How to Balance Prognostic Factors in Controlled Phase II Trials: Stratified Permuted Block Randomization or Minimization? An Analysis of Clinical Trials in Digestive Oncology.
In controlled phase II trials, major prognostic factors need to be well balanced between arms. The main procedures used are SPBR (Stratified Permuted Block Randomization) and minimization. First, we provide a systematic review of the treatment allocation procedure used in gastrointestinal oncology c...
| Publicado en: | Current Oncology Vol. 31; no. 6; pp. 3513 - 3529 |
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| Autores principales: | , , , , , , , , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
MDPI
Jun2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=178152604&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 178152604 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 11980052 5EKK jtl: Current Oncology issn: 11980052 maglogo: N pubinfo: dt: Jun2024 vid: 31 iid: 6 pid: 97109 pub: MDPI artinfo: ui: 178152604 10.3390/curroncol31060259 178152604 ppf: 3513 ppct: 16 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: How to Balance Prognostic Factors in Controlled Phase II Trials: Stratified Permuted Block Randomization or Minimization? An Analysis of Clinical Trials in Digestive Oncology. aug: au: Martin, Elodie Le Malicot, Karine Guérin-Charbonnel, Catherine Bocquet, François Bouché, Olivier Turpin, Anthony Aparicio, Thomas Legoux, Jean-Louis Dahan, Laetitia Taieb, Julien Lepage, Côme Dourthe, Louis-Marie Pétorin, Caroline Bourgeois, Vincent Raoul, Jean-Luc Seegers, Valérie affil: Institut de Cancérologie de l'Ouest, F 49055 Angers, France sug: ab: In controlled phase II trials, major prognostic factors need to be well balanced between arms. The main procedures used are SPBR (Stratified Permuted Block Randomization) and minimization. First, we provide a systematic review of the treatment allocation procedure used in gastrointestinal oncology controlled phase II trials published in 2019. Second, we performed simulations using data from six phase II studies to measure the impacts of imbalances and bias on the efficacy estimations. From the 40 articles analyzed, all mentioned randomization in both the title and abstract, the median number of patients included was 109, and 77.5% were multicenter. Of the 27 studies that reported at least one stratification variable, 10 included the center as a stratification variable, 10 used minimization, 9 used SBR, and 8 were unspecified. In real data studies, the imbalance increased with the number of centers. The total and marginal imbalances were higher with SBR than with minimization, and the difference increased with the number of centers. The efficiency estimates per arm were close to the original trial estimate in both procedures. Minimization is often used in cases of numerous centers and guarantees better similarity between arms for stratification variables for total and marginal imbalances in phase II trials. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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