Manuscript Requirements
Journal Style
Clinical Therapeutics expects manuscripts to conform to the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” (the Vancouver style; N Engl J Med. 1997;336:309–315 or www.icmje.org). Reports of randomized controlled trials should conform to the CONSORT guidelines (www.consort-statement.org). A diagram illustrating the flow of participants through the trial is required. Tips for submission are available for download, see Author Resources on the right.
All manuscripts should be typed double-spaced, with the pages numbered. The title of the paper, followed by the full names of the authors; their highest academic degrees (eg, MD) and professional affiliation; and the complete contact information, including mailing address, phone, fax, and e-mail address of the corresponding author should appear on the title page only. If any material contained in the manuscript has been presented at a meeting, the full name, location, and inclusive dates of the meeting should appear on the title page; this information will be published if the article is accepted. A sponsored database would classify as a clinical trials registry, which would not be considered duplicate publication. Posting in this database does not exclude publication in the journal. We request, however, that mention be made to the posting in the manuscript and the registry number of the posting should be included after the abstract.
Language Services
Authors who require information about language editing and copyediting services prior to submission, please visit http://www.elsevier.com/locate/languagepolishing for more information. Please note, Elsevier neither endorses nor takes responsibility for any products, goods, or services offered by outside vendors through our services or in any advertising. For more information, please refer to our Terms & Conditions.
Authorship
As stated in the Uniform Requirements (see above), credit for authorship requires substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; drafting of the manuscript or critical revision for important intellectual content; and final approval of the version to be published. At time of submission, Clinical Therapeutics requires all authors to sign a statement that he or she accepts full responsibility for the conduct of the trial, had access to the data, and controlled the decision to publish. Each author of a review article must sign a statement that he or she approved the search terms, article selection, and manuscript outline, and accepts full responsibility for all conclusions drawn. Any change in authorship after submission must be approved in writing by all authors.
Financial Disclosure
All authors are required to disclose, in writing, any financial interests (eg, employment, consultancies, stock ownership or options other than mutual funds, honoraria, expert testimony) in the materials or subject matter dealt with in the manuscript. (Please consult the Uniform Requirements.) The information on this form, including financial material support of the research or project, will be published in an acknowledgement.
Cover Letter
Please include:
- Title, authors, number of pages, and numbers of tables and figures
- Indication that the paper has been read and approved by all authors
- Description of how each author contributed to the manuscript and others who may have assisted
- Name of the Special Section in which the paper is to be included, if applicable
- Information about any previous presentation of the data (eg, at a specific meeting)
- Information about the existence of any closely related manuscripts that have been submitted for simultaneous consideration to the same or another journal
- Notice of any interests that might be seen as influencing the research (eg, financial interest in a test or procedure, funding by pharmaceutical companies for drug research, etc)
- A copy of the permission granted to reproduce or adapt any copyrighted material from another source or a notice that permissions are pending
Manuscript Components
Papers
Original Research
Papers are to be organized as follows:
| (a) | Structured abstract (300 words or less), followed by 4 to 6 key words for indexing |
| (b) | Introduction |
| (c) | Patients and methods |
| (d) | Results |
| (e) | Discussion |
| (f) | Conclusions |
| (g) | Acknowledgments |
| (h) | References |
| (i) | Tables |
| (j) | Figures |
Please note that there are no text or graphic limits imposed on original research manuscripts.
Prospective, Observational, or Interventional Postmarketing Studies
Postmarketing studies must undergo review by an institutional review board (IRB) or ethics committee. Patients must give written informed consent unless a waiver of consent is allowed by the IRB. Patients must be informed of any real or potential conflicts of interest, including compensation of the investigator and potential costs to the patient that may result from their participation in the study. The amount of the remuneration of the investigators for their participation in postmarketing studies must be approved by the IRB/ethics committee. If the design of a prospective postmarketing study calls for a treatment intervention such as a switch or withdrawal, then criteria must be established a priori for patient selection, the implementation of the intervention, and assessment of success/failure of such intervention. Such criteria must be scientifically justified, documented, uniformly applied and enforced, and clearly reported in the study report. Additionally, the patient or his/her insurance provider will not be required to pay for costs related to prospective interventions, such as those that may result from a drug switch or withdrawal.
These criteria do not apply to retrospective observational studies, such as chart reviews, postmarketing safety surveillance studies, or government-mandated Phase IV trials.
Review Articles
Comprehensive evidence-based reviews and meta-analyses of the literature are welcomed. For the Pharmaceutical Economics & Health Policy section, only systematic reviews and meta-analyses will be considered. Authors should contact one of the editors to discuss the topic area to avoid duplication with previously submitted or accepted manuscripts. For more information about what constitutes a good review, see CP Mulrow (The medical review article: State of the science. Ann Intern Med 1987;106:485–488) and AD Oxman et al. (User’s guide to the medical literature. VI. How to use an overview. Evidence-based medicine working group. JAMA 1994;272:1367–1371).
The review should include an accurate, succinct title; a structured abstract; an introduction that specifies the purpose of the review; methods section that identifies the databases that were searched, search terms used, and inclusion/exclusion criteria for identified articles; an assessment of the validity of reviewed studies; and a summary that includes future directions for studies in this area. Each study mentioned in the review should include the study design, a description of the study population (age range, disease/severity), the dose and duration of each treatment administered, and the data and P values to support any mentions of significant findings.
Abstract: 300 words
Text: 5500–6000 words
References: 95
Graphics: 4–8
Consensus Statements
These papers are guidelines developed by an independent panel of experts within the stated specialty and are based on the current state of knowledge in that area. The submission should include an unstructured abstract; an introduction clearly describing the objective, member selection, and development of the panel; details of how opinions were formalized (including how disagreements were addressed); a fully-referenced description of each recommendation; a comprehensive conclusion; acknowledgment of financial and editorial support including detailed conflict of interest statements from all parties involved in the panel and manuscript creation; and references.
Abstract: 300 words
Text: 5000 words
References: 80
Graphics: 6
Pharmacokinetic, Bioavailability, or Bioequivalence Studies
See Specialty Section for more information. Download Tips for Submitting Bioequivalence Studies for manuscript preparation instructions.
Contemporary Issues
These papers are topical issues of general interest with bearing on scientific or clinical research. The submission should include all standard sections required in an original research report.
Abstract: 300 words
Text: 5000 words
References: 80
Graphics: 6
Commentaries
These papers address an important issue in clinical medicine, health policy, or medical research in a thorough, well-referenced, systematic, or evidence-based manner. The submission should include a structured abstract, an introduction, pertinent information detailing the position of the paper, a discussion, a conclusion, and references.
Abstract: 300 words
Text: 3000–3500 words
References: 60
Graphics: 5
Perspectives
The Perspective category is designed for brief communications that advance an opinion or provide a perspective on timely or high-priority topics (rather than a systematic or evidence-based treatment of an issue), and stimulate useful exchanges among scholars, practitioners, government agencies, provider organizations, and pharmaceutical companies.
Abstract: 250 words
Text: 2500 words
References: 15
Graphics: 2
Brief Reports
These papers are reports of preliminary clinical investigations that are narrowly focused or provide limited findings. The submission should include an accurate and succinct title, a structured abstract, an introduction that specifies the importance of the study, a methods section, results, a discussion, a conclusion, and references.
Abstract: 250 words
References: 30
Text: 2000–3000 words
Graphics: 3
Case Reports
New or unusual events in 1 or more patients that provide important information about adverse drug reactions, drug–drug interactions, or drug–disease interactions should be submitted as Letters to the Editor. The types of case reports generally include unique cases, unexpected associations, or unexpected events. Suspected adverse drug events must be reported to the corresponding regulatory agency or the manufacturer prior to submission for publication. Reports of suspected adverse drug reactions should provide a description of the event, details regarding the implicated medication (purpose, when initiated), previous adverse drug reactions with similar drugs, effects of dechallenge or rechallenge, and treatment for the reaction. Please do not submit cases purporting to establish drug efficacy. The report should be factual, concise, logically organized, and clearly presented. In the case of adverse drug events, please use the Naranjo Adverse Drug Reaction probability scale to determine the likelihood that the events were drug-related (Naranjo CA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–245).
The report should include a succinct title, introduction/objective, case description, discussion, conclusion, and references. A table or figure may be included. The introduction should briefly announce the subject and purpose of the report, including why the case is important and how the literature search was performed. The case description should include a narrative account of the case with brief, pertinent clinical, laboratory, and medication information. The discussion should comment on evidence that the case is new or unusual and consider possible alternative explanations for case features. The conclusion should provide a summary of the adverse drug reaction–medication relationship, how to treat it, and how to avoid it.
For more information about what constitutes a good case report, see Vandenbroucke JP. In defense of case reports and case series. Ann Intern Med. 2001;134:330–334 and DeBakey L, DeBakey S. The case report. I. Guidelines for preparation. Int J Cardiol. 1983;4:357–364.
References: 5
Text: 600 words
Graphics: 1
Research Letters
These are planned or follow-up subgroup analyses of previously published randomized trials. Alternatively, research letters can present novel research that may stimulate further investigation or alert readers to clinically relevant but preliminary findings. The submission should include an accurate and succinct title; an unstructured abstract; an introduction that specifies the rationale for the study, beginning with a statement similar to “This communication provides…”; the body of the letter, describing the methods, results, and conclusion; and references.
Abstract: 100 words
References: 15
Text: 1000–1500 words
Graphics: 2
Letters to the Editor
These are objective, constructive, or educational critiques of papers published in Clinical Therapeutics. Accepted letters will be sent to the author of the original paper for a response. Each letter and response is published together. Alternatively, letters may focus on reports of adverse events or topical issues that are of interest to readers of Clinical Therapeutics.
Text: 600 words
References: 5
Graphics: 1
Drugs should be referred to by their universally accepted generic names, not by company trademarks. US adopted names (USANs) are acceptable. Footnotes and uncommon abbreviations should be avoided whenever possible. When abbreviations or symbols are used, they should be defined in the text the first time they appear as well as in the tables and figures. Any material that has been published elsewhere must be accompanied by written consent from the original author and publisher for print and electronic reproduction.
Manuscript Preparation
Acknowledgments
Financial Disclosure Policy
All authors are required to disclose, in writing, any financial interests (eg, employment, consultancies, stock ownership or options other than mutual funds, honoraria, expert testimony) in the materials or subject matter dealt with in the manuscript. (Please consult the Uniform Requirements.) The information on this form, including financial material support of the research or project, will be published in an acknowledgement.
Role of the Funding Source
All sources of funding must be declared in the Acknowledgments section of the manuscript. The role of study sponsors in the study design; in data collection, analysis, and interpretation; in the writing of the manuscript; and in submission for publication must be declared. If the study sponsors were not involved, this must be stated as well.
Manuscript Preparation
All contributors who do not meet the criteria for authorship should be listed in the Acknowledgments section of the manuscript. Contributors include those individuals who provide technical or writing assistance or general support. Any paid assistance, as well as the funding source for such assistance, must be identified.
Registration Policy
Clinical Therapeutics strongly recommends that all clinical trials (Phase I to Phase IV) are registered with any of the WHO Primary Registries or an ICMJE approved registry before initiation of the study or even after starting the study. Failure to register a clinical trial may result in rejection of the manuscript at the Editor-in-Chief’s discretion or may require a published acknowledgment indicating the reasons for noncompliance.
References
The accuracy of all references cited is the responsibility of the author. References should be numbered in the order in which they appear in the text and the full references listed in the corresponding order at the end of the text. Data on file and material that has been “submitted for publication” should not be included in the references.
Journal Articles
References to journal articles should include the last names and initials of the authors; full title of the article; full title of the journal, italicized; year of publication; volume number; and inclusive pages of the article. For example:
Smith HL, Wright JK, Cherry JD. Influenza virus infections in infants. Lancet. 2002;23:230–239.
Books
References to books should include the last names and initials of the authors and/or editors; chapter title; book title, italicized; edition number; place of publication; publisher; year of publication; and inclusive pages. For example:
Nicholson KG. Human influenza. In: Nicholson KG, Hay AG, Webster RG, eds. Textbook of Influenza. Boston, Mass.: Blackwell Science; 2002:219–264.
Web Sites
References to Web sites should include its name, article title, web address, and date the Web site was accessed. For example:
Health Care Financing Administration. 1996 Statistics at a glance. http://www.hcfa.gov/stats/stathili.htm. Accessed December 2, 1996.
Tables
Each table should be prepared in Microsoft Word and inserted after the references. Each table should:
- be referred to in the text;
- be numbered in the order of appearance;
- include a short, descriptive title;
- be on a separate page.
Figures
Figures should be created in Adobe Illustrator and submitted electronically (.pdf or .eps format); photographs and photocopies are not usable. Figures submitted in any other format may be redrawn, and authors will be responsible for the accuracy of the new illustrations.
Each figure should be:
- referred to in the text;
- numbered in the order of appearance;
- on a separate page.
A numbered list of short, descriptive figure legends should be included at the end of the paper. The author is responsible for any additional fees for color illustrations.
File Formats
Electronic submissions should adhere to the following file formats:
Microsoft Word [PC/Mac] (.doc)
- Cover letter
- Contact information for all authors/coauthors
- List of submission contents
- Manuscript (Microsoft Word document, double-spaced, 12-point Arial font, with page numbers)
- Tables (Microsoft Word only)
Adobe PDF (.pdf) or Adobe Illustrator EPS (.eps)
- Figures
