Rationale

• All clinical research should aim to answer important research questions and improve patient health
• The clinical or scientific rationale for some industry-sponsored studies is sometimes unclear to reviewers, editors, readers, and the public

Recommendations

• Sponsors should better explain how they decide which questions to address and the methodology to address them
• This additional context could be included in manuscripts, cover letters, and/or other formats/forums
• For example, sponsors could more transparently describe the nature of external advice (eg, advisory board members) obtained during study design and protocol development

References/Resources

Clark S, Horton R. Putting research into context — revisited. Lancet. 2010;376(9734):10-22.

Rationale

• All study outcomes should be made public in a timely fashion, irrespective of the nature of the results
• Results that are negative, confirmatory or inconclusive from well-designed studies can be challenging to publish in peer-reviewed journals, but are nonetheless important to disseminate to advance scientific understanding and prevent redundancy

Recommendations

• Sponsors and authors should seek to communicate results from “lower-impact” studies in appropriate venues with clear context and statement of limitations
• Editors and publishers should continue to explore ways they can support the dissemination of these results (eg, novel journals, article formats, and reviewing guidelines)
• In striving to avoid redundancy, all parties should collaborate to combat plagiarism

References/Resources

Clark J, Gonzalez J, Mansi B, et al. Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices initiative. Int J Clin Pract. 2010;64(8):1028-1033.

MPIP guide to journals accepting manuscripts of “specialized interest.”

Fighting plagiarism [editorial]. Lancet. 2008:371(9631):2146.

Rationale

• Conflict of interest (COI) reporting has improved thanks to efforts by various organizations, including ICMJE, and has contributed to enhanced credibility of publications from industry-sponsored studies
• However, there are persistent areas lacking consensus, including the reporting time frame and minimum reporting levels
• Furthermore, there is no current mechanism to validate authors’ COI reports

Recommendations

• All parties should support the use of ICMJE’s updated COI reporting form and actively participate in discussions regarding its improvement
• COI reporting standards should be applied uniformly to all authors, irrespective of their affiliation and the source of research funding
• All parties should explore the feasibility of creating a centralized COI database to promote transparency

References/Resources

ICMJE: Conflicts of Interest.

Lanier WL. Bidirectional conflicts of interest involving industry and medical journals: Who will champion integrity? Mayo Clinic Proc. 2009;84(9):771-775.

Steinbrook R. Online disclosure of physician-industry relationships. N Engl J Med. 2009;360(4):325-327.

Rationale

• Many authors have incomplete knowledge of how they can improve the credibility and quality of submitted manuscripts
• Particular gaps exist in formal writing education and knowledge of reporting guidelines such as the CONSORT requirements

Recommendations

• All parties should collaborate to educate authors in academia, industry, and other venues on publication development and should disseminate guides to best practices such as MPIP’s Authors’ Submission Toolkit and EQUATOR’s author resource library
• Editors and sponsors should also collaboratively explore areas of unmet need in author education that may warrant development of materials or educational programs
• Editors should participate in author education efforts in academia and spearhead efforts within and among journals to align policies and reviewer standards with best practices

References/Resources

Chipperfield L, Citrome L, Clark J, et al. Authors’ Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin. 2010;26(8):1967-1982.

EQUATOR resources for authors of research reports.

The CONSORT statement.

Rationale

• Many groups have developed definitions of authorship and contributorship, and these definitions have been incorporated into industry sponsors’ policies and standard practices
• These definitions explicitly renounce ghost writing (the exclusion of qualified individuals from inclusion as authors or contributors) and guest authorship (the inclusion as authors of individuals who do not qualify as such) and provide guidance for the appropriate role and recognition of professional writers
• Additional efforts are needed to completely eliminate ghost writing and guest authorship

Recommendations

• All parties should continue to work together to reinforce the fact that ghost writing and guest authorship are unacceptable practices
• Sponsors should use the same authorship and contributorship standards for employees and nonemployees, without applying quotas or prespecified ratios that would inappropriately exclude individuals who would otherwise qualify
• Journals should eliminate any biases against manuscripts with industry authors

References/Resources

ICMJE Recommendations: Defining the Role of Authors and Contributors:

AMWA Position Statement on the Contributions of Medical Writers to Scientific Publications.

Norris R, Bowman A, Fagan JM, et al. International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer. Curr Med Res Opin. 2007;23(8):1837-1840.

Rationale

• There is a continued need to ensure that adverse event claims made in publications are appropriately balanced and reflect the limitations of the trial design
• In addition, several common phrases used in reporting adverse events (eg, “no clinically significant adverse events,” “no unexpected adverse events”) provide insufficient detail, particularly for agents that may be used chronically in large patient populations

Recommendations

• All parties should continue to work toward developing and disseminating uniform adverse events reporting guidelines to provide better transparency in published manuscripts
• In this context, journals should consider whether they would prefer additional adverse event information to be present in the body of the paper and, if so, revise their manuscript length policies accordingly
• All parties should collaboratively educate authors on best practices in presenting adverse events in a fair, balanced, and clinically relevant manner

References/Resources

Ionnidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Int Med. 2004;141(10):781-788.

Rationale

• Some journals request study protocols during the review process to validate key manuscript components, screen for errors, and/or verify that protocol amendments did not affect the validity or integrity of the trial
• In addition, several journals post entire protocols or portions thereof on their websites to provide additional transparency and context to readers

Recommendations

• Journals should ensure their protocol submission and dissemination policies are clearly articulated in their “Instructions for Authors” and apply them to all manuscripts, irrespective of sponsorship
• All parties should discuss ways to surmount practical challenges of public protocol dissemination (eg, private or proprietary information, amendments), as well as the possible feasibility of a single public repository for study protocols

References/Resources

Chan AW. Bias, spin and misreporting: time for full access to trial protocols and results. PLoS Med. 2008;5(11):e230.

Rationale

• Journals require adequate clarity and quality of statistical reporting in order to assess the credibility of submitted manuscripts
• Existing guidelines have been incompletely instituted and enforced by authors, sponsors, and journals

Recommendations

• Sponsors and authors should ensure manuscripts adhere to best practices in reporting statistical methods
• Journals should ensure that reporting standards and other policies regarding statistical methods are universally applied to all manuscripts, irrespective of study sponsorship

References/Resources

The CONSORT statement.

Rationale

• To promote credibility, authors must be able to explain and defend key aspects of trial design and verify their ability to access the complete data set
• However, authors’ data access needs and feasibility may vary depending on the type of study (eg, a non-interventional trial versus a multicenter interventional trial)

Recommendations

• Sponsors should ensure their agreements with authors clearly delineate authors’ data access rights and responsibilities
• Journals should clearly state their policies on authors’ data access in their “Instructions for Authors”

References/Resources

Chipperfield L, Citrome L, Clark J, et al. Authors’ Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin. 2010;26(8):1967-1982.

Rationale

• When submitting a previously reviewed manuscript to a new journal, inclusion of prior reviews can help demonstrate that previous suggestions have been incorporated
• Many journals that accept prior reviews during the submission process believe this process increases manuscript quality and transparency

Recommendations

• Authors should consult specific journals’ “Instructions for Authors” or editors for guidance on whether prior reviews are accepted and, if so, share them as part of the new submission
• Journals should individually decide whether they wish to accept prior reviews and clearly articulate their policies in their “Instructions for Authors”
• Journals that decide to accept prior reviews should ensure reviewers are trained on how to use them and that authors are educated about their role in the review process

References/Resources

Chipperfield L, Citrome L, Clark J, et al. Authors’ Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin. 2010;26(8):1967-1982.