History
How it began
In the early 1990s, there was increasing evidence that reports of clinical trials were often missing critical information, preventing readers from fully critically evaluating and using the findings. Efforts to tackle poor reporting led to the independent development of two trial reporting guidelines in 1994: the Standards of Reporting Trials (SORT) Statement, and the Alisomar guidelines from the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. The groups behind these initiatives subsequently collaborated to produce the CONSORT (CONsolidated Standards Of Reporting Trials) Statement first published in 1996, revised in 2001 and then in 2010, along with a CONSORT Explanation and Elaboration document that explained and illustrated the principles underlying the statement.
David Moher (left), Ken Schulz (right) and Doug Altman (front) at the CONSORT Group Meeting in Montebello, Canada, September 2011
Evidence of similar lack of complete and transparent reporting in clinical trial protocols led to the launch of the SPIRIT initiative in 2007, and subsequent publication of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement and its accompanying Explanation and Elaboration document.
Timeline of SPIRIT and CONSORT
How it remains relevant
In 2020, the SPIRIT and CONSORT Executive groups merged to lead a concurrent update of SPIRIT and CONSORT to be published in 2025. The updated guidelines followed established methodology involving evidence-based recommendations and expert consensus. Updating the checklists together also allows alignment of the content, providing consistent guidance on reporting a trial through its life-cycle, from design to results.
Past SPIRIT and CONSORT Groups
We gratefully acknowledge the important contributions of the following individuals to the development of SPIRIT and CONSORT over the years:
2014 - CONSORT
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Doug Altman, Virginia Barbour, Isabelle Boutron, Marion Campbell, An-Wen Chan, Erik Cobo, Taddy Dickersin, Paul Glasziou, Rob Golub, Jeremy Grimshaw, Trish Groves, Sally Hopewell, John Ioannidis, David Moher, Cindy Mulrow, Nikoloas Pandis, Philippe Ravaud, Drummond Rennie, Jason Roberts, Joseph Ross, David Schriger, Ken Schulz, Larissa Shamseer, Daniel Shanahan, Ida Sim, Iveta Simera
2013 - SPIRIT
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An-Wen Chan (Chair), Douglas Altman, Jesse Berlin, Kay Dickersin, Caroline Doré, Geneviève Dubois-Flynn, Peter Gøtzsche, Trish Groves, Asbjørn Hróbjartsson, Karmela Krleža-Jerić, Andreas Laupacis, Howard Mann, David Moher, Wendy Parulekar, Drummond Rennie, Frank Rockhold, Kenneth Schulz, Harold Sox, William Summerskill, Jennifer Tetzlaff, Ashley Lau (Staff)
2011 - CONSORT
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Rakesh Aggarwal, Doug Altman, Virginia Barbour, Jesse Berlin, Zhao-xiang Bian, Isabelle Boutron, An-Wen Chan, P.J. Devereaux, Taddy Dickersin, Diana Elbourne, Dean Fergusson, Brad Glazer, Paul Glasziou, Peter Gøtzsche, David Grimes, Jeremy Grimshaw, Trish Groves, Sally Hopewell, Ian Hrynaszkiewicz, David Moher, Victor Montori, Cindy Mulrow, Martin Offringa, Philippe Ravaud, David Sackett, David Schriger, Ken Schulz, Larissa Shamseer, Nandi Siegfried, Bill Summerskill, Thang Tran
2007 - CONSORT
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Doug Altman, Virginia Barbour, Jesse Berlin, Isabelle Boutron, Mike Clarke, P.J. Devereaux, Kay Dickersin, Diana Elbourne, Susan Ellenberg, Val Gebski, Steven Goodman, Peter Gøtzsche, Jeremy Grimshaw, Trish Groves, Steven Grunberg, Gordon Guyatt, Brian Haynes, Sally Hopewell, Astrid James, Peter Juhn, Philippa Middleton, Don Minckler, David Moher, Victor Montori, Cynthia Mulrow, Stuart Pocock, Drummond Rennie, David Schriger, Kenneth F. Schulz, Iveta Simera, Liz Wager
2004 - CONSORT
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Doug Altman, Matthias Egger, Diana Elbourne, Stephen Evans, Joel Gagnier, Peter Gøtzsche, Tom Lang, Yoon Kong Loke, David Moher, Drummond Rennie, David Riley, David Sackett, Roberta Scherer, Ken Schulz
2001 - CONSORT
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Doug Altman, Patrick Bossuyt, Frank Davidoff, Matthias Egger, Peter Gøtzsche, Delphine Grynzspan, Barbara Hawkins, Richard Horton, John Ioannidis, Jeroen Lijmer, Howard Mann, David Moher, Drummond Rennie, Kenneth F. Schulz
2000 - CONSORT
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Douglas Altman, Frank Davidoff, Susan Eastwood, Matthias Egger, Diana Elbourne, Peter Gøtzsche, Sylvan B. Green, Leni Grossman, Richard Horton, Wayne B. Jonas, Thomas Lang, Jeroen Lijmer, Richard Malone, Curtis L. Meinert, David Moher, Mary Mosley, Stuart Pocock, David Riley, Roberta W. Scherer, Kenneth F. Schulz, Ida Sim, Donna F. Stroup
1999 - CONSORT
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Doug Altman, Frank Davidoff, Matthias Egger, Diana Elbourne, Peter Gøtzsche, Sylvan B. Green, Barbara Hawkins, Richard Horton, Terry Klassen, Thomas Lang, Curtis L. Meinert, David Moher, Drummond Rennie, Kenneth F. Schulz
1999 - CONSORT
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Colin Begg, Mildred Cho, Susan Eastwood, Richard Horton, David Moher, Ingram Olkin, Roy Pitkin, Drummond Rennie, Kenneth F. Schulz, David Simel, Donna Stroup