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

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

Research output: Contribution to journalArticle

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: 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.

Original languageEnglish (US)
Pages (from-to)134-140
Number of pages7
JournalOncologist
Volume18
Issue number2
DOIs
StatePublished - 2013

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Phase III Clinical Trials
Breast Neoplasms
Ethics Committees
Research Ethics Committees
Therapeutics
Trastuzumab
TimeLine
lapatinib
Investigational Therapies
Time and Motion Studies
South America
United Nations
Drug Industry
North America
Research
Economics
Efficiency

Keywords

  • Activation
  • Ethics committee/institutional review board
  • Phase III clinical trials

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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. / Metzger-Filho, Otto; de Azambuja, Evandro; Bradbury, Ian; Saini, Kamal S.; Bines, José; Simon, Sergio D.; van Dooren, Veerle; Aktan, Gursel; Pritchard, Kathleen I.; Wolff, Antonio C; Smith, Ian; Jackisch, Christian; Lang, Istvan; Untch, Michael; Boyle, Frances; Xu, Binghe; Baselga, Jose; Perez, Edith A.; Piccart-Gebhart, Martine.

In: Oncologist, Vol. 18, No. 2, 2013, p. 134-140.

Research output: Contribution to journalArticle

Metzger-Filho, O, de Azambuja, E, Bradbury, I, Saini, KS, Bines, J, Simon, SD, van Dooren, V, Aktan, G, Pritchard, KI, Wolff, AC, Smith, I, Jackisch, C, Lang, I, Untch, M, Boyle, F, Xu, B, Baselga, J, Perez, EA & Piccart-Gebhart, M 2013, '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', Oncologist, vol. 18, no. 2, pp. 134-140. https://doi.org/10.1634/theoncologist.2012-0342
Metzger-Filho, Otto ; de Azambuja, Evandro ; Bradbury, Ian ; Saini, Kamal S. ; Bines, José ; Simon, Sergio D. ; van Dooren, Veerle ; Aktan, Gursel ; Pritchard, Kathleen I. ; Wolff, Antonio C ; Smith, Ian ; Jackisch, Christian ; Lang, Istvan ; Untch, Michael ; Boyle, Frances ; Xu, Binghe ; Baselga, Jose ; Perez, Edith A. ; Piccart-Gebhart, Martine. / 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. In: Oncologist. 2013 ; Vol. 18, No. 2. pp. 134-140.
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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: 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.",
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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.

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