Clinical Trial Evaluation

expert-opinion-logoScope: The aim of Clinical Trial Evaluations is to evaluate the quality of design and implementation of a pivotal study. The author should provide a balanced and contextualised discussion of the trial and its results and not simply summarise the original publication.

Word limit: The word limit for Clinical Trial Evaluations is 1,000-1,500 words (not including figures, tables or references).

Every article must contain:

Title: All article types should have a concise, informative title that contains no brand names. Titles should be impartial and non-promotional.

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 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.

Abstract (maximum 200 words)
Body of the article

  • Introduction: The paper under discussion must be introduced and referenced as Reference [1]. The trial number must also be provided if available. The rationale behind the study should be presented, placing it in context with previous studies using the drug and indicating the relative importance of this new work.
  • Study design: Describe and discuss the quality and appropriateness of the trial design. What were the primary objectives, selection criteria, treatment plan, number of participants, trial locations, etc? Was this appropriate? Were there any limitations to the study?
  • Key results: Briefly summarise the key results from the study in a bulleted list and comment on their significance.

Expert opinion (200-500 words)
To distinguish the articles published in the Expert opinion series, authors must provide an additional section entitled ‘Expert opinion’. Give your opinion on what the success factors were in this study:

  • Can anything be learned from it for future studies?
  • How will the results be received by medical professionals?
  • What will the impact of this study be on the future of this drug or the therapy area as a whole?

Comparative assessment is encouraged and related trials may be referenced.