Formal Statistical Testing and Inference in Randomized Phase II Trials in Medical Oncology

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorSAAD, Everardo D.
dc.contributor.authorSASSE, Emma C.
dc.contributor.authorBORGHESI, Gustavo
dc.contributor.authorMIRANDA, Vanessa C.
dc.contributor.authorFEDE, Angelo B. S.
dc.contributor.authorSAAD, Lucas S.
dc.contributor.authorOLIVEIRA, Vinicius
dc.contributor.authorBARROS, Eduardo A. C.
dc.contributor.authorPASCOIN, Maira
dc.contributor.authorGIGLIO, Auro del
dc.contributor.authorRIECHELMANN, Rachel
dc.date.accessioned2013-09-23T16:50:07Z
dc.date.available2013-09-23T16:50:07Z
dc.date.issued2013
dc.description.abstractObjectives: With the growing number of new anticancer therapies, randomized phase II trials have been used more often in oncology. Although the primary objective of such trials is not to formally compare results between arms, this practice seems frequent. We sought to quantify the frequency of use of formal statistical testing or inference through the use of P values and confidence intervals (CIs) in randomized phase II trials. Methods: We searched PubMed for randomized phase II trials assessing systemic cancer therapies published in the years 1995/1996 and 2005/2006. For each study, 2 reviewers independently abstracted data, including reporting of P values and CIs for the primary endpoint. Results: We retrieved 288 articles, 107 of which were eligible for analysis. The median number of patients per trial was 94, the primary endpoint was response rate in 71 (66.4%) cases, and a control arm was present in 55 (51.4%) trials. Either P values or CIs for the primary endpoint were reported in 85 (79.4%; 95% CI, 70.8%-86.1%) cases. Year of publication, source of funding, and use of a control group were not associated with this practice. Conclusions: Formal statistical comparisons between arms of randomized phase II trials are frequently undertaken in medical oncology. The extent to which such a practice abrogates phase III testing is unknown.
dc.description.indexMEDLINE
dc.identifier.citationAMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS, v.36, n.2, p.143-145, 2013
dc.identifier.doi10.1097/COC.0b013e3182436e6c
dc.identifier.issn0277-3732
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/2246
dc.language.isoeng
dc.publisherLIPPINCOTT WILLIAMS & WILKINS
dc.relation.ispartofAmerican Journal of Clinical Oncology-Cancer Clinical Trials
dc.rightsrestrictedAccess
dc.rights.holderCopyright LIPPINCOTT WILLIAMS & WILKINS
dc.subjectclinical trial
dc.subjectphase II
dc.subjectconfidence intervals
dc.subjectneoplasms
dc.subjectresearch design
dc.subjectstatistics
dc.subject.otherclinical-trials
dc.subject.otherdesign
dc.subject.othercancer
dc.subject.wosOncology
dc.titleFormal Statistical Testing and Inference in Randomized Phase II Trials in Medical Oncology
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.author.externalSAAD, Everardo D.:Dendrix Res Ltd, Sao Paulo, Brazil
hcfmusp.author.externalSASSE, Emma C.:Dendrix Res Ltd, Sao Paulo, Brazil
hcfmusp.author.externalBORGHESI, Gustavo:Dendrix Res Ltd, Sao Paulo, Brazil
hcfmusp.author.externalMIRANDA, Vanessa C.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil
hcfmusp.author.externalFEDE, Angelo B. S.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil
hcfmusp.author.externalSAAD, Lucas S.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil
hcfmusp.author.externalOLIVEIRA, Vinicius:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil
hcfmusp.author.externalBARROS, Eduardo A. C.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil
hcfmusp.author.externalPASCOIN, Maira:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil
hcfmusp.author.externalGIGLIO, Auro del:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil; Albert Einstein Jewish Hosp IEP HIAE, Res Inst, Sao Paulo, Brazil
hcfmusp.citation.scopus5
hcfmusp.contributor.author-fmusphcRACHEL SIMOES PIMENTA RIECHELMANN
hcfmusp.description.beginpage143
hcfmusp.description.endpage145
hcfmusp.description.issue2
hcfmusp.description.volume36
hcfmusp.origemWOS
hcfmusp.origem.pubmed22307212
hcfmusp.origem.scopus2-s2.0-84876155667
hcfmusp.origem.wosWOS:000316740100007
hcfmusp.publisher.cityPHILADELPHIA
hcfmusp.publisher.countryUSA
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hcfmusp.scopus.lastupdate2024-05-17
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