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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| Authors: | Otto Metzger‐Filho Evandro de Azambuja Ian Bradbury Kamal S Saini José Bines Sergio D Simon Veerle Van Dooren Gursel Aktan Kathleen I Pritchard Antonio C Wolff Ian Smith Christian Jackisch Istvan Lang Michael Untch Frances Boyle Binghe Xu Jose Baselga Edith A Perez Martine Piccart‐Gebhart |
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| Institution: | 1. aDivision of Women's Cancers, Dana‐Farber Cancer Institute, Boston, Massachusetts, USA;2. bUniversité Libre de Bruxelles, Brussels, Belgium;3. cBreast European Adjuvant Study Team (BrEAST) Data Centre, Brussels, Belgium;4. dDepartment of Medical Oncology, Institut Jules Bordet, Brussels, Belgium;5. eFrontier Science, Kingussie, Kincraig, UK;6. fBreast International Group, Brussels, Belgium;7. gGrupo Brasileiro de Estudos do Cancer de Mama (GBECAM) S?o Paulo, Brazil;8. hInstituto Nacional de Cancer, INCA, Rio de Janeiro, Brazil;9. iDepartamento de Oncologia Clínica, Universidade Federal de S?o Paulo, S?o Paulo, Brazil;10. jGlaxoSmithKline, Collegeville, Pennsylvania, USA;11. kSunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada;12. lDepartment of Oncology, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA;13. mBreast Unit, Royal Marsden Hospital, and Institute of Cancer Research, London, UK;14. nDepartment of Gynecology and Obstetrics, Klinikum Offenbach, Germany;15. oDepartment of Medical Oncology, National Institute of Oncology, Budapest, Hungary;16. pDepartment of Gynecology and Obstetrics and Multidisciplinary Breast Cancer Center, Helios Klinikum, Berlin‐Buch, Germany;17. qAustralian and New Zealand Breast Cancer Trials Group, Australia;18. rCancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China;19. sDivision Hematology/Oncology Memorial Sloan‐Kettering Cancer Center, New York, New York, USA;20. tSOLTI Breast Cancer Research Group, Barcelona, Spain;21. uMayo Clinic Cancer Center, Jacksonville, Florida, USA |
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| 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. |
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| Keywords: | Activation Phase III clinical trials Ethics committee/institutional review board |
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