Clinical Trials
Manuscript Submission Guidelines:
This Journal is a member of the Committee on Publication Ethics
This Journal recommends that authors follow the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals formulated by the International Committee of Medical Journal Editors (ICMJE).
Please read the guidelines below then visit the Journal’s submission site http://mc.manuscriptcentral.com/clinicaltrials to upload your manuscript. Please note that manuscripts not conforming to these guidelines may be returned.
Only manuscripts of sufficient quality that meet the aims and scope of Clinical Trials will be reviewed.
There are no fees payable to submit or publish in this journal.
As part of the submission process you will be required to warrant that you are submitting your original work, that you have the rights in the work, and that you have obtained and can supply all necessary permissions for the reproduction of any copyright works not owned by you, that you are submitting the work for first publication in the Journal and that it is not being considered for publication elsewhere and has not already been published elsewhere. Please see our guidelines on prior publication and note that Clinical Trials does not accept submissions of papers that have been posted on pre-print servers.
If you have any questions about publishing with SAGE, please visit the SAGE Journal Solutions Portal
1. What do we publish?
1.1 Aims & Scope
Before submitting your manuscript to Clinical Trials, please ensure you have read the Aims & Scope.
Clinical Trials is an international peer reviewed scholarly journal that addresses topics of interest to individuals involved in the design and conduct of clinical trials. The primary aim is the dissemination of generalizable knowledge about the design, conduct, analysis, synthesis, history, ethics, regulation and clinical or policy impact of all types of clinical trials. Topics that fall within the aims and scope of Clinical Trials include data management, trial logistics, design and conduct of trials, statistical methods, impact of trials on practice and policy, ethics, law and regulation, synthesis and evidence evaluation, history, education and training, patient-related issues, decision analysis, and commentaries on current or controversial issues in clinical trials. The journal does not publish articles that essentially reproduce the protocol for an individual clinical trial. Articles that simply report the results of a completed clinical trial are also not considered, unless the trial is evaluating or comparing methodologic innovations.
1.2 Article Types
The editor of Clinical Trials: Journal of the Society for Clinical Trials will consider manuscripts containing original material providing neither the article nor any part of its essential substance, tables, or figures has been or will be published or is currently submitted elsewhere other than Clinical Trials. This restriction does not apply to abstracts published in connection with scientific meetings.
In addition to original research papers (maximum 4,000 words excepting abstract, references, tables and figures; maximum 6 tables or figures), Clinical Trials also welcomes Short Communications (manuscripts of 2000 or fewer words, excepting references, tables and figures; maximum 3 tables/figures), Research Letters (1000 or fewer words, 12 or fewer references, 1 table or figure) and letters to the Editor (500 or fewer words) for possible publication. Submissions exceeding the word limits will be “un-submitted” and returned without review to the corresponding author. Note that it is possible to publish additional material as supplementary text, tables and/or figure, but such material may not be reviewed carefully and its content is the responsibility of the author.
1.3 Writing your paper
The SAGE Author Gateway has some general advice and on how to get published, plus links to further resources.
1.3.1 Make your article discoverable
When writing up your paper, think about how you can make it discoverable. The title, keywords and abstract are key to ensuring readers find your article through search engines such as Google. For information and guidance on how best to title your article, write your abstract and select your keywords, have a look at this page on the Gateway: How to Help Readers Find Your Article Online.
2. Editorial policies
2.1 Peer review policy
The journal's policy is to obtain at least two independent reviews of each article under serious consideration for publication. It operates a reviewing policy in which the reviewer’s name is always concealed from the submitting author. Referees are encouraged to provide substantive, constructive reviews that provide suggestions for improving the work and distinguish between mandatory and non-mandatory recommendations.
All manuscripts accepted for publication are subject to editing for presentation, style and grammar. Any major redrafting is agreed with the author but the Editor's decision on the text is final.
As part of the submission process you will be asked to provide the names of peers who could be called upon to review your manuscript. Recommended reviewers should be experts in their fields and should be able to provide an objective assessment of the manuscript. Please be aware of any conflicts of interest when recommending reviewers. Examples of conflicts of interest include (but are not limited to) the below:
The reviewer should have no prior knowledge of your submission,
The reviewer should not have recently collaborated with any of the authors,
Reviewer nominees from the same institution as any of the authors are not permitted.
Please note that the Editors are not obliged to invite/reject any recommended/opposed reviewers to assess your manuscript.
2.2 Authorship
Papers should only be submitted for consideration once consent is given by all contributing authors. Those submitting papers should carefully check that all those whose work contributed to the paper are acknowledged as contributing authors.
The list of authors should include all those who can legitimately claim authorship. This is all those who:
(i) Made a substantial contribution to the concept or design of the work; or acquisition, analysis or interpretation of data,
(ii) Drafted the article or revised it critically for important intellectual content,
(iii) Approved the version to be published,
(iv) Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.
Authors should meet the conditions of all of the points above. When a large, multicentre group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship.
Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship, although all contributors who do not meet the criteria for authorship should be listed in the Acknowledgments section. Please refer to the International Committee of Medical Journal Editors (ICMJE) authorship guidelines for more information on authorship.
2.3 Acknowledgements
All contributors who do not meet the criteria for authorship should be listed in an Acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, or a department chair who provided only general support.
2.3.1 Third party submissions
Where an individual who is not listed as an author submits a manuscript on behalf of the author(s), a statement must be included in the Acknowledgements section of the manuscript and in the accompanying cover letter. The statements must:
• Disclose this type of editorial assistance – including the individual’s name, company and level of input
• Identify any entities that paid for this assistance
• Confirm that the listed authors have authorized the submission of their manuscript via third party and approved any statements or declarations, e.g. conflicting interests, funding, etc.
Where appropriate, SAGE reserves the right to deny consideration to manuscripts submitted by a third party rather than by the authors themselves.
2.3.2 Writing assistance
Individuals who provided writing assistance, e.g. from a specialist communications company, do not qualify as authors and so should be included in the Acknowledgements section. Authors must disclose any writing assistance – including the individual’s name, company and level of input – and identify the entity that paid for this assistance.
It is not necessary to disclose use of language polishing services.
Any acknowledgements should appear first at the end of your article prior to your Declaration of Conflicting Interests (if applicable), any notes and your References.
2.4 Funding
Clinical Trials requires all authors to acknowledge their funding in a consistent fashion under a separate heading. Please visit the Funding Acknowledgements page on the SAGE Journal Author Gateway to confirm the format of the acknowledgment text in the event of funding, or state that: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
2.5 Declaration of conflicting interests
It is the policy of Clinical Trials to require a declaration of conflicting interests from all authors enabling a statement to be carried within the paginated pages of all published articles.
Please ensure that a ‘Declaration of Conflicting Interests’ statement is included at the end of your manuscript, after any acknowledgements and prior to the references. If no conflict exists, please state that ‘The Author(s) declare(s) that there is no conflict of interest’. For guidance on conflict of interest statements, please see the ICMJE recommendations here.
2.6 Research ethics and patient consent
Medical research involving human subjects must be conducted according to the World Medical Association Declaration of Helsinki
Submitted manuscripts should conform to the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, and all papers reporting animal and/or human studies must state in the methods section that the relevant Ethics Committee or Institutional Review Board provided (or waived) approval. Please ensure that you have provided the full name and institution of the review committee, in addition to the approval number.
For research articles, authors are also required to state in the methods section whether participants provided informed consent and whether the consent was written or verbal.
Information on informed consent to report individual cases or case series should be included in the manuscript text. A statement is required regarding whether written informed consent for patient information and images to be published was provided by the patient(s) or a legally authorized representative. Please do not submit the patient’s actual written informed consent with your article, as this in itself breaches the patient’s confidentiality. The Journal requests that you confirm to us, in writing, that you have obtained written informed consent but the written consent itself should be held by the authors/investigators themselves, for example in a patient’s hospital record. The confirmatory letter may be uploaded with your submission as a separate file.
Please also refer to the ICMJE Recommendations for the Protection of Research Participants.
All research involving animals submitted for publication must be approved by an ethics committee with oversight of the facility in which the studies were conducted. The journal has adopted the Consensus Author Guidelines on Animal Ethics and Welfare for Veterinary Journals published by the International Association of Veterinary Editors
2.7 Clinical trials
Clinical Trials conforms to the ICMJE requirement that clinical trials are registered in a WHO-approved public trials registry at or before the time of first patient enrolment as a condition of consideration for publication. The trial registry name and URL, and registration number must be included at the end of the abstract. Since Clinical Trials in general only considers for publication clinical trials that evaluate methodological innovations we expect these trials to be registered, even though the primary endpoint may or may not be a "health outcome".
2.8 Reporting guidelines
The relevant EQUATOR Network reporting guidelines should be followed depending on the type of study. For example, all randomized controlled trials submitted for publication should include a completed CONSORT flow chart as a cited figure and the completed CONSORT checklist should be uploaded with your submission as a supplementary file. Systematic reviews and meta-analyses should include the completed PRISMA flow chart as a cited figure and the completed PRISMA checklist should be uploaded with your submission as a supplementary file. The EQUATOR wizard can help you identify the appropriate guideline.
Other resources can be found at NLM’s Research Reporting Guidelines and Initiatives
Please be aware that the journal does not publish articles that essentially reproduce the protocol for an individual clinical trial and articles that simply report the results of a completed clinical trial are also not considered.
2.9 Research Data
The journal is committed to facilitating openness, transparency and reproducibility of research, and has the following research data sharing policy. For more information, including FAQs please visit the SAGE Research Data policy pages.
Subject to appropriate ethical and legal considerations, authors are encouraged to:
•share your research data in a relevant public data repository
•include a data availability statement linking to your data. If it is not possible to share your data, we encourage you to consider using the statement to explain why it cannot be shared.
•cite this data in your research
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更多详情：
https://journals.sagepub.com/author-instructions/CTJ
