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

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

Author Metzger-Filho, Otto Google Scholar
Azambuja, Evandro de Google Scholar
Bradbury, Ian Google Scholar
Saini, Kamal S. Google Scholar
Bines, Jose Google Scholar
Simon, Sergio D. Autor UNIFESP Google Scholar
Van Dooren, Veerle Google Scholar
Aktan, Gursel Google Scholar
Pritchard, Kathleen I. Google Scholar
Wolff, Antonio C. Google Scholar
Smith, Ian Google Scholar
Jackisch, Christian Google Scholar
Lang, Istvan Google Scholar
Untch, Michael Google Scholar
Boyle, Frances Google Scholar
Xu, Binghe Google Scholar
Baselga, Jose Google Scholar
Perez, Edith A. Google Scholar
Piccart-Gebhart, Martine Google Scholar
Institution Dana Farber Canc Inst
Univ Libre Brussels
Breast European Adjuvant Study Team BrEAST Data C
Inst Jules Bordet
Breast Int Grp
Grp Brasileiro Estudos Canc Mama GBECAM São Paulo
INCA
Universidade Federal de São Paulo (UNIFESP)
GlaxoSmithKline
Univ Toronto
Johns Hopkins Kimmel Comprehens Canc Ctr
Royal Marsden Hosp
Inst Canc Res
Natl Inst Oncol
HELIOS Klin
Chinese Acad Med Sci
Mem Sloan Kettering Canc Ctr
SOLTI Breast Canc Res Grp
Mayo Clin
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
Keywords Activation
Phase III clinical trials
Ethics committee/institutional review board
Language English
Sponsor GlaxoSmithKline
Date 2013-02-01
Published in Oncologist. Durham: Alphamed Press, v. 18, n. 2, p. 134-140, 2013.
ISSN 1083-7159 (Sherpa/Romeo, impact factor)
Publisher Alphamed Press
Extent 134-140
Origin http://dx.doi.org/10.1634/theoncologist.2012-0342
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000315880300003
URI http://repositorio.unifesp.br/handle/11600/35904

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