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.
Source record
Citations copied verbatim from the method’s source record. No claim-level verification is inferred from them.
- 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
Curated claims
Claims persisted in the evidence ledger, each with its own assessment.
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.