Please use this identifier to cite or link to this item:
https://observatorio.fm.usp.br/handle/OPI/2246
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor | Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP | - |
dc.contributor.author | SAAD, Everardo D. | - |
dc.contributor.author | SASSE, Emma C. | - |
dc.contributor.author | BORGHESI, Gustavo | - |
dc.contributor.author | MIRANDA, Vanessa C. | - |
dc.contributor.author | FEDE, Angelo B. S. | - |
dc.contributor.author | SAAD, Lucas S. | - |
dc.contributor.author | OLIVEIRA, Vinicius | - |
dc.contributor.author | BARROS, Eduardo A. C. | - |
dc.contributor.author | PASCOIN, Maira | - |
dc.contributor.author | GIGLIO, Auro del | - |
dc.contributor.author | RIECHELMANN, Rachel | - |
dc.date.accessioned | 2013-09-23T16:50:07Z | - |
dc.date.available | 2013-09-23T16:50:07Z | - |
dc.date.issued | 2013 | - |
dc.identifier.citation | AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS, v.36, n.2, p.143-145, 2013 | - |
dc.identifier.issn | 0277-3732 | - |
dc.identifier.uri | https://observatorio.fm.usp.br/handle/OPI/2246 | - |
dc.description.abstract | Objectives: 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.language.iso | eng | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.relation.ispartof | American Journal of Clinical Oncology-Cancer Clinical Trials | - |
dc.rights | restrictedAccess | - |
dc.subject | clinical trial | - |
dc.subject | phase II | - |
dc.subject | confidence intervals | - |
dc.subject | neoplasms | - |
dc.subject | research design | - |
dc.subject | statistics | - |
dc.subject.other | clinical-trials | - |
dc.subject.other | design | - |
dc.subject.other | cancer | - |
dc.title | Formal Statistical Testing and Inference in Randomized Phase II Trials in Medical Oncology | - |
dc.type | article | - |
dc.rights.holder | Copyright LIPPINCOTT WILLIAMS & WILKINS | - |
dc.identifier.doi | 10.1097/COC.0b013e3182436e6c | - |
dc.identifier.pmid | 22307212 | - |
dc.subject.wos | Oncology | - |
dc.type.category | original article | - |
dc.type.version | publishedVersion | - |
hcfmusp.author.external | SAAD, Everardo D.:Dendrix Res Ltd, Sao Paulo, Brazil | - |
hcfmusp.author.external | SASSE, Emma C.:Dendrix Res Ltd, Sao Paulo, Brazil | - |
hcfmusp.author.external | BORGHESI, Gustavo:Dendrix Res Ltd, Sao Paulo, Brazil | - |
hcfmusp.author.external | MIRANDA, Vanessa C.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil | - |
hcfmusp.author.external | FEDE, Angelo B. S.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil | - |
hcfmusp.author.external | SAAD, Lucas S.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil | - |
hcfmusp.author.external | OLIVEIRA, Vinicius:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil | - |
hcfmusp.author.external | BARROS, Eduardo A. C.:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil | - |
hcfmusp.author.external | PASCOIN, Maira:ABC Med Sch FMABC, Div Oncol, Dept Clin Oncol & Haematol, Sao Paulo, Brazil | - |
hcfmusp.author.external | GIGLIO, 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.description.beginpage | 143 | - |
hcfmusp.description.endpage | 145 | - |
hcfmusp.description.issue | 2 | - |
hcfmusp.description.volume | 36 | - |
hcfmusp.origem | WOS | - |
hcfmusp.origem.id | WOS:000316740100007 | - |
hcfmusp.origem.id | 2-s2.0-84876155667 | - |
hcfmusp.publisher.city | PHILADELPHIA | - |
hcfmusp.publisher.country | USA | - |
hcfmusp.relation.reference | Chen EX, 2009, J CLIN ONCOL S, V27 | - |
hcfmusp.relation.reference | Gray R, 2006, CLIN CANCER RES, V12, P1966, DOI 10.1158/1078-0432.CCR-05-1136 | - |
hcfmusp.relation.reference | Green S, 2003, CLIN TRIALS ONCOLOGY, P58 | - |
hcfmusp.relation.reference | Lee JJ, 2005, J CLIN ONCOL, V23, P4450, DOI 10.1200/JCO.2005.03.197 | - |
hcfmusp.relation.reference | LEE YJ, 1981, SEMIN ONCOL, V8, P403 | - |
hcfmusp.relation.reference | Liu PY, 1999, CONTROL CLIN TRIALS, V20, P343, DOI 10.1016/S0197-2456(99)00009-4 | - |
hcfmusp.relation.reference | Perrone F, 2003, LANCET ONCOL, V4, P305, DOI 10.1016/S1470-2045(03)01078-7 | - |
hcfmusp.relation.reference | Rubinstein L, 2009, CLIN CANCER RES, V15, P1883, DOI 10.1158/1078-0432.CCR-08-2031 | - |
hcfmusp.relation.reference | Rubinstein LV, 2005, J CLIN ONCOL, V23, P7199, DOI 10.1200/JCO.2005.01.049 | - |
hcfmusp.relation.reference | SIMON R, 1985, CANCER TREAT REP, V69, P1375 | - |
hcfmusp.relation.reference | Stenning S, 2003, CLIN TRIALS CANC PRI, P30 | - |
hcfmusp.relation.reference | Stone A, 2007, CONTEMP CLIN TRIALS, V28, P138, DOI 10.1016/j.cct.2006.05.009 | - |
hcfmusp.relation.reference | Thall PF, 1996, J CLIN ONCOL, V14, P296 | - |
hcfmusp.relation.reference | WITTES RE, 1985, CANCER TREAT REP, V69, P1235 | - |
hcfmusp.relation.reference | Zia MI, 2005, J CLIN ONCOL, V23, P6982, DOI 10.1200/JCO.2005.06.679 | - |
dc.description.index | MEDLINE | - |
hcfmusp.citation.scopus | 5 | - |
hcfmusp.scopus.lastupdate | 2024-04-12 | - |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - HC/ICESP Artigos e Materiais de Revistas Científicas - ODS/03 |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
art_RIECHELMANN_Formal_Statistical_Testing_and_Inference_in_Randomized_Phase_2013.PDF Restricted Access | publishedVersion (English) | 128 kB | Adobe PDF | View/Open Request a copy |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.