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

被引:22
|
作者
Metzger-Filho, Otto [1 ,2 ,3 ]
de Azambuja, Evandro [2 ,3 ,4 ]
Bradbury, Ian
Saini, Kamal S. [2 ,5 ]
Bines, Jose [6 ,7 ]
Simon, Sergio D. [6 ,8 ]
Van Dooren, Veerle [3 ]
Aktan, Gursel [9 ]
Pritchard, Kathleen I. [10 ]
Wolff, Antonio C. [11 ]
Smith, Ian [12 ,13 ]
Jackisch, Christian
Lang, Istvan [14 ]
Untch, Michael [15 ,16 ]
Boyle, Frances
Xu, Binghe [17 ]
Baselga, Jose [18 ,19 ]
Perez, Edith A. [20 ]
Piccart-Gebhart, Martine [2 ,3 ,4 ,5 ]
机构
[1] Dana Farber Canc Inst, Div Womens Canc, Boston, MA 02215 USA
[2] Univ Libre Brussels, Brussels, Belgium
[3] Breast European Adjuvant Study Team BrEAST Data C, Brussels, Belgium
[4] Inst Jules Bordet, Dept Med Oncol, B-1000 Brussels, Belgium
[5] Breast Int Grp, Brussels, Belgium
[6] Grp Brasileiro Estudos Canc Mama GBECAM Sao Paulo, Sao Paulo, Brazil
[7] INCA, Inst Nacl Canc, Rio De Janeiro, Brazil
[8] Univ Fed Sao Paulo, Dept Oncol Clin, Sao Paulo, Brazil
[9] GlaxoSmithKline, Collegeville, PA USA
[10] Univ Toronto, Sunnybrook Odette Canc Ctr, Toronto, ON, Canada
[11] Johns Hopkins Kimmel Comprehens Canc Ctr, Dept Oncol, Baltimore, MD USA
[12] Royal Marsden Hosp, Breast Unit, London SW3 6JJ, England
[13] Inst Canc Res, London SW3 6JB, England
[14] Natl Inst Oncol, Dept Med Oncol, Budapest, Hungary
[15] HELIOS Klin, Dept Gynecol & Obstet, Berlin, Germany
[16] HELIOS Klin, Multidisciplinary Breast Canc Ctr, Berlin, Germany
[17] Chinese Acad Med Sci, Canc Inst & Hosp, Beijing 100730, Peoples R China
[18] Mem Sloan Kettering Canc Ctr, Div Hematol Oncol, New York, NY 10021 USA
[19] SOLTI Breast Canc Res Grp, Barcelona, Spain
[20] Mayo Clin, Ctr Canc, Jacksonville, FL 32224 USA
来源
ONCOLOGIST | 2013年 / 18卷 / 02期
关键词
Activation; Phase III clinical trials; Ethics committee/institutional review board;
D O I
10.1634/theoncologist.2012-0342
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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
引用
收藏
页码:134 / 140
页数:7
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