Soma Das, Assistant Manager, Medical Review

Good Publication Practice 3 (GPP3) in Practice: A Road Map to Ethics & Transparency in Medical Communication

Soma Das

Good publication practice (GPP) guidelines advocate clear, timely, transparent and high quality reporting of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. Good Publication Practice 3 (GPP3) guidelines published in August 2015 retain the core values of GPP; additionally, the latest update reflects changes in the medical publications environment and strengthens the principles and practices described in the earlier versions. The revised recommendations largely cover publications in peer reviewed journals and scientific congress presentations and are meant to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements.

A Guide for the Industry
Primarily, GPP3 enlists ten key publication practices which are intended to support the six core principles of GPP: integrity, transparency, completeness, accuracy, accountability and responsibility. These can also serve as a checklist for the authors and medical writers. Some of the important additions in GPP3 are:

  • A revised definition of authorship, as made by the International Committee of Medical Journal Editors (ICMJE) and a more practical guidance to outline recommendations around common authorship issues.
  • Recommendations to companies on internal policies and procedures to document the complete process of publication/abstract/presentation development and to ensure maintenance of shareable data that could be requested after publication. These documents need to be retained according to the sponsor company’s policies or procedures, or regulatory agreements that may exist, and in a way that can be audited. A list of such recommended documents include:
    • All study-related data that support the publication (in a shareable format);
    • Agreements to participate in the publication development process (e-mails, and minutes from author meetings or teleconferences);
    • Details of intellectual input and other contributions, including comments on drafts;
    • Versions of the draft to document how comments were incorporated;
    • A list of contributors other than authors who were allowed to review or comment on drafts; the decision on who would submit the abstract or manuscript;
    • Approval from authors of the final version to be submitted and the version to be published;
    • Disclosure from all authors and a contributorship listing (that is, who did what on the document);
    • Journal or congress peer-reviewer comments and the authors’ responses.
  • Ghostwriting (non-acknowledgement of medical writers) has been addressed elaborately in GPP3. Though the incidence of ghostwriting is cited at 34% among members of the European and American Medical Writing Associations, there is a 44% reduction in the rate of manuscripts with undisclosed contributions between 2005 and 2014.1 The GPP3 recommends that the contributions of medical writers, their funding sources, and any other potential competing interests must be disclosed. They also encourage journal editors to ask authors to complete a checklist to ensure that ethical guidelines have been followed and any writing or editorial assistance is appropriately acknowledged.
  • Sections have been added on data sharing and plagiarism which again requires involvement of medical writers.
  • Another new feature of GPP3 is positive assertion. While still a voluntary guideline, the tone of GPP3 is more confident than that of GPP2 – many of the statements that were prefaced by ‘we recommend’ have been replaced with assertions about what companies, investigators and writers ‘should’, or sometimes even ‘must’, do.

Publication Ethics Requires Planning
As part of a best practice, it is important to ensure adequate documentation and tracking of all stages of the manuscript development, author agreements, data checking and approvals (includes acknowledgements and citations). A publication plan that includes features such as Study Data Management, Project Workflows & Management, Automated Spend Tracking, Task Notifications & Alerts, Author Documentation Compliance, Reports & Dashboards is ideal. In environments where publication planners are not readily available, authors should keep records of these activities. The key aspects of a formal publication plan are:

  1. Developing and automating periodic update of the publication plan that accounts for anticipated publications and their timing on a regular basis
  2. Integrating a data dissemination plan that includes any public release of clinical data (for example, to trial registries or the press)
  3. Tracking of time required to perform all necessary tasks including reviews, plagiarism check, and reference check
  4. Facilitating data interpretation and discussion regarding authorship to ensure that actual practice meets the scientific and ethical standards of all professionals involved in discussions and authoring

GPP3 Potential Challenges and Solutions
All clinical trials are considered to be ‘medically important’ for publication. GPP3 recommends that
“findings from all clinical trials (including non-interventional studies involving human participants) be
made public, ideally by publication in a peer-reviewed journal, regardless of whether the findings are
positive, negative, or inconclusive or whether the studied intervention is investigational, is licensed, or
has been discontinued or withdrawn from the market”. The International Society of Medical Publication
Professionals (ISMPP) recommends some measures to overcome potential challenges in peer-reviewed
data disclosure, even in less-than-ideal circumstances.

A few examples include:

  1. For data which gets superseded by a larger study: authors can publish both data sets in a combined publication, clearly identifying both trials.
  2. For positive, confirmatory data/data lacking novelty: authors are advised to select appropriate target journal or use open access journals.
  3. For negative data: there are few specialist journals which may publish, however the journal choice may not meet authors’ expectations.
  4. For studies funded by unrestricted grants: include commitment to publish in contract by the investigator.
  5. There is still a grey area regarding publication of ‘Health Economics’ data: select a HEOR journal or even a non-HEOR journal, which may commonly publish this type of data.To avoid confusion regarding journal preference: discuss with authors at project outset; identify a second and third choice at the beginning of the project; submit a pre-submission enquiry; express intent to publish at project outset
  6. For easy access by primary healthcare professionals: publish in an open access journal
  7. For access by non-native English speakers: include a lay summary or present at local level

Future Need
GPP3 goes on to state that “not all studies produce publishable data. In such situations (for example, when the data are of limited scientific or clinical value or in the case of multiple journal rejections), posting results on a public website, trial registry site (for example, ClinicalTrials.gov, or the European Clinical Trials Database [EudraCT]), or data repository may be an option for disclosure”. There is a need to investigate other platforms such as an open publishing platform to widen the circulation of clinical data and thus improve transparency.
Another implication is sharing of patient-level data during publication. The ICMJE has directed its member journals to consider publication of a clinical trial report with the following conditions2:

  1. As of July 1, 2018, manuscripts submitted to ICMJE journals reporting the results of clinical trials must contain a data sharing statement.
  2. Clinical trials that begin enrolling participants on or after Jan 1, 2019, must include a data sharing plan in the trial’s registration.

One of the recommendations from a few stakeholders is to make data-sharing requirements applicable for academics, universities and noncompany-sponsored medical research which will generate a large volume of work for the medical writing industry.

Role of Medical Writers and Medical Writing Service Providers
Between 2009 and 2014, 185 abstracts were submitted to conferences, 164 presentations were made, and only 4 (less than 3%) of these got published (from ISMPP Annual Meeting abstract lists).3 In addition, ~60% of controlled clinical trials and ~50% of all studies with other types of study design presented as abstracts at biomedical conferences are eventually published in full.4 ‘Lack of time’ has been cited as the primary reason for non-publication; this has also been reported by a systematic review.5 Authors require extensive support from statisticians and medical writers to plan, write and publish their results in a peer-reviewed journal. A study found that medical writing support is associated with increased quality of randomized-controlled trial (RCT) reporting, both in terms of language and adherence to CONSORT guidelines.6

To summarize, while investigators, clinicians and sponsors do understand the importance of disseminating research findings—lack of time and skill becomes a major barrier. Medical writing service providers can help timely, transparent and quality reporting of research data.

References

  1. Cindy W. Hamilton and Adam Jacobs. Ghostwriting prevalence among AMWA and EMWA members (2005 to 2014). Medical Writing EMWA, March 2016.
  2. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. Lancet. 2017 Jun 10;389(10086):e12-e14.
  3. Luke C. Carey, Serina Stretton, Charlotte A. Kenreigh, Linda T. Wagner, and Karen L. Woolley. High nonpublication rate from publication professionals hinders evidence-based publication practices. PeerJ. 2016; 4: e2011.
  4. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev. 2007 Apr 18;(2):MR000005.
  5. Scherer RW, Ugarte-Gil C, Schmucker C, Meerpohl JJ. Authors report lack of time as main reason for unpublished research presented at biomedical conferences: a systematic review. J Clin Epidemiol. 2015 Jul;68(7):803-10.
  6. Gattrell WT, Hopewell S, Young K, Farrow P, White R, Wager E, Winchester CC. Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. BMJ Open. 2016 Feb 21;6(2):e010329.