Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke

Kennedy R. Lees, Pooja Khatri, Andrei V. Alexandrov, Andrew Bivard, Johannes Boltze, Joseph P. Broderick, Bruce C V Campbell, Francis M. Creighton, David Fiorella, Anthony J. Furlan, Philip B. Gorelick, David C. Hess, Won Ki Kim, Lawrence L. Latour, David S. Liebeskind, Marie Luby, Patrick Lyden, John Kylan Lynch, Randolph S. Marshall, Bijoy K. MenonKeith W. Muir, Yuko Palesch, Helen Peng, Kent E. Pryor, J. Mocco, Peter Rasmussen, Ralph L. Sacco, Lee H. Schwamm, Eric E. Smith, Yoram Solberg, Achala Vagal, Steven Warach, Lawrence R. Wechsler, Max Wintermark, Albert J. Yoo, Kay M. Zander, STAIR IX Collaborators

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Pooled analysis of individual patient data from stroke trials can deliver more precise estimates of treatment effect, enhance power to examine prespecified subgroups, and facilitate exploration of treatment-modifying influences. Analysis plans should be declared, and preferably published, before trial results are known. For pooling trials that used diverse analytic approaches, an ordinal analysis is favored, with justification for considering deaths and severe disability jointly. Because trial pooling is an incremental process, analyses should follow a sequential approach, with statistical adjustment for iterations. Updated analyses should be published when revised conclusions have a clinical implication. However, caution is recommended in declaring pooled findings that may prejudice ongoing trials, unless clinical implications are compelling. All contributing trial teams should contribute to leadership, data verification, and authorship of pooled analyses. Development work is needed to enable reliable inferences to be drawn about individual drug or device effects that contribute to a pooled analysis, versus a class effect, if the treatment strategy combines ≥2 such drugs or devices. Despite the practical challenges, pooled analyses are powerful and essential tools in interpreting clinical trial findings and advancing clinical care.

Original languageEnglish (US)
Pages (from-to)2154-2159
Number of pages6
JournalStroke
Volume47
Issue number8
DOIs
StatePublished - Aug 1 2016

Keywords

  • clinical trial
  • meta-analysis as topic
  • randomized controlled trial
  • stroke

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

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