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Multicenter Phase I Clinical Trial/Evidence
Method evidence record

Multicenter Phase I Clinical Trial

A multicenter Phase I clinical trial is the first systematic administration of an investigational agent to humans, conducted simultaneously across two or more clinical sites. Its primary objectives are to characterize the safety and tolerability profile of the intervention, determine the maximum tolerated dose (MTD), and describe pharmacokinetic and pharmacodynamic behavior. Distributing enrollment across sites increases participant accrual speed and enhances the generalizability of early-phase safety data.

Sources recorded, not reviewed

Source record

Citations copied verbatim from the method’s source record. No claim-level verification is inferred from them.

Multicenter Phase I Clinical Trial
Taxonomic method record · process-pipeline / epidemiology
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). ICH. · URL
  • Storer, B. E. (1989). Design and analysis of Phase I clinical trials. Biometrics, 45(3), 925-937. · DOI 10.2307/2531693
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Curated claims

Claims persisted in the evidence ledger, each with its own assessment.

No curated claims yet

This view does not invent a claim assessment when the ledger has none.

Related methods

Generated from the method graph and shown as machine-suggested relations — no evidence claim is inferred.

Taxonomic bucketAdaptive Phase I Clinical Trialmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketBayesian Phase I clinical trialmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketDose-Response Analysismachine-suggested · Relational suggestion, not evidence.Taxonomic bucketMulticenter Randomized Clinical Trialmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketPhase I Clinical Trialmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketPhase II clinical trialmachine-suggested · Relational suggestion, not evidence.

Evidence status

Sources recorded, not reviewed

Bibliographic sources are present. Claim-level evidence review has not been performed.

Sources

2 recorded citations, copied from the method source record.

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