John P. Gonzalez, PhD, ISMPP CMPPTM, Solanum Medical Communications, The BioHub, Alderley Park, Macclesfield, UK
Rigorous journal peer review ensures the quality of manuscripts and, ultimately, the credibility of the published literature. Peer reviewers should have access to documentation relating to the research they are reviewing. In an era of so-called fake news, predatory publishing, and scrutiny of industry activities, quality publications are even more important in helping to improve confidence and trust in industry research and the medicines delivered to patients.
Supporting documentation, such as protocols, statistical analyses plans (SAP), and completed CONSORT Statement checklists, are now routinely required by many journals to accompany manuscript submissions of original clinical research to assist peer reviewers. This has become the norm. Likewise, on manuscript acceptance, there is often the requirement that these documents will be made publicly accessible as a condition of publication. Whereas some sponsors may have concerns regarding release of additional information of a confidential or proprietary nature during the manuscript publishing process, there are ways to mitigate this risk by redacting any sensitive information in the documents prior to their release.
ICMJE Recommendations for Supporting Documentation
The International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals state that editors are encouraged to review research protocols and, if separate from the protocol, the SAPs, as part of the manuscript peer review process.1 Furthermore, ICMJE wants journal editors to encourage authors to make such documents publicly available at the time of or after publication, before accepting studies for publication. These recommendations are not mandatory, but, when journals request ICMJE listing, it is assumed that they will follow these recommendations.
More recently, ICMJE has extended data sharing requirements for its member journals to include data sharing statements in clinical trial manuscripts and data sharing plans in trial registrations.2 Some journals, such as the British Medical Journal and Annals of Internal Medicine, had already included a data sharing requirement as a condition of manuscript acceptance. This additional transparency is welcomed and can only be good for the patient.
In practice, journals vary in the way they apply the recommendations on supplementary information, so it is always best to refer to the journal’s instructions to authors.
Varying Journal Instructions to Authors
Annals of Internal Medicine, an ICMJE member journal, requires authors that submit manuscripts reporting the results of a clinical trial to submit a copy of the study protocol with all dated amendments. If the manuscript is accepted for publication, the protocol will be published as a supplement to the article on the journal’s website. If necessary, Annals will consider publication of protocols with redacted proprietary information from introduction and background sections.
Similarly, the Journal of Clinical Oncology (JCO) wants editors, reviewers, and readers to have access to the protocol for randomized phase 2 and 3 studies. The protocol can be provided in a redacted form (required sections are specified in the instructions to authors) or as the full protocol, provided the information reflects the most recent version. This information will be published as a supplemental file, if the manuscript is accepted.
In contrast, JAMA requires authors of manuscripts reporting clinical trials to submit trial protocols and the complete SAP, along with their manuscripts. If the manuscript is accepted, the protocol and SAP will be published as an online supplement. There is no mention in the journal’s instructions on whether redactions are acceptable.
While many other top-tier journals requesting copies of protocols and other documentation for peer review do not specify whether redacted documentation is acceptable, it is worth noting that ICMJE recommendations are explicit on editor and reviewer responsibilities to keep information confidential. Supplemental information, such as a protocol, which has not been redacted and is being provided to support peer review, is confidential and should be treated as such by any ICMJE member journal, editor, or reviewer. This confidentiality has been long-accepted practice by the journals, and in fact, ICMJE recommendations state, “Manuscripts submitted to journals are privileged communications that are authors’ private, confidential property, and authors may be harmed by premature disclosure of any or all of a manuscript’s details. Editors must also make clear that reviewers should keep manuscripts, associated material, and the information they contain strictly confidential.”
Elsewhere, the Committee on Publication Ethics (COPE) Code of Conduct also reminds editors to ensure that material submitted to journals remains confidential while under review.3
Considerations for Content Redaction
The content of a protocol needing redaction will depend on the development stage of the product, and what information is in the public domain or covered by patents.
- For early development products, details about the active pharmaceutical ingredient and formulation would not generally be disclosed prior to submission of the first dossier. Otherwise, sponsors may wish to redact information relating to: rationale for the study, discussion of any novel concept arising from the research, and details of proprietary ratings scales and tests.
- As products move through the development stages towards registration, more information has become public and less information needs to be redacted.
- Sponsors may also decide to redact information relating to personal information, such as addresses and phone numbers for investigators, sponsor staff, and suppliers, and the investigator signature pages.
Redactions should be kept to a minimum and never compromise the assessment and disclosure of safety information. Sponsors will usually have standard operating procedures providing guidance on redaction procedures for their organization.
Key Takeaways for Medical Publication Professionals
- For manuscript submission to any ICMJE member journal, prepare to also submit the protocol and amendments (and SAP if not in the protocol).
- ICMJE member journals are bound to keep confidential the information that is submitted to a journal to assist peer review.
- As a condition of acceptance, expect that you will need to include a copy of the protocol in an appendix or a link to a suitable data repository where the documents may be accessed.
- Posted documents may be submitted with reasonable redactions of proprietary and personal information; plan ahead for any necessary redaction procedures to meet submission timelines.
- Consider including a separate CONSORT flow diagram even when not required by the journal, as the diagram can guide the reviewer through the study design.
- … And finally, start thinking about those data sharing statements, since they will be needed for submissions to ICMJE member journals starting July 1, 2018.
1. ICMJE recommendations. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/responsibilities-in-the-submission-and-peer-peview-process.html
2. Data sharing statements for clinical trials: A requirement of the International Committee of Medical Journal Editors. http://annals.org/aim/article/2630766/data-sharing-statements-clinical-trials-requirement-international-committee-medical-journal
3. Committee on Publication Ethics. http://publicationethics.org/files/u2/New_Code.pdf