Involving Patients as Authors of Company-Sponsored Journal Publications
Part A—Patient and Industry Perspectives
Dawn Lobban
Envision Pharma Group
Richard Stephens
Research Involvement and Engagement, BMC
Veronica Porkess
UCB Pharma

atient authorship of peer-reviewed publications is increasing, with patients not only presenting their own or academic research, but also participating as co-authors of pharmaceutical company-sponsored research. In this two-part series we:

  • highlight the drivers and value of involving patients as authors from both the patient and industry perspectives (Part A), and
  • discuss how journals are evolving to facilitate inclusion of the patient voice in peer-reviewed publications and extend the reach of publications to lay audiences (Part B).

Drivers, Opportunities, and Barriers for Patient Authors

Most stakeholders recognize the value of partnering with patients in research, including company-sponsored studies. Patients provide unique, valuable insights that can enhance understanding of their lived experience, identify unmet patient or caregiver needs, improve the design of clinical trials, and optimize care. This increase in engagement with patients in research is increasingly reflected in peer-reviewed publications, with a growing number of publications including patients as co-authors. In addition to providing valuable input into medical research, many patient partners can, and should, have the opportunity to co-author research and can in fact fulfil the International Committee of Medical Journal Editors (ICJME) authorship criteria. Those who do are often driven by a wish to be recognized for their research contributions and a desire to communicate their experiences, and those of other patients, to multiple audiences to improve clinical practice (Figure 1).

However, not all patients can or wish to author peer-reviewed research publications. To be successful, patient co-authors may have to overcome several barriers (Figure 1). Often, the greatest barrier is a lack of familiarity with the peer-review process and academic language used in research publications. Managing illness and treatment side effects and maintaining energy levels may also present hurdles that are difficult to overcome. Other barriers are more societal and include juggling job demands or family commitments and accessing technological resources to facilitate collaboration or attend online meetings. Such barriers can result in a lack of confidence to co-author articles alongside experienced academics. Furthermore, some patients may not wish to be identified for privacy reasons and to avoid any stigma that may be associated with their condition.

Opportunities and barriers experienced by patients partnering as authors
Figure 1. Opportunities and barriers experienced by patients partnering as authors.

Optimal Co-Authoring Between Pharmaceutical Companies and Patient Partners

As patient engagement evolves throughout the drug-development lifecycle, opportunities for patients to participate in and co-author company-sponsored studies will increase. Pharmaceutical companies have recognized the need to co-author manuscripts with patients to make their published work relevant and accessible to a broader audience.

Indeed, one company recently established a Patient Collaborative Board, whose objectives include enhancing partnerships with patients in the development of scientific publications. A key output of this group is enterprise-wide patient authorship guidance, designed to enable patient co-authorship of publications across the company. The guidance includes potential author identification, contracting, collaborating, and reimbursement. Training for employees on how to implement the guidance has also been developed.

A recent publication, led by two patient authors and supported by another company, demonstrates the value of patient insights to better understand their lived experience, especially in rare diseases. Such studies can teach us about how industry can best partner with patients in research and publications. Key learnings for industry from this study, in which two of the authors of this article were involved (DL and VP), include the following:

  • Liaise closely with internal compliance teams from the outset and throughout the study.
  • Collaborate with patient partners who have relevant insights, interest, and time to invest in the study, and the confidence to express opinions.
  • Schedule sufficient time to allow patient partners to manage other commitments in their lives.
  • For all research involving human participants, ensure that all relevant consent and ethics approvals are in place at the outset of the study, including signed ICMJE forms that confirm the proper reporting, and ethical preparation of research manuscripts submitted to peer-reviewed biomedical journals.
  • Access relevant resources and training to facilitate academic, company, and patient author collaborations.

Companies are also supporting the development of narrative reviews. Such reviews examine the current understanding of specific conditions and how best to improve patient outcomes by leveraging clinical practice, scientific literature, and the experience of patient authors, as illustrated in this example.

Evidence-Based Training and Resources to Enable Patient Authorship

It is important that those of us familiar with medical publications, including academics, healthcare professionals, publication professionals, and publishing experts working in the pharmaceutical sector, encourage and support patient authors to ensure that their voice is represented in the peer-reviewed literature. Indeed, evidence is growing regarding how best to partner with patients in this context. A recent systematic literature review outlines evidence-based recommendations for involving patients in peer-reviewed research publications. Guidance on how to engage in conversations about authorship at the outset of a study involving patient partners, to manage expectations and prevent misunderstandings, is provided in a helpful commentary. Training courses and resources co-created by patients and publishing experts that are aimed at anyone interested in patient-partnered publications are now available. One such online open access course from WECAN (Workgroup of European Cancer Patient Advocacy Networks) consists of four modules that collectively cover all stages of the publication process, from manuscript planning and writing to submission and addressing peer-review comments (Figure 2). In addition, the recently launched website provides practical guidance and resources for patient partners and publishing experts to facilitate collaborations.
Open access resources to enable patient authorship
Figure 2. Open access resources to enable patient authorship.
As opportunities for patient partners to co-author company-sponsored publications increase, high-quality, free and easy to access, evidence-based resources become invaluable. These resources, alongside company guidance, facilitate effective author collaborations, allowing the patient perspective to enhance the peer-reviewed medical literature.
References available upon request.