Document Detail

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.
MedLine Citation:
PMID:  23359433     Owner:  NLM     Status:  MEDLINE    
PURPOSE: This study measured the time taken for setting up the different facets of adjuvant lapatinib and/or trastuzumab treatment optimization (ALTTO), an nternational 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.
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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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-01-28
Journal Detail:
Title:  The oncologist     Volume:  18     ISSN:  1549-490X     ISO Abbreviation:  Oncologist     Publication Date:  2013  
Date Detail:
Created Date:  2013-02-25     Completed Date:  2013-12-12     Revised Date:  2014-02-04    
Medline Journal Info:
Nlm Unique ID:  9607837     Medline TA:  Oncologist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  134-40     Citation Subset:  IM    
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MeSH Terms
Antibodies, Monoclonal, Humanized / administration & dosage,  therapeutic use*
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Breast Neoplasms / drug therapy*,  pathology
Clinical Trials, Phase III as Topic / methods*
International Cooperation
Multicenter Studies as Topic / methods*
Quinazolines / administration & dosage
Randomized Controlled Trials as Topic / methods*
Time Factors
Reg. No./Substance:
0/Antibodies, Monoclonal, Humanized; 0/Quinazolines; 0VUA21238F/lapatinib; P188ANX8CK/trastuzumab
Comment In:
Nat Rev Clin Oncol. 2013 Mar;10(3):121   [PMID:  23399999 ]

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