Clinical Therapeutics

Introduction

Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug therapy and pharmaceutical economics, as well as in-depth supplements on specific drug therapies or disease states. The journal serves an international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings by quickly disseminating research findings. In addition, the articles are indexed by all major biomedical abstracting databases.

Published articles range from studies exploring new drugs and new indications for existing drugs to large, multicenter Phase III and IV trials. In addition to publishing the results of a broad range of multispecialty clinical studies, the journal features 3 specialty sections: Pediatric, Adolescent, & Maternal Therapeutics, which addresses matters regarding safe and effective drug therapy in neonates, infants, children, adolescents, and pregnant or lactating women; Pharmaceutical Economics & Health Policy, which addresses pharmacoeconomic, health outcomes, and contemporary issues related to drug therapy; and Pharmacokinetics, Bioavailability, & Bioequivalence, which features pharmacokinetic studies conducted to assess the bioequivalence of generic and branded pharmaceuticals and/or alternative formulations. The journal also encourages submission of brief reports and commentaries on topics that are timely or provocative.

All manuscripts are peer reviewed by at least 2 independent researchers for clinical relevance, technical accuracy, methodologic rigor, clarity, and objectivity using a double-blind review process.

Before you begin

Pre-submission enquiries
Clinical Therapeutics is delighted to respond to pre-submission inquiries. Please send a letter of inquiry together with your proposed manuscript title and abstract for consideration to the editorial office at clinther@elsevier.com; all queries will be dealt with promptly.

Online Submission of Manuscripts
http://ees.elsevier.com/clinther
Submission and peer review of all papers is now conducted entirely online, increasing efficiency for editors, authors, and reviewers, and enhancing publication speed. Authors are guided stepwise through the entire process, and are kept abreast of the progress of their paper at each stage. All correspondence, including the Editor's decision and request for revisions, is conducted via e-mail.

Express Track peer review service
For time-sensitive manuscripts, Clinical Therapeutics offers this optional service for a fee of USD750/EUR530/JPY60,600 per submitted manuscript for Original Research; Pharmacokinetics, Bioavailability, & Bioequivalence; and Research Letters. This fee is nonrefundable and noncancellable. High-quality peer review is completed within 5-10 business days. Reject or revise decision is provided to the author within 3 business days of receipt of reviewers' comments by the editorial office. Upon receipt, we provide a final decision on revised manuscripts within 15 business days (excluding requests for subsequent revisions). Accepted manuscripts are published online in advance of print, and are scheduled for publication in the next available issue (subject to publisher approval). If you would like to use Express Track peer review service, please request this in your cover letter.

Page charges: Standard Manuscripts
A fee of $500 per printed journal page is charged for accepted papers to defray distribution costs, thereby allowing papers to be published online as Articles in Press within 20 business days of acceptance (subject to prompt turnaround of proof by author). The ability to pay the fee does not influence decisions regarding the acceptance of a paper, which is solely dependent on the peer-review process.

Waiver Policy
If you have no funding for page charges, please state the reason at the time of submission and provide documentation which supports your request, or clearly indicates that your research/study/grant does not support funds for publication. Page charges for exceptional papers that are not sponsored or otherwise supported by industry, a university grant, or alternative forms of support may be reduced or waived at the publisher's discretion. Please complete the Waive Fee Request form and upload it with your manuscript and documentation at the time of submission. Note that Express Track manuscripts are not eligible for a reduced or waived fee. No fee waiver will be granted after a manuscript is submitted.

Page charges: Express Track Manuscripts
A fee of $750 per printed journal page is charged for accepted Express Track papers, thereby allowing papers to be reviewed within 5-10 business days and published online as Articles in Press within 20 business days of acceptance, and in print in the next available issue.

Payment of author fees
Express Track fees: Authors requesting the Express Track peer review service will receive payment instructions once their paper has been received by the Editorial Office.
Page fees for accepted papers: Authors of accepted papers will receive payment instructions once their article is in its final form for publication. Contact the Journal Editorial Office (clinther@elsevier.com) for all queries.

Online Publication
Fully typeset, copyedited and citable versions of all articles are typically published online 20 business days after acceptance (subject to prompt turnaround of proof by author), in advance of publication in a printed issue.

General resources
For information on Ethics in Publishing and Ethical guidelines for journal publication see http://www.elsevier.com/publishingethics and http://www.elsevier.com/ethicalguidelines. Prospective authors are encouraged to read the Authors' Submission Toolkit: A practical guide to getting your research published (available at http://www.cmrojournal.com/ipi/ih/MPIP-author-toolkit.jsp). The toolkit summarizes tips and "best practices" to increase awareness of editorial requirements, journal selection, submission processes, publication ethics, peer review, and effective communication with editors.

Policy and ethics
The work described in your article must have been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans http://www.wma.net/en/30publications/10policies/b3/index.html; EC Directive 86/609/EEC for animal experiments
http://ec.europa.eu/environment/chemicals/lab_animals/legislation_en.htm; Uniform Requirements for manuscripts submitted to Biomedical journals http://www.icmje.org. This must be stated at an appropriate point in the article.

Submission declaration
Submission of an article implies that the work described has not been published previously (except in the form of an abstract or as part of a published lecture or academic thesis), that it is not under consideration for publication elsewhere, that its publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out, and that, if accepted, it will not be published elsewhere including electronically in the same form, in English or in any other language, without the written consent of the copyright-holder.

Authorship
All authors should have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, (3) final approval of the version to be submitted.

Changes to authorship
This policy concerns the addition, deletion, or rearrangement of author names in the authorship of accepted manuscripts: Before the accepted manuscript is published in an online issue: Requests to add or remove an author, or to rearrange the author names, must be sent to the editorial office from the corresponding author of the accepted manuscript and must include: (a) the reason the name should be added or removed, or the author names rearranged and (b) written confirmation (e-mail, fax, letter) from all authors that they agree with the addition, removal or rearrangement. In the case of addition or removal of authors, this includes confirmation from the author being added or removed. Note that publication of the accepted manuscript in an online issue is suspended until authorship has been agreed.

After the accepted manuscript is published in an online issue: Any requests to add, delete, or rearrange author names in an article published in an online issue will follow the same policies as noted above and result in an erratum.

Reporting clinical trials
All randomized controlled trials submitted for publication should include a completed Consolidated Standards of Reporting Trials (CONSORT) flow chart. Please refer to the CONSORT statement website at http://www.consort-statement.org for more information. This journal has adopted the proposal from the International Committee of Medical Journal Editors (ICMJE) which require, as a condition of consideration for publication of clinical trials, registration in a public trials registry. Trials must register at or before the onset of patient enrollment. The clinical trial registration number should be included at the end of the abstract of the article. For this purpose, a clinical trial is defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example drugs, surgical procedures, devices, behavioral treatments, dietary interventions including vitamin or herbal supplements, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. Further information can be found at http://www.icmje.org.

Studies that were initiated without registration can be registered retrospectively and will be considered for publication on a subjective basis.

Prospective, Observational, or Interventional Pre- and Post -marketing Studies
Pre- or post-marketing 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 pre- or post-marketing studies must be approved by the IRB/ethics committee. If the design of a prospective pre- or post- marketing 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.

All other studies that involve identifiable human subjects, including retrospective studies, chart reviews, post-marketing surveillance studies, or government mandated phase IV trials require IRB or ethics committee approval or waiver.

In each case, detailed IRB or ethics committee information should be clearly stated in the Methods section.

Studies that only utilize pre-existing, de-identified (according to HIPAA standards) patient data are not required to seek IRB approval.

Retained author rights
As an author you (or your employer or institution) retain certain rights; for details you are referred to: http://www.elsevier.com/authorsrights. Funding body agreements and policies
Elsevier has established agreements and developed policies to allow authors whose articles appear in journals published by Elsevier, to comply with potential manuscript archiving requirements as specified as conditions of their grant awards. To learn more about existing agreements and policies please visit: http://www.elsevier.com/fundingbodies.

Language and language services
Please write your text in standard, grammatically correct English. Authors who require information about language editing and copyediting services pre- and post-submission please visit http://webshop.elsevier.com/languageediting or our customer support site at http://support.elsevier.com for more information.

Additional information
Drugs should be referred to by their universally accepted generic names, not by company trademarks. US adopted names (USANs) are acceptable. If unnamed compounds are referred to, as much information as possible (e.g., class of compound) should be included and published references to the compound should be provided. If this is not possible because of intellectual property reasons then this should be stated.

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.

TYPES OF SUBMISSIONS

Original Research

Review Articles and Meta-analyses

Consensus Statements

Pharmacokinetic, Bioavailability, or Bioequivalence Studies

Contemporary Issues

Commentaries

Perspectives

Brief Reports

Research Letters

Letters to the Editor

Electronic artwork
General points
• Make sure you use uniform lettering and sizing of your original artwork.
• Save text in illustrations as "graphics" or enclose the font.
• Only use the following fonts in your illustrations: Arial, Courier, Times, Symbol.
• Number the illustrations according to their sequence in the text.
• Use a logical naming convention for your artwork files.
• Provide legends to illustrations separately.
• Produce images near to the desired size of the printed version.
• Submit each figure as a separate file.

A detailed guide on electronic artwork is available on our website: http://www.elsevier.com/artworkinstructions You are urged to visit this site; some excerpts from the detailed information are given here.

Formats
Regardless of the application used, when your electronic artwork is finalized, please "save as" or convert the images to one of the following formats (note the resolution requirements for line drawings, halftones, and line/halftone combinations given below):

TIFF: color or grayscale photographs (halftones): always use a minimum of 300 dpi.
TIFF: Bitmapped line drawings: use a minimum of 1000 dpi.
TIFF: Combinations bitmapped line/half-tone (color or grayscale): a minimum of 500 dpi is required.
If your electronic artwork is created in a Microsoft Office application (Word, PowerPoint, Excel) then please supply "as is".
Please do not:
• Supply files that are optimized for screen use (like GIF, BMP, PICT, WPG); the resolution is too low;
• Supply files that are too low in resolution;
• Submit graphics that are disproportionately large for the content.

Color artwork
Please make sure that artwork files are in an acceptable format (TIFF or jpg) and with the correct resolution. If, together with your accepted article, you submit usable color figures then Elsevier will ensure, at no additional charge, that these figures will appear in color on the Web (e.g., ScienceDirect and other sites) regardless of whether or not these illustrations are reproduced in color in the printed version. For color reproduction in print, you will receive information regarding the costs from Elsevier after receipt of your accepted article. Please indicate your preference for color in print or on the Web only. For further information on the preparation of electronic artwork, please see http://www.elsevier.com/artworkinstructions. Please note: Because of technical complications which can arise by converting color figures to "gray scale" (for the printed version should you not opt for color in print) please submit in addition usable black and white versions of all the color illustrations.

Figure legends
Ensure that each illustration has a legend. Supply legends in a separate section following the bibliography, not attached to the figure. A legend should comprise a brief title (not on the figure itself) and a description of the illustration. Keep text in the illustrations themselves to a minimum but explain all symbols and abbreviations used.

Tables
Number tables consecutively in accordance with their appearance in the text. Place footnotes to tables below the table body and indicate them with superscript lowercase letters. Avoid vertical rules. Be sparing in the use of tables and ensure that the data presented in tables do not duplicate results described elsewhere in the article.

References
Citation in text
Please ensure that every reference cited in the text is also present in the reference list (and vice versa). Any references cited in the abstract must be given in full. Personal communications should not be included in the reference list, but in the text immediately following the referenced material. Citation of a reference as "in press" implies that the item has been accepted for publication.

Unless there are compelling reasons to do so, which should be clearly communicated to the editor, "data on file," "internal reports," material that has been "submitted for publication," and related non-peer-review sources are prohibited. Likewise, meeting abstract data, even if published, should be avoided.

Package inserts are not valid data sources unless in reference to prescribing information such as dosing. All other drug information should be derived from the primary literature and cited accordingly.

Reference style
Text: Indicate references by superscript number(s) in line with the text. The actual authors can be referred to, but the reference number(s) must always be given.
Example: "..... as demonstrated.^3,6 Barnaby and Jones⁸ obtained a different result ...." List: Number the references in the list in the order in which they appear in the text. The reference format in the bibliography should follow the style described in the American Medical Association Style Guide, 10th Edition (AMA 10).


Sample references:

Book: Charmaz K. Constructing Grounded Theory. Thousand Oaks, Calif: Sage Publications; 2006.
Book, new edition: Stewart AJ, Malley JE, LaVaque-Manty D, eds. Transforming Science and Engineering: Advancing Academic Women. 4th ed. Ann Arbor, Mich: University of Michigan Press; 2007.Chapter in a book: Frankel LR. The report of the CASRO task force on response rates. In: Weisman F, ed. Improving Data Quality in Sample Survey. Cambridge, Mass: Marketing Science Institute; 1983:1-11.Edited book: Rodrigues A, Levine RV, eds. Reflections on 100 Years of Experimental Social Psychology. Boulder, Colo: Westview Press, 1999.
Journal article: Dempsey F, Cowan AE, Broder KR, et al. Adolescent Tdap vaccine use among primary care physicians. J Adolesc Health. 2009;44:387-393.
Journal article in a foreign language: Leentjens AF, Kragten JA. Complete atrioventricular block during galantamine therapy [in Dutch]. Ned Tijdschr Geneeskd. 2006;150:563-566.
Journal article (suppl): Smith PJ, Battaglia MP, Huggins VJ, et al. Overview of the sampling design and statistical methods used in the National Immunization Survey. Am J Prev Med. 2001;20(Suppl 4):S17-S24.
Journal article with correction: Centers for Disease Control and Prevention (CDC). National vaccination coverage among adolescents aged 13-17 years-United States, 2007 [published correction appears in MMWR Morb Mortal Wkly Rep. 2009;58:10]. MMWR Morb Mortal Wkly Rep. 2008;57:1100-1103.
Journal article with study group(s) as author: Szilagyi PC, Rand CM, McLaurin AJ, et al, for the Working Group on Adolescent Vaccination in the Medical Home. Delivering adolescent vaccinations in the medical home: a new era? Pediatrics. 2008;121(Suppl 1):S15-S24. Package insert: Cialis [package insert]. Indianapolis, Ind: Eli Lilly & Co; 2003. Januvia [prescribing information]. Whitehouse Station, NJ: Merck & Co, Inc; 2009.
Paper/abstract presented at a conference: Khare M, Singleton J, Wouhib A, Jain N. Assessment of potential bias in the National Immunization Survey (NIS) from the increasing noncoverage of non-landline telephone households. Abstract presented at: 42nd National Immunization Conference; March 17-20, 2008; Atlanta, Ga.
Theses and dissertations: Fenster SD. Cloning and Characterization of Piccolo,a Novel Component of the Presynaptic Cytoskeletal Matrix [dissertation]. Birmingham, Ala: University of Alabama; 2000.
Web site: Association of American Medical Colleges (AAMC). 2007 AAMC data book: medical schools and teaching hospitals by the numbers. http://www.aamc.org/data/databook/start.htm. Accessed June 17, 2010.

Personal communication: In text following referenced material: (Name of practitioner, Occupation, Personal communication, Date when the information was provided).

Journal abbreviations source
Journal names should be abbreviated according to Index Medicus journal abbreviations: http://www.nlm.nih.gov/tsd/serials/lji.html.

List of title word abbreviations: http://www.issn.org/2-22661-LTWA-online.php.

CAS (Chemical Abstracts Service): http://www.cas.org/sent.html.

Supplementary data
Elsevier accepts electronic supplementary material to support and enhance your scientific research. Supplementary files offer the author additional possibilities to publish supporting applications, high-resolution images, background datasets, sound clips and more. Supplementary files supplied will be published online alongside the electronic version of your article in Elsevier Web products, including ScienceDirect: http://www.sciencedirect.com. In order to ensure that your submitted material is directly usable, please provide the data in one of our recommended file formats. Authors should submit the material in electronic format together with the article and supply a concise and descriptive caption for each file. For more detailed instructions please visit our artwork instruction pages at http://www.elsevier.com/artworkinstructions.

Submission checklist
The following list will be useful during the final checking of an article prior to sending it to the journal for review. Please consult this Guide for Authors for further details of any item.

Ensure that the following items are present:
Cover letter:
• 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

Title page
• Full title; running title of 120 characters or less
• All authors listed with academic degrees and affiliations
• One author designated as corresponding Author
• E-mail address
• Full postal address
• Telephone and fax numbers
• Keywords
• Manuscript with text pages numbered
• All figure legends (if applicable)
• All figures (if applicable) uploaded individually
• All tables (including title, description, footnotes) uploaded individually

Further considerations:
• Manuscript has been spell-checked and grammar-checked
• References are in the correct format for this journal (AMA 10)
• All references mentioned in the Reference list are cited in the text, and vice versa
• Permission has been obtained for use of copyrighted material from other sources (including the Web)
• Color figures are clearly marked as being intended for color reproduction on the Web (free of charge) and in print or to be reproduced in color on the Web (free of charge) and in black-and-white in print
• If only color on the Web is required, black and white versions of the figures are also supplied for printing purposes

For any further information please visit our customer support site at http://support.elsevier.com.

Failure to comply with any or all of these guidelines could result in rejection of an otherwise acceptable paper.

Upon Revision - Promotion of Your Article

At the time you submit the revised version of your article, please compose a question for which your paper's subject, topic or title is an answer. We will take your question, attach your paper's web address, and use it for social media promotion on Twitter. See example, below:

Author composed question:

How common are adverse events after corticosteroid treatment?

The answer is the author's paper, "Incidence and US Costs of Corticosteroid-Associated Adverse Events: A Systematic Literature Review," which the Clinical Therapeutics editorial office will translate to a bit.ly URL, http://bit.ly/sFmbgF (a shortened web address) and attach it to the question:

The final product, the question and the shortened web address, is the message we will promote on Twitter, to boost awareness and drive traffic to the published content.

How common are adverse events after corticosteroid treatment?

http://bit.ly/sFmbgF

After Acceptance

Use of the Digital Object Identifier
The Digital Object Identifier (DOI) may be used to cite and link to electronic documents. The DOI consists of a unique alpha-numeric character string which is assigned to a document by the publisher upon the initial electronic publication. The assigned DOI never changes. Therefore, it is an ideal medium for citing a document, particularly 'Articles in press' because they have not yet received their full bibliographic information. The correct format for citing a DOI is shown as follows (example taken from a document in the journal Physics Letters B): doi:10.1016/j.physletb.2010.09.059 When you use the DOI to create URL hyperlinks to documents on the web, they are guaranteed never to change.

Proofs
One set of page proofs (as PDF files) will be sent by e-mail to the corresponding author or a link will be provided in the e-mail so that authors can download the files themselves. Elsevier now provides authors with PDF proofs which can be annotated; for this you will need to download Adobe Reader version 7 (or higher) available free from http://get.adobe.com/reader. Instructions on how to annotate PDF files will accompany the proofs (also given online). The exact system requirements are given at the Adobe site: http://www.adobe.com/products/reader/systemreqs. If you do not wish to use the PDF annotations function, you may list the corrections (including replies to the Query Form) and return them to Elsevier in an e-mail. Please list your corrections quoting line number. If, for any reason, this is not possible, then mark the corrections and any other comments (including replies to the Query Form) on a printout of your proof and return by fax, or scan the pages and e-mail. Please use this proof only for checking the typesetting, editing, completeness and correctness of the text, tables and figures. Significant changes to the article as accepted for publication will only be considered at this stage with permission from the Editor. We will do everything possible to get your article published quickly and accurately - please let us have all your corrections within 48 hours. It is important to ensure that all corrections are sent back to us in one communication: please check carefully before replying, as inclusion of any subsequent corrections cannot be guaranteed. Proofreading is solely your responsibility. Note that Elsevier may proceed with the publication of your article if no response is received.

Offprints
The corresponding author, at no cost, will be provided with a PDF file of the article via e-mail. For an extra charge, paper offprints can be ordered via the offprint order form which is sent once the article is accepted for publication. The PDF file is a watermarked version of the published article and includes a cover sheet with the journal cover image and a disclaimer outlining the terms and conditions of use.

Author Inquiries

Contact details for questions arising after acceptance of an article, especially those relating to proofs, will be provided by the publisher. You can track accepted articles at http://www.elsevier.com/trackarticle. You can also check our Author FAQs (http://www.elsevier.com/authorFAQ) and/or contact Customer Support via http://support.elsevier.com.



Updated April 2012