound references

Observation 3ddcb0b3-38c0-4511-a774-01f27d19b94d · outbound

This paper cites Smith1, Tala Fakhouri2, Run Zhuang1, Jonathan R.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Smith1, Tala Fakhouri2, Run Zhuang1, Jonathan R

Reference 1

Resolution
verified fuzzy
raw_fallback, observed 2026-05-25T03:10:17.377457Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation b42ac21e-bee5-4451-858b-4e5c16ec87b8 · outbound

This paper cites Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review

Reference 2

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verified fuzzy
raw_fallback, observed 2026-05-25T03:10:17.381290Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 7772b67d-9fbd-4f62-813b-418e2d39aa5e · outbound

This paper cites an unresolved cited work.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Unresolved cited work

Reference 3

Resolution
verified exact
doi, observed 2026-05-25T03:10:15.378303Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation a15feb19-a6a2-4f2c-b41c-29dd698b6987 · outbound

This paper cites Increasing the efficiency of randomized trial estimates via linear adjustment for a prognostic score.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Increasing the efficiency of randomized trial estimates via linear adjustment for a prognostic score

Reference 4

Resolution
verified fuzzy
raw_fallback, observed 2026-05-25T03:10:17.373845Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation a3a564fa-fa3e-4aff-851c-7175bf5c08d7 · outbound

This paper cites an unresolved cited work.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Unresolved cited work

Reference 5

Resolution
verified exact
doi, observed 2026-05-25T03:10:15.385695Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 91dfcce3-77ac-43f3-b24b-0ed32332c0b8 · outbound

This paper cites The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies

Reference 6

Resolution
verified fuzzy
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Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation bbe0ba44-085a-4c15-8e29-233292319321 · outbound

This paper cites an unresolved cited work.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Unresolved cited work

Reference 7

Resolution
verified exact
doi, observed 2026-05-25T03:10:15.392904Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 5c9b37c6-fd02-4e31-a524-4873d8018033 · outbound

This paper cites Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

Reference 8

Resolution
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Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 0d1f3e51-4699-4df8-bd01-d4051fae148d · outbound

This paper cites Enhancing Longitudinal Clinical Trial Efficiency with Digital Twins and Prognostic Covariate-Adjusted Mixed Models for Repeated Measures (PROCOVA-MMRM).

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Enhancing Longitudinal Clinical Trial Efficiency with Digital Twins and Prognostic Covariate-Adjusted Mixed Models for Repeated Measures (PROCOVA-MMRM)

Reference 9

Resolution
verified exact
arxiv_id, observed 2026-05-25T03:10:16.850970Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation eec109fe-1719-4fad-95bd-331871ec3f89 · outbound

This paper cites Prognostic Covariate Adjustment for Logistic Regression in Randomized Controlled Trials.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Prognostic Covariate Adjustment for Logistic Regression in Randomized Controlled Trials

Reference 10

Resolution
verified exact
arxiv_id, observed 2026-05-25T03:10:16.855952Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation c3c657c3-b019-48d9-8164-219b5f5a1d98 · outbound

This paper cites Prognostic Covariate Adjustment for Binary Outcomes Using Stratification.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Prognostic Covariate Adjustment for Binary Outcomes Using Stratification

Reference 11

Resolution
verified exact
arxiv_id, observed 2026-05-25T03:10:16.859983Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 20eebc6e-f4fb-4d4e-b80b-50749fc264f5 · outbound

This paper cites Restricted mean survival time estimate using covariate adjusted pseudovalue regression to improve precision.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Restricted mean survival time estimate using covariate adjusted pseudovalue regression to improve precision

Reference 12

Resolution
verified exact
arxiv_id, observed 2026-05-25T03:10:16.837667Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 33bbc935-e940-4ce5-874e-43aa02dbca5c · outbound

This paper cites Bayesian prognostic covariate adjustment.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Bayesian prognostic covariate adjustment

Reference 13

Resolution
verified exact
arxiv_id, observed 2026-05-25T03:10:16.842105Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation fc4b0294-3835-4eb0-94cd-442b5a5ea757 · outbound

This paper cites Bayesian Prognostic Covariate Adjustment With Additive Mixture Priors.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Bayesian Prognostic Covariate Adjustment With Additive Mixture Priors

Reference 14

Resolution
verified exact
arxiv_id, observed 2026-05-25T03:10:16.846087Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 4b33a2d5-92bb-4ba8-897e-c9a0e229cb42 · outbound

This paper cites Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance

Reference 15

Resolution
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raw_fallback, observed 2026-05-25T03:10:17.366452Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 1333d114-2e24-4bbd-bb64-32af1375f72c · outbound

This paper cites Using AI-generated digital twins to boost clinical trial efficiency in Alzheimer's disease.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Using AI-generated digital twins to boost clinical trial efficiency in Alzheimer's disease

Reference 16

Resolution
verified fuzzy
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Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation b1e10695-3da6-4e24-82a8-07941bb5eca6 · outbound

This paper cites an unresolved cited work.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Unresolved cited work

Reference 17

Resolution
verified exact
doi, observed 2026-05-25T03:10:15.382258Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 1b04150b-664e-4cce-b728-f400e53deec3 · outbound

This paper cites Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study

Reference 18

Resolution
verified exact
doi, observed 2026-05-25T03:10:15.370479Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation f668b268-882d-49ae-af53-1097625776eb · outbound

This paper cites Docosahexaenoic Acid Supplementation and Cognitive Decline in Alzheimer Disease: A Randomized Trial.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies Docosahexaenoic Acid Supplementation and Cognitive Decline in Alzheimer Disease: A Randomized Trial

Reference 19

Resolution
verified exact
arxiv_id, observed 2026-05-25T03:10:15.401381Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 02a06918-7acb-4a7c-a14b-0d4e9a56174f · outbound

This paper cites A randomized, double-blind, placebo-controlled trial of resveratrol for Alzheimer disease.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies A randomized, double-blind, placebo-controlled trial of resveratrol for Alzheimer disease

Reference 20

Resolution
verified exact
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Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 79e2e074-7690-4c41-aabf-83993c50a862 · outbound

This paper cites The ADCS valproate neuroprotection trial: Primary efficacy and safety results.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies The ADCS valproate neuroprotection trial: Primary efficacy and safety results

Reference 21

Resolution
verified fuzzy
raw_fallback, observed 2026-05-25T03:10:17.385022Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Observation 7b3cda7c-49d4-47d0-8b2f-b69ba10fdcb1 · outbound

This paper cites if my study is powered to 90%, how problematic is a 3.2% power decrease?.

Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies if my study is powered to 90%, how problematic is a 3.2% power decrease?

Reference 22

Resolution
verified exact
doi, observed 2026-05-25T03:10:15.389883Z

Source-reported events for the cited work

No event found in the named queried sources as of 2026-08-11T06:34:44.6726+00:00.

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Pith citing papers

No inbound Pith citation observations are available.