Authors' Submission Toolkit: A practical guide to getting your research published
August 2010, Vol. 26, No. 8 , Pages 1967-1982
(doi:10.1185/03007995.2010.499344)
Leighton Chipperfielda, Leslie Citromeb, Juli Clarkc, Frank S. Davidd, Robert Encke, Michelle Evangelistaf, John Gonzalezg, Trish Grovesh, Jay Magranni, Bernadette Mansij, Charles Millerj, LaVerne A. Mooneyk, Ann Murphyl, John Sheltonm, Philip D. Walsonn, Al Weigelo
aElsevier Health Sciences Global Medical Research, Oxford, UK
bInternational Journal of Clinical Practice; Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY, USA; New York University School of Medicine, New York, NY, USA
cAmgen, Thousand Oaks, CA, USA
dLeerink Swann, Boston, MA, USA
eAmerican Journal of Hospice and Palliative Medicine; East Tennessee State University College of Medicine, Johnson City, TN, USA
fLeerink Swann, Boston, MA, USA
gAstraZeneca, Cheshire, UK
hBMJ, London, UK
iCurrent Medical Research and Opinion (Informa), New York, NY, USA
jGlaxoSmithKline, King of Prussia, PA, USA
kPfizer Medical, New York, NY, USA
lThe Oncologist, Durham, NC, USA
mJournal of Clinical Psychiatry; Physicians Postgraduate Press, Inc., Memphis, TN, USA
nClinical Therapeutics, Hanover, Germany
oInternational Society for Medical Publication Professionals (ISMPP); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA
Address for correspondence:
Leighton Chipperfield, Elsevier Health Sciences,
The Boulevard, Langford Lane, Kidlington,
Oxford OX5 1GB, UK.
Tel: +44 1865 843 418; Fax: +44 1865 843 997;
Email: L.Chipperfield@elsevier.com
Preface
Dear Colleagues,
Biomedical journals have seen steady increases in submissions recently, partly owing to the introduction of legislation requiring clinical trial results reporting and to industry sponsors' policies that encourage publication of even early phase studies. Meanwhile, new journals continue to launch every week, providing an ever greater choice of places to publish research. Both factors present challenges when trying to find the right journal for an industry-sponsored study, particularly when authors and publication planners are reticent about communicating with journal editors and some editors may seem wary of direct approaches.
There is already plenty of guidance for authors on writing good manuscripts. In this article, we discuss the Authors' Submission Toolkit, a new resource for authors that tackles practical questions about manuscript preparation and the submission process that are incompletely addressed in existing guidance documents. The toolkit has been produced through the Medical Publishing Insights and Practices (MPIP) initiative, a project co-sponsored by members of the pharmaceutical industry and the International Society for Medical Publication Professionals (ISMPP) to enable open communication between authors and journal editors and to increase trust, transparency, and integrity in the process of peer reviewing and publishing industry-sponsored research.
We hope that the toolkit will provide useful and relevant information for authors, such as how to initiate appropriate collegial dialogue with journals and to help ensure that good research is being published in the right place. 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, much of which has traditionally been seen as mysterious to authors. We also hope that the toolkit will help to increase confidence in disclosing the role of professional medical writers as legitimate contributors to the process.
Finally, we hope that this initiative will help to increase trust between journal editors and the teams who produce industry-sponsored research: industry investigators, authors, publication planners, and medical writers.
Sincerely,
Trish Groves
Deputy Editor
British Medical Journal
Introduction
Purpose of the toolkit
Industry-sponsored clinical research has become more open and transparent in recent years due to changes in policy, regulation, and technology, as well as a general trend toward increased information access and sharing. The goals of greater transparency and expanded access to data are also driving a significant increase in the volume of manuscripts being developed and submitted to journals, which poses challenges to both the journals and the pharmaceutical industry. As a result, there is a need to improve efficiency in the submission process to accommodate this increased manuscript volume and mitigate resource demands on authors and editorial staff. These mutual goals can best be achieved through open dialogue and collaboration among key stakeholders.
The Authors' Submission Toolkit is a compilation of "best practices" in manuscript preparation and submission. It maintains a focus on research sponsored by the pharmaceutical industry, an area where medical publication practices and guidelines are continuing to undergo frequent refinement and evolution. It is intended to elevate transparency and integrity in medical publishing while improving efficiency. Specific objectives are as follows:
- Promote best practices and raise standards in manuscript preparation and submission
- Provide authors with resources to navigate the manuscript preparation and submission process
- Raise awareness of journal options for research data that is negative, confirmatory or of specialized interest
- Provide guidance to facilitate proper ethical collaborations between authors and industry
- Highlight practices that help increase the efficiency of submission and review for all stakeholders
- Increase awareness of guidelines regarding the role and proper acknowledgement of professional medical writers and third-party contributors
While the focus of the initial work is industry-sponsored clinical trials, many of the "best practices" captured may also be useful for authors of any study type. The authors recognize that many useful authors' resources are already available in the public domain and have referenced these sources in this document. The Resources section provided at the end of the article includes key documents and websites that address topics in the toolkit.
Organization
The toolkit, which walks authors through the key stages of the manuscript preparation and submission process, is divided into six sections. Each section is organized into several key sub-topics, and provides practical advice, identified through collaboration between journal editors, publishers, and pharmaceutical industry members.
MPIP & the development of the toolkit
The MPIP initiative was founded in 2008 by pharmaceutical industry members and the International Society for Medical Publication Professionals (ISMPP) to elevate trust, transparency, and integrity in publishing industry-sponsored studies. Current MPIP members include: AstraZeneca, Amgen, GlaxoSmithKline, Pfizer and ISMPP. MPIP's goals are to: (1) improve understanding of the issues and challenges faced by journals that publish industry-sponsored research; (2) identify potential solutions to increase transparency and trust; and (3) promote more effective partnership between sponsors and journals to raise standards in medical publishing and expand access to peer-reviewed data.
In September 2009, the MPIP convened a roundtable meeting to provide a forum for journal editors and publishers to identify and prioritize possible solutions to streamline the submission process, thus supporting prompt publication and dissemination of clinical trial results in the face of increasing manuscript volume. At the MPIP roundtable meeting, journal editors and publishers highlighted the need for an authors' guide to "best practices". A working group of editors and publishers from generalist and specialty journals and MPIP co-sponsor representatives was formed to create the Authors' Submission Toolkit. Members of the working group collaborated over a four-month period in early 2010 to clarify the aims, structure and content of the Toolkit and to draft, review and revise it.
