TY - JOUR
T1 - Analysis of regional timelines to set up a global phase III clinical trial in breast cancer
T2 - The adjuvant lapatinib and/or trastuzumab treatment optimization experience
AU - Metzger-Filho, Otto
AU - de Azambuja, Evandro
AU - Bradbury, Ian
AU - Saini, Kamal S.
AU - Bines, José
AU - Simon, Sergio D.
AU - van Dooren, Veerle
AU - Aktan, Gursel
AU - Pritchard, Kathleen I.
AU - Wolff, Antonio C.
AU - Smith, Ian
AU - Jackisch, Christian
AU - Lang, Istvan
AU - Untch, Michael
AU - Boyle, Frances
AU - Xu, Binghe
AU - Baselga, Jose
AU - Perez, Edith A.
AU - Piccart-Gebhart, Martine
PY - 2013
Y1 - 2013
N2 - 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: 26days, range:22-30days),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. Thiswould enable faster access of patients to innovative therapies and enhance the efficiency of clinical research.
AB - 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: 26days, range:22-30days),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. Thiswould enable faster access of patients to innovative therapies and enhance the efficiency of clinical research.
KW - Activation
KW - Ethics committee/institutional review board
KW - Phase III clinical trials
UR - http://www.scopus.com/inward/record.url?scp=84874350918&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84874350918&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2012-0342
DO - 10.1634/theoncologist.2012-0342
M3 - Review article
C2 - 23359433
AN - SCOPUS:84874350918
SN - 1083-7159
VL - 18
SP - 134
EP - 140
JO - Oncologist
JF - Oncologist
IS - 2
ER -