Clinical Trial Report

A guide for authors submitting to the Expert Collection

Word limit: The word limit for Clinical Trial Reports is 3,000-7,000 words (not including tables, figures and references).

Aim: The aim of a Clinical Trial Report is to provide a concise review of the rationale, design and results of a specific clinical trial (or clinical trial program). Authors are encouraged to provide a critical appraisal of the most important and up-to-date information and provide their own viewpoint on the implications of the study on clinical practice.

Timing: Several factors contribute to the selection of drugs to be reviewed, including scientific need, emergence of new important clinical data, market launches, approval of new indications, and the requirement for an alternative appraisal of the literature. Timing is critical and it is important that the deadlines set by the Commissioning 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 Profiles Editor will be happy to accommodate such requests.

Every article must contain:

Title: Should be concise but informative, including the drug and therapeutic indication. Titles should not contain brand names

Authors’ names and addresses: Including address, academic qualifications and job titles of all authors, as well as telephone number, fax number and email address of the author for correspondence on a separate cover sheet as the peer reviewers will be blinded to 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.

Summary (maximum 150 words): 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.

  • 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.

Introduction: Incorporating basic information on disease incidence and prevalence, unmet medical need and present treatment guidelines (highlighting regional variations where appropriate).

Introduction to the trial:

    • Background and rationale
    • Design
    • Data analysis
    • Results
    • Safety and tolerability
    • Conclusion: An analysis of the data presented in the review.

Expert commentary: To distinguish reviews published in the series of journals, authors must provide an additional section entitled Expert commentary. This section affords authors the opportunity to go beyond the conclusion and provide their interpretation of the data presented in the article, discussing implications for disease management and clinical practice and the impact on regulatory filings and treatment guidelines. In addition there is the opportunity to discuss the developments that are likely to be important in the future and the avenues of research likely to become exciting as further studies yield more detailed results.

Five-year view: Authors are challenged to include a speculative viewpoint on how the field will have evolved 5 years from the point at which the review was written.

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

Information resources: A brief summary to direct the reader to the most important further reading, related articles and relevant websites.

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).