Clinical trials describe the methodology, implementation and results of controlled studies, usually undertaken with large patient groups. These trials are used to test whether a treatment is safe and effective, and their accurate reporting is essential to clinical research and practice. The reviewer plays a crucial role in the process, ensuring that published articles contain reliable and ethically sound research and analysis.
When reviewing a paper you should:
- Outline the relative strengths or weaknesses of the paper
- Offer constructive feedback
- Remember that a referee may disagree with the author’s opinions, but should allow them to stand, provided they are consistent with the available evidence.
Step one: Answer general questions
The main factors you should provide advice on as a reviewer are the originality, presentation, relevance, and significance of the manuscript’s subject matter to the readership of the journal. Try to have the following questions in mind when you are reading the manuscript:
Quality and value
- Is the submission original?
- Is the research cutting edge or topical?
- Is the research sound and evidenced?
- Does it help to expand or further research in this subject area?
- Does it significantly build on previous work?
- Do you feel that the significance and potential impact of the paper is high or low?
- Does the paper fit the scope of the journal?
- Would the paper be of interest to the readership of the journal?
- If not, would you recommend that the author reconsiders the paper for a related or alternative journal?
- Should it be shortened and reconsidered in another form? Each paper should be of the shortest length required to contain all useful and relevant information, and no longer.
- Is the writing style clear and appropriate to the readership? For non-native speakers, Taylor & Francis offers English language editing services.
- Are all relevant accompanying data, citations, or references given by the author? Are any tables or graphics clear to read and labeled appropriately?
- Does the paper contain the appropriate referencing to provide adequate context for the present work?
Step two: Assess clinical quality
In addition to being a sound and original academic article, the paper should also conform to clinical standards and ethical guidelines. Does the paper contain the following sections:
Title: Is this a concise, comprehensive, and clear description of the study undertaken?
Abstract: This should fully describe the trial, demographics, setting, methods, results, limitations, and conclusions. Are both efficacy and adverse effects summarized in sufficient detail and balance?
Introduction: Does this include full, properly referenced background information, relevance, and rationale for conducting the study? Does it conclude with a clear statement of objectives?
Patients and methods: If applicable, sufficient detail on the following should be provided: study population, setting, selection process, randomization, blinding, efficacy/safety/vital signs/compliance measures (and by whom), databases/search methods, ethical approval, patient consent, and statistical methods.
Trial registration number: Has the trial been registered in a public repository at the beginning of the research process (prior to patient enrollment)?
Ethical considerations: Has all research been conducted in an ethical and responsible manner? Does the paper include a statement of approval from a formal ethics review committee, or compliance with the appropriate ethical principles for the region (e.g. Declaration of Helsinki)?
Results: Are results presented clearly and concisely with sufficient tables and figures, using both numbers and percentages? Are both efficacy and adverse events provided in sufficient amount and detail? Are there comments here that belong instead to the discussion section?
Discussion: Are implications/conclusions/extrapolations reasonable and adequately supported by the results? Are efficacy and adverse results discussed in sufficient detail and balance? Are limitations and discussion of other relevant studies adequately described? Are any other alternatives possible? Does this include a recommendation for future research?
Conclusion: Does it concisely summarize (without over-extrapolation) all results and clinical implications?
Step three: Make a recommendation
Once you’ve read the paper and have assessed its quality, you need to make a recommendation to the editor regarding publication. The specific decision types used by a journal may vary, but the key decisions are:
- Accept – if the paper is suitable for publication in its current form.
- Minor revision – if the paper will be ready for publication after light revisions. Please list the revisions you would recommend the author makes.
- Major revision – if the paper would benefit from substantial changes such as expanded data analysis, widening of the literature review, or rewriting sections of the text.
- Reject – if the paper is not suitable for publication with this journal, or if the revisions that would need to be undertaken are too fundamental for the submission to continue being considered in its current form.
Step four: Provide detailed comments
- These should be suitable for transmission to the authors: use the comment to the author as an opportunity to seek clarification on any unclear points and for further elaboration.
- If you have time, make suggestions as to how the author can improve clarity, succinctness, and the overall quality of presentation.
- Confirm whether you feel the subject of the paper is sufficiently interesting to justify its length; if you recommend shortening, it is useful to the author(s) if you can indicate specific areas where you think that shortening is required.
- It is not the job of the reviewer to edit the paper for English, but it is helpful if you suggest corrections to the English where the technical meaning is unclear.
- Being critical whilst remaining sensitive to the author isn’t always easy, and comments should be carefully constructed so that the author fully understands what actions they need to take to improve their paper. For example, generalized or vague statements should be avoided, along with any negative comments which aren’t relevant or constructive.