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Research Methods & Reporting

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c332 (Published 24 March 2010) Cite this as: BMJ 2010;340:c332

Proposed best practice for statisticians in reporting of industry-sponsored trials

We feel recently proposed best practice for statisticians in
reporting of industry-sponsored trials should be highlighted [1, 2]. The
recommendations (an abridged version of which are reproduced below), were
accompanied by two explanatory articles [3,4] which may be of interest.
We feel that the creation of a forum in which Journal Editors, industry
and academic representatives can discuss the issues raised may be
beneficial.

1. The statistical author should be responsible for the statistical
aspects of the paper

The authoring statistician should take responsibility for the
statistical content of the published report of a clinical trial.

2. The person responsible for statistical aspects of the trial should
be recognised as an author

The statistician responsible for the design, conduct, analysis and
reporting of a clinical trial should be identified and named as a co-
author of the publication.

3. Protocols should be published and/or made publicly available in a
timely manner

This will provide a means for Journal Reviewers and Editors to
confirm pre-defined study objectives, endpoints and analysis methods are
reported appropriately in the final publication.

4. Financial and other conflicts of interest should be disclosed

There should be a clear statement identifying who sponsored the
trial. Along with other co-authors, the trial statistician should declare
any financial interest and any potential conflict of interest.

5. The authors should have freedom to act

The primary investigator and other co-authors should not be
pressured, either contractually or otherwise, to suppress or delay the
publication of trial results, or to present the trial results in a manner
that they feel is inappropriate.

6. All authors should have full access to trial data

The authors of the trial manuscript should have appropriate access to
the data collected during the trial, and should have played a full part in
the interpretation of the trial results.

7. The trial results should be published

In line with legal expectation, trials should have their results
published in publicly accessible registries designed for the purpose and,
wherever possible, also in peer review journals.

8. Independent statistical review should be highlighted

If industry-sponsored clinical trials undergo a statistical review by
independent experts and/or regulators the nature and scope of review
should be described in the manuscript.

References

[1]. Matcham J, Julious S, Pyke S, O'Kelly M, Todd S, Seldrup J and
Day S. Proposed best practice for statisticians in the reporting of
industry sponsored clinical trials in medical journals. Pharmaceutical
Statistics 2010 10(1):70-73

[2]. Julious S, Matcham J, Pyke S, O'Kelly M, Todd S, Seldrup J and
Day S Highlighting recent proposed best practice for statisticians in the
reporting and publication of pharmaceutical industry sponsored clinical
trials. Journal of the European Medical Writers Association (The Write
Stuff) 2010; 19(1) 29-31

[3]. Pyke S, Julious S, Day S, O'Kelly M, Todd S, Matcham J and
Seldrup J. The potential for bias in reporting of industry sponsored
clinical trials. Pharmaceutical Statistics 2010 10(1):74-79

[4]. O'Kelly M, Julious S, Pyke S, Day S, Todd S, Seldrup J and James
Matcham. Making available information from studies sponsored by the
pharmaceutical industry: some current practices. Pharmaceutical Statistic
2010 10(1) 60-69

Competing interests: The views expressed are the author's personal views. However, they are endorsed by the Board of Statisticians in the Pharmaceutical Industry (PSI)

04 March 2011
Steven A Julious
Reader in Medical Statistics
Stephen Pyke, VP Statistics at Pfizer and Chair of the PSI and Sara Hughes, Head of Statistics at ViiV Healthcare, UK and former Chair of the PSI
University of Sheffield