Analysis of Regional Timelines To Set Up a Global Phase III Clinical Trial in Breast Cancer: the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Experience

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dc.contributor.author Metzger-Filho, Otto
dc.contributor.author Azambuja, Evandro de
dc.contributor.author Bradbury, Ian
dc.contributor.author Saini, Kamal S.
dc.contributor.author Bines, Jose
dc.contributor.author Simon, Sergio D. [UNIFESP]
dc.contributor.author Van Dooren, Veerle
dc.contributor.author Aktan, Gursel
dc.contributor.author Pritchard, Kathleen I.
dc.contributor.author Wolff, Antonio C.
dc.contributor.author Smith, Ian
dc.contributor.author Jackisch, Christian
dc.contributor.author Lang, Istvan
dc.contributor.author Untch, Michael
dc.contributor.author Boyle, Frances
dc.contributor.author Xu, Binghe
dc.contributor.author Baselga, Jose
dc.contributor.author Perez, Edith A.
dc.contributor.author Piccart-Gebhart, Martine
dc.date.accessioned 2016-01-24T14:31:10Z
dc.date.available 2016-01-24T14:31:10Z
dc.date.issued 2013-02-01
dc.identifier http://dx.doi.org/10.1634/theoncologist.2012-0342
dc.identifier.citation Oncologist. Durham: Alphamed Press, v. 18, n. 2, p. 134-140, 2013.
dc.identifier.issn 1083-7159
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/35904
dc.description.abstract Purpose. This study measured the time taken for setting up the different facets of Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO), an international phase III study being conducted in 44 participating countries.Methods. Time to regulatory authority (RA) approval, time to ethics committee/institutional review board (EC/IRB) approval, time from study approval by EC/IRB to first randomized patient, and time from first to last randomized patient were prospectively collected in the ALTTO study. Analyses were conducted by grouping countries into either geographic regions or economic classes as per the World Bank's criteria.Results. South America had a significantly longer time to RA approval (median: 236 days, range: 21-257 days) than Europe (median: 52 days, range: 0-151 days), North America (median: 26 days, range: 22-30 days), and Asia-Pacific (median: 62 days, range: 37-75 days). Upper-middle economies had longer times to RA approval (median: 123 days, range: 21-257 days) than high-income (median: 47 days, range: 0-112 days) and lower-middle income economies (median: 57 days, range: 37-62 days). No significant difference was observed for time to EC/IRB approval across the studied regions (median: 59 days, range 0-174 days). Overall, the median time from EC/IRB approval to first recruited patient was 169 days (range: 26-412 days).Conclusion. This study highlights the long time intervals required to activate a global phase III trial. Collaborative research groups, pharmaceutical industry sponsors, and regulatory authorities should analyze the current system and enter into dialogue for optimizing local policies. This would enable faster access of patients to innovative therapies and enhance the efficiency of clinical research. the Oncologist 2013; 18: 134-140 en
dc.description.sponsorship GlaxoSmithKline
dc.format.extent 134-140
dc.language.iso eng
dc.publisher Alphamed Press
dc.relation.ispartof Oncologist
dc.rights Acesso aberto
dc.subject Activation en
dc.subject Phase III clinical trials en
dc.subject Ethics committee/institutional review board en
dc.title Analysis of Regional Timelines To Set Up a Global Phase III Clinical Trial in Breast Cancer: the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Experience en
dc.type Artigo
dc.contributor.institution Dana Farber Canc Inst
dc.contributor.institution Univ Libre Brussels
dc.contributor.institution Breast European Adjuvant Study Team BrEAST Data C
dc.contributor.institution Inst Jules Bordet
dc.contributor.institution Breast Int Grp
dc.contributor.institution Grp Brasileiro Estudos Canc Mama GBECAM São Paulo
dc.contributor.institution INCA
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution GlaxoSmithKline
dc.contributor.institution Univ Toronto
dc.contributor.institution Johns Hopkins Kimmel Comprehens Canc Ctr
dc.contributor.institution Royal Marsden Hosp
dc.contributor.institution Inst Canc Res
dc.contributor.institution Natl Inst Oncol
dc.contributor.institution HELIOS Klin
dc.contributor.institution Chinese Acad Med Sci
dc.contributor.institution Mem Sloan Kettering Canc Ctr
dc.contributor.institution SOLTI Breast Canc Res Grp
dc.contributor.institution Mayo Clin
dc.description.affiliation Dana Farber Canc Inst, Div Womens Canc, Boston, MA 02215 USA
dc.description.affiliation Univ Libre Brussels, Brussels, Belgium
dc.description.affiliation Breast European Adjuvant Study Team BrEAST Data C, Brussels, Belgium
dc.description.affiliation Inst Jules Bordet, Dept Med Oncol, B-1000 Brussels, Belgium
dc.description.affiliation Breast Int Grp, Brussels, Belgium
dc.description.affiliation Grp Brasileiro Estudos Canc Mama GBECAM São Paulo, São Paulo, Brazil
dc.description.affiliation INCA, Inst Nacl Canc, Rio de Janeiro, Brazil
dc.description.affiliation Universidade Federal de São Paulo, Dept Oncol Clin, São Paulo, Brazil
dc.description.affiliation GlaxoSmithKline, Collegeville, PA USA
dc.description.affiliation Univ Toronto, Sunnybrook Odette Canc Ctr, Toronto, ON, Canada
dc.description.affiliation Johns Hopkins Kimmel Comprehens Canc Ctr, Dept Oncol, Baltimore, MD USA
dc.description.affiliation Royal Marsden Hosp, Breast Unit, London SW3 6JJ, England
dc.description.affiliation Inst Canc Res, London SW3 6JB, England
dc.description.affiliation Natl Inst Oncol, Dept Med Oncol, Budapest, Hungary
dc.description.affiliation HELIOS Klin, Dept Gynecol & Obstet, Berlin, Germany
dc.description.affiliation HELIOS Klin, Multidisciplinary Breast Canc Ctr, Berlin, Germany
dc.description.affiliation Chinese Acad Med Sci, Canc Inst & Hosp, Beijing 100730, Peoples R China
dc.description.affiliation Mem Sloan Kettering Canc Ctr, Div Hematol Oncol, New York, NY 10021 USA
dc.description.affiliation SOLTI Breast Canc Res Grp, Barcelona, Spain
dc.description.affiliation Mayo Clin, Ctr Canc, Jacksonville, FL 32224 USA
dc.description.affiliationUnifesp Universidade Federal de São Paulo, Dept Oncol Clin, São Paulo, Brazil
dc.identifier.doi 10.1634/theoncologist.2012-0342
dc.description.source Web of Science
dc.identifier.wos WOS:000315880300003



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