Authors: Genpro Medical & Scientific Writing Team
Medical Writers often seek information on global best practices that will enhance scientific manuscript writing skills while adhering to industry standards. Here we provide contemporary guidelines that should be followed while publishing manuscripts in reputed journals especially while working on data reporting from clinical trials, systematic literature review and meta-analysis and other forms of peer reviewed publications.
Based on the type of study designs and manuscripts, there are different types of manuscript authoring guidelines such as CONsolidated Standards Of Reporting Trials (CONSORT) for randomized trials ; STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) for observational trials ; CAse REport guidelines (CARE) for case reports ; Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) for systematic reviews and meta-analyses ; and STAndards for Reporting of Diagnostic accuracy studies (STARD) for diagnostic accurateness . Journals encourage researchers to follow specific guidelines for writing manuscripts because it helps readers gain complete understanding of the study including its design, conduct, analysis, and interpretation and also assess the validity of published results.
There is a regulatory obligation for the manuscript of a study to be submitted to a regulatory authority. Manuscripts of licensed products must be submitted to the journal within 18 months after the last patient’s last visit. On the other hand, the manuscripts of investigational products must be submitted to the journal within 18 months after regulatory approval/product discontinuation . Presentation in congress and disclosure of partial clinical trial data is not considered prior to publication . In general, manuscripts reporting original research are divided into five sections, namely Introduction, Methods, Results, and Discussion (called “IMRAD” structure), which reflects the process of scientific findings. Other types of articles such as systematic reviews/meta-analyses may necessitate different presentations; case reports, narrative reviews, and letters to the editor may have less structured or unstructured presentations. The general necessities for reporting within sections of manuscript formats have been recommended by the International Committee of Medical Journal Editors (ICMJE) . For industry-sponsored research, it is advisable to follow Good Publication Practice guideline 3 (GPP3) . The Committee on Publication Ethics (COPE) guidelines should be followed for the ethical aspect of publication, especially to handle cases of research and publication misconduct that include, but are not limited to, data manipulation, duplicate publication, plagiarism, misuse of statistics, and false citations .
The ICMJE recommends that the manuscript’s title page should include the article title, author information with contact details of the corresponding author, disclaimers (if any), funding sources, conflict of interest/disclosure statement, authorship contribution, word count, number of tables/figures, and previous presentation, if any. Reporting guidelines recommend that information about study design is part of the title (particularly in case of randomized trials, systematic reviews, and meta-analyses). Some journals require a short title, typically not more than 40 characters (including letters and spaces) on the title page or as a distinct entry in an online submission system. Original research, systematic reviews, and meta-analyses require structured abstracts. The key contents of an abstract include background, aim/objective/purpose, methodology, results, and conclusion of the study. The methods section includes key eligibility criteria, setting, outcome measures, and assessment tools, including the key statistical method. The results section should include the effect size with p values and 95% CI range where available. The ICMJE recommends providing keywords of Medical Subject Headings and the clinical trial registration number at the end of the abstract. ICMJE provides a detailed recommendation of preparing the IMRAD sections and sub-sections. Also, ICMJE provides criteria for authorship, which all journals follow and it encourages researchers to submit the authorship contribution form at the time of manuscript submission. The GPP3 provides guidance on updated ICMJE 2013 authorship criteria and clarity on author payment and reimbursement including what constitutes ghost or guest authorship. Further, it provides guidance on appropriate data sharing. In addition, GPP3 sheds light on common issues regarding authorship.
Medical writers (MWs) usually do not qualify to be authors, except if they have made any substantial contribution, for example, to the narrative/systematic review/meta-analysis article. If MWs meet all the ICMJE or journal-specific authorship criteria, they will be treated as authors and their financial relationship with the sponsor must be disclosed appropriately in the disclosure section. As per GPP3 guidance, appropriately recognized professional MWs are not ghostwriters.
Moreover, publication guidelines encourage data sharing and disclosure of clinical study data, which increase transparency and faith in the publication process. However, publishing patient-level data causes breach of confidentiality. To avoid this issue, a few medical journals have necessitated making original data, including patient-level data and redacted protocols, accessible in repositories or on request [11, 12]. Some journals encourage including a data-sharing statement on the title page .
The ICMJE also recommends reporting guidelines for effective submission of manuscripts to journals. As a best practice for submitting articles to journals, authors often submit pre-submission enquiries to journals in order to understand the interest of the editor and avoid editorial rejection of the manuscript. Since manuscripts are submitted via online portals, journals encourage authors to read the author guidelines wherein complete guidance is provided to format articles as per the journal requirement. The most common files required by a journal are the title page, blinded manuscript, tables, and figures. Most journals have a restriction on the number of tables and figures and provide specific guidance on artwork. Authors must comply with the journal guidelines before submitting articles in their target journals. Most journals are of two types: open access and subscription-based. In case of open access journals, authors need to pay open access publication fees after acceptance of their article, and readers will have access to the full text article. In case of subscription-based journals, authors need not pay publication fees to the journal; however, readers need to pay subscription fees to the journal to get access to full text articles. Journals which offer the subscription-based option ask authors to sign a copyright transfer form after acceptance. After submission, the editorial team of the journal checks whether the author has submitted the article as per journal requirement. In case of any discrepancy, the editorial team flags it to the author who must rectify the issues and re-submit the article to the journal. Once the editorial team processes the article for the next step of editorial review, the editor assesses the article based on the novelty and scope of the journal. If the editor believes that the submitted article adds value to the scientific community, it is processed for the next step of peer review by sending a review invitation to at least four potential reviewers. Based on the review comments received from a minimum number of potential reviewers, the editor decides whether to reject the article, accept it as it is or accept it with minor or major changes and accordingly communicates the decision to the author.
- Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010;1(2):100-7.
- Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies. Int J Surg. 2014;12(12):1495-99.
- CARE guidelines. Available at: https://www.care-statement.org/.
- Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264-9.
- Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwiget LM, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. BMJ. 2003;326(7379):41-4.
- International Federation of Pharmaceutical Manufacturers & Associations; European Federation of Pharmaceutical Industries and Associations; Japan Pharmaceutical Manufacturers Association; Pharmaceutical Research and Manufacturers of America. Joint position on the publication of clinical trial results in the scientific literature. 10 June 2010..
- International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated December 2014. Accessed at icmje.org/recommendations on 12 January 2015.
- Preparing a Manuscript for Submission to a Medical Journal. Available at: http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html.
- Hesp BR, Arai K, Chu MY, Chuah S, Curameng JM, Kamat S, et al. A guide to applying the Good Publication Practice 3 guidelines in the Asia-Pacific region. Res Integr Peer Rev. 2019;4 Article 21.
- Publishing Ethics for Journals. A guide for Editors-in-Chief, Associate Editors, and Managing Editors: Available at: https://www.springer.com/gp/authors-editors/editors/publishing-ethics-for-journals/4176.
- Godlee F, Groves T. The new BMJ policy on sharing data from drug and device trials. [Editorial]. BMJ. 2012 Nov;345:e7888. doi:10.1136/bmj.e7888 PubMed PMID: 23169872.
- Public Library of Science Medicine. Data availability. Accessed at http://journals.plos.org/plosmedicine/s/data-availability on 8 May 2015.
- Annals of Internal Medicine. Information for authors: data sharing and reproducible research. Accessed at http://annals.org/public/authorsinfo.aspx#data-sharing-and-reproducible-research on 8 May 2015.