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Guide to Performing Peer Review for Clinical Trial Protocol Articles

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Guide to Performing Peer Review for Clinical Trial Protocol Articles 1 Version: 26th November 2020 Guide to Performing Peer Review for Clinical Trial Protocol Articles This document outlines how to perform peer review on Clinical Trial Protocols. We recommend you read the Guide to Performing Peer Review in addition to this document. All Future Science Group journals process article submissions via ScholarOne Manuscripts. For detailed user guides, video tutorials and more from ScholarOne Manuscripts, please visit the website here: mchelp.manuscriptcentral.com/gethelpnow/training/reviewer/ Contents What is a Clinical Trial Protocol? ............................................................................................................. 2 Typical layout and sections ..................................................................................................................... 2 Reviewing a Clinical Trial Protocol .......................................................................................................... 2 What to do if you have serious concerns? .............................................................................................. 3 Submitting a Clinical Trial Protocol ......................................................................................................... 4 Available tools & resources..................................................................................................................... 4 Future Science Ltd and Newlands Press Ltd, Unitec House, 2 Albert Place, London, N3 1QB, UK; T: +44 (0)20 8371 6090; www.future-science.com Future Science Ltd is part of the Future Science Group www.future-science-group.com 2 Version: 26th November 2020 What is a Clinical Trial Protocol? The aim of a Clinical Trial Protocol is to provide a concise review outlining the rationale and design of a planned trial or cluster/program of studies. Authors are encouraged to discuss the implications of the study’s results on clinical practice. Authors should restrict their discussion to the indication investigated in the trials. Please note that a Clinical Trial Protocol discusses an ongoing study, for which no results are available. Clinical Trial Protocols are vital in helping clinicians to keep up with ongoing trials in their field and provide an important reference during the final publication of the results. Typical layout and sections 1) Abstract: Not more than 120 words; no references should be cited in the abstract. The abstract should highlight the importance of the field under discussion within the journal’s scope, and clearly define the parameters of the article. The clinical trial registration number should be included at the end of the abstract, where available. 2) Keywords: Up to 10 keywords (including therapeutic area, mechanism[s] of action etc.) plus names of drugs, devices and vaccines mentioned in the text. 3) Introduction: Incorporating basic information on disease incidence and prevalence, unmet medical need and present management guidelines (highlighting regional variations where appropriate). 4) Body of the article: The article content should be arranged under relevant headings and subheadings to assist the reader. Where available the clinical trial registration number should be included on the first mention of the trial in the main body of text. Mention of other trials should also include the relevant registration number, where available. a) Introduction to the trial: Should introduce the trial, giving the full trial title and acronym (if applicable), sponsor information, clinical phase and the product(s) under investigation. If a trial registration number is available, this should be included where appropriate. b) Design: Study design, eligibility criteria, planned sample size, planned study period, study procedures, outcome measures/end points, statistics (if applicable). c) Conclusion: Concluding remarks on the information presented in the review. 5) Executive summary: A series of bulleted summary points that illustrate the main topics or conclusions made under each of the main headings of the article. 6) References and reference annotations. Please see the below links for some examples of previously published Clinical Trial Protocols: . https://www.futuremedicine.com/doi/10.2217/fon-2017-0619 . https://www.futuremedicine.com/doi/10.2217/rme-2017-0032 . https://www.futuremedicine.com/doi/10.2217/fmb-2019-0332 . https://www.futuremedicine.com/doi/10.2217/nmt-2017-0024 Reviewing a Clinical Trial Protocol We welcome feedback in any form and are very grateful for the time you have taken to review this manuscript. Please remember that authors can usually change very little about the actual protocol Future Science Ltd and Newlands Press Ltd, Unitec House, 2 Albert Place, London, N3 1QB, UK; T: +44 (0)20 8371 6090; www.future-science.com Future Science Ltd is part of the Future Science Group www.future-science-group.com 3 Version: 26th November 2020 itself, they can only modify how It is presented. In order that your comments can be of greatest use to authors, please consider commenting on the following points when submitting your review: 1) Are all the relevant sections, as outlined above, included in the manuscript? 2) Have the authors provided sufficient detail on the trial and the general area that they are investigating or are there issues that you believe they should discuss further? 3) Is the manuscript well written? The English and grammar should be of a high standard and the paper should flow well. 4) Are the Figures and Tables clear, with legends? Perhaps there are particular Figures and Tables you think would improve the paper? 5) Would the paper benefit from the inclusion of certain references that the authors have not mentioned? While each reviewer leaves a unique set of comments, some make it significantly easier for the Editor to make an informed decision on the status of the paper. Please see below for an example of a good review, printed here with permission from the reviewer: The authors describe an ongoing phase IIIb trial of olaparib in patients with platinum sensitive recurrent BRCA wildtype ovarian cancer. The manuscript is well written with excellent description of the planned protocol and objectives. There are only a few revisions/clarifications that are necessary to make this acceptable for publication. 1. The description of the mechanism of action of PARP is incomplete. The authors only note PARP trapping. A discussion of synthetic lethality and the push toward NHEJ should be mentioned. 2. Page 5 Line 55 - Page 6 Line 1-5. The statement regarding Study 19 notes that there was an overall survival benefit. This was not a statistically significant difference and it should be noted in this manuscript that this was a trend 3. Page 6 Lines 28-35. The comment that HRD has not been able to predict patients that respond to PARP inhibition is not quite true. There is still an impact in HRD patients, just not as profound as in BRCA mutant patients. This should be clarified. 4. Please clarify why BRCA somatic mutations are not excluded from this trial. There have been multiple studies that have demonstrated benefit in this population. What to do if you have serious concerns? If you believe there is an issue with the manuscript that needs immediate attention, please contact the journal editor or email Julia Titova ([email protected]). This includes, but is not limited to, the following issues: . The manuscript has not been blinded and contains the names of authors or their affiliations. You suspect the manuscript has been plagiarised. You believe the study is unethical (if you have concerns regarding this, please see our “Ethical conduct of research” section). Future Science Ltd and Newlands Press Ltd, Unitec House, 2 Albert Place, London, N3 1QB, UK; T: +44 (0)20 8371 6090; www.future-science.com Future Science Ltd is part of the Future Science Group www.future-science-group.com 4 Version: 26th November 2020 Submitting a Clinical Trial Protocol We hope that you have enjoyed reviewing this clinical trial protocol. All Future Medicine journals consider unsolicited manuscript proposals and if you would like to submit a manuscript, we would be happy to discuss this would you. Please do reach out to the relevant journal editor or Johanna Todd ([email protected]), who would be happy to answer your queries. Available tools & resources Guide to Performing Peer Review o Guide to Performing Peer Review https://www.future-science.com/pb- assets/Guidelines%20for%20Peer%20Reviewers_FS%20&%20NL.pdf Publons Academy o Publons provides a free peer review training course, available here: https://publons.com/community/academy/ Methods reporting standards o Future Medicine Methods Reporting Checklist for Authors: https://www.future- science.com/authorguide/preparingyourarticle Committee on Publication Ethics (COPE): https://publicationethics.org/ o COPE Ethical Guidelines for Peer Reviewers: https://publicationethics.org/resources/guidelines-new/cope-ethical-guidelines- peer-reviewers Diagnostic accuracy studies o Standards for Reporting of Diagnostic Accuracy (STARD) checklist/flowchart: https://www.equator-network.org/reporting-guidelines/stard/ Observational research studies o Strengthening the reporting of observational studies (STROBE) checklist/flowchart: https://www.strobe-statement.org/index.php?id=available-checklists Systematic reviews and meta-analyses o PRISMA checklist/flowchart: http://www.prisma-statement.org/PRISMAStatement/ Randomized controlled trials o Consolidated Standards of Reporting Trials (CONSORT) checklist/flowchart: www.consort-statement.org/ Future Science Ltd and Newlands Press Ltd, Unitec House, 2 Albert Place, London, N3 1QB, UK; T: +44 (0)20 8371 6090; www.future-science.com Future Science Ltd is part of the Future Science Group www.future-science-group.com .
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