Clinical trial protocol

A protocol for authors submitting to the Expert Collection

Word limit

The word limit for Clinical Trial protocols is 2000–4000 words (not including abstract, article highlights, references & figure/table legends).

Aim

The aim of a Clinical Trial protocol is to provide a concise review outlining the rationale and design of an ongoing trial (providing patient recruitment has not been completed at the time of submission) or cluster/program of studies. Authors are encouraged to discuss the implications of the study’s results on clinical practice. Clinical Trial Protocols undergo external peer review. Reporting should follow the SPIRIT criteria. A summary of required sections is provided below, but further information on these should be taken from the SPIRIT checklist. In addition, a completed SPIRIT checklist should be provided as Supplementary Material on submission of the article.

Focus

Authors should restrict their discussion to the indication investigated in the trials.

Timing

Trials are selected to be reviewed based on their relevance to the journal’s audience and the potential implications of their findings to the field. Thus, timing is critical and it is important that the deadlines set by the Editor are met. However, if you feel there is a need to delay publication, for instance to discuss new data presented at a scientific meeting or to coincide with the publication of primary literature, the Editor will be happy to accommodate such requests.

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Every article must contain

Title

All article types should have a concise, informative title.

Title page

Authors’ names and affiliation: Including address, academic qualifications and job titles of all authors, as well as telephone number and email address of the author for correspondence on a separate cover sheet as the peer reviewers will not be aware of the authors’ identity.

Please note that only the address of the first author of the article will appear on Medline/PubMed, not necessarily the corresponding author.

Abstract

Maximum 200 words.

The aim of the abstract is to draw in the interested reader and provide an accurate reflection of the content of the paper. No references should be cited in the summary.

The role of the summary is to draw in the interested casual browser. This should not be an abstract but should outline the article scope and briefly put it into context. No references should be cited in the summary.

Plain language summary (optional)

Maximum 250 words.

Keywords

A brief list of keywords, in alphabetical order, is required to assist indexers in cross-referencing. The keywords will encompass the therapeutic area, mechanism(s) of action, key compounds etc.

Article highlights

An executive summary of the authors’ main points (bulleted) is very useful for time-constrained readers requiring a rapidly accessible overview.

Body of article

*please refer to body of article structure at the bottom of the page

References

Target of approximately 50 references.

Annotated bibliography

Important references should be highlighted with a one/two star system and brief annotations should be given (see the journal Information for Authors page for examples and for a more detailed description of our referencing style).

Body of article

  • Introduction

    • Background and rationale
    • Objectives
    • Trial design

  • Methods

    • Study setting
    • Eligibility criteria
    • Interventions
    • Outcomes
    • Participant timeline
    • Sample size
    • Recruitment

  • Methods: Assignment of interventions (for controlled trials only)

    • Sequence generation
    • Allocation concealment mechanism
    • Implementation
    • Masking

  • Methods: Data collection, management and analysis

    • Data collection methods
    • Data management
    • Statistical methods

  • Methods: Monitoring

    • Data monitoring
    • Harms
    • Auditing

  • Ethics and dissemination

  • Conclusion