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Retrospectieve Fase II Klinische Studie×Retrospectieve cohortstudie×
VakgebiedEpidemiologieEpidemiologie
FamilieProcess / pipelineProcess / pipeline
Jaar van ontstaan1980s–1990s (with growth in oncology retrospective analyses)Mid-20th century (widely formalized 1950s–1970s)
GrondleggerAdapted from standard Phase II trial methodology; retrospective variant formalized in oncology practiceSystematic use attributed to early 20th-century occupational epidemiology; formalized in modern epidemiological theory by Brian MacMahon and others
TypeObservational retrospective studyObservational analytic study
Oorspronkelijke bronSimon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials, 10(1), 1–10. DOI ↗Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
Aliassenretrospective Phase II study, historical Phase II analysis, retrospective efficacy study, Phase II retrospective analysishistorical cohort study, non-concurrent cohort study, retrospective follow-up study, historical prospective study
Verwant56
SamenvattingA retrospective Phase II clinical trial evaluates a treatment's preliminary efficacy and safety signals using existing archival data — medical records, registries, or electronic health records — rather than prospectively enrolling new patients. It mirrors the objectives of a standard Phase II trial (estimating response rate, tolerability, and early efficacy) but does so by looking backward at patients who have already received the intervention, making it faster and less costly than a prospective design.A retrospective cohort study assembles a group of individuals who share a common starting point and reconstructs their exposure history and subsequent outcomes entirely from pre-existing records. Because the data have already been collected before the study begins, the design is far faster and cheaper than a prospective cohort; however, the researcher must work with whatever information was recorded at the time rather than collecting purpose-built measurements.
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ScholarGateMethoden vergelijken: Retrospective phase II clinical trial · Retrospective Cohort Study. Geraadpleegd op 2026-06-20 via https://scholargate.app/nl/compare