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QSPI Multiplicity Working Group

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The multiplicity working group was created in Summer 2012 to provide general information on traditional and innovative approaches to the design and analysis of clinical trials with multiple objectives and facilitate widespread use of efficient statistical methods for addressing multiplicity issues.

The working group is sponsored by the industry group QSPI (Quantitative Sciences in the Pharmaceutical Industry) operating as part of the Society for Clinical Trials. The working group is chaired by Alex Dmitrienko (Quintiles).

Current members

Gary Aras (Amgen), Thomas Brechenmacher (Novartis), Carl-Fredrik Burman (AstraZeneca), Christy Chuang-Stein (Pfizer), David Dorey (GlaxoSmithKline), Olivier Guilbaud (AstraZeneca), Vincent Haddad (Amgen), Patrick Huang (Takeda), James Hung (US Food and Drug Administration), Vishwanath Iyer (Novartis), James Lancaster (Abbott), David Li (Pfizer), Pilar Lim (Johnson & Johnson), Franz Koenig (Medical University of Vienna), George Kordzakhia (US Food and Drug Administration), Alok Krishen (GlaxoSmithKline), Haihong Li (Vertex), Ilya Lipkovich (Quintiles), Jeff Maca (Quintiles), Olga Marchenko (Quintiles), Devan Mehrotra (Merck), Brian Millen (Lilly), Walter Offen (Abbott), Gautier Paux (Servier), Alan Phillips (ICON), Yili Pritchett (Astellas), Hui Quan (Sanofi), AJ Sankoh (Vertex), Yevgen Tymofyeyev (Johnson & Johnson), Bushi Wang (Boehringer Ingelheim), Huei Wang (Amgen), Brian Wiens (Alcon/Novartis), Jerry Wang (BMS), Sue-Jane Wang (US Food and Drug Administration), Haiyan Xu (Johnson & Johnson), Bin Yao (Puma Biotechnology).

Initiatives

CHMP concept paper

A subteam within the working group put together a detailed set of comments on the CHMP concept paper on the need for a guideline on multiplicity issues in clinical trials released in May 2012 (see Regulatory Guidance). The final comments were submitted to the Biostatistics Working Party at the European Medicines Agency in August 2012.

Subteam on subgroup analysis in clinical trials

A subteam was created within the working group in Fall 2012 to focus on issues related to subgroup analysis and subgroup identification in clinical trials. The subteam is chaired by Ilya Lipkovich (Quintiles). For more information, see QSPI Subgroup Analysis Subteam.

Lecture series

An online lecture series on key multiplicity issues in clinical drug development was created in Fall 2012. Jeff Maca (Quintiles) chairs the online lecture series. For more information, see QSPI Multiplicity Lecture Series.