Key Wins for Patients in GPP Update
Angela Sykes
Catherine Skobe
Trishna Bharadia

ew, updated Good Publication Practice Guidelines for Company-Sponsored Biomedical Research (GPP) published by the GPP Steering Committee in September 2022 aimed at supporting publication of company-sponsored biomedical research and includes important new topics such as working effectively with patients.

Global Forum previously overviewed the concept of GPP and the impact of this 2022 update on practices in 2023 and beyond. In the following Q&A, three experts explore patient-focused aspects of this GPP guideline: Angela Sykes, an author of the update; Catherine Skobe, from the expert review panel for the update; and international patient advocate and patient engagement advisor (and former Global Forum Patient Engagement Editor) Trishna Bharadia.

Angela Sykes (AS): Trishna, what are the key wins from a patient perspective in this latest GPP guidance?

Trishna Bharadia (TB): The key win is that this update has a strong patient focus. The widened scope includes plain language summaries and other types of enhanced publication content. The guidance actively encourages plain language summaries for every publication, which will get industry thinking about how this can broaden and improve access to scientific information for patient communities. The focus on inclusivity is explicit, not implicit. It’s overtly about inclusiveness. The fact that patients are mentioned as a group that can be included in the publications process as an equal stakeholder is a major win.

Just as important, but maybe less explicit, a win is that this version provides more guidance on the “how-to,” which is often a stumbling block in patient-centricity. Organizations understand the value of including patients but stop short of including them because they don’t know where to start or how to do things compliantly. Not only does this update recognize the importance that patients can have in the publications process, but it also provides advice on how to go about actually doing it. People are getting practical advice on how they can include patients.

Finally, this version of GPP makes it clear that presenting authors can be reimbursed for out-of-pocket expenses. This is important because I know patients (including myself) who have been unable to accept invitations to present posters at conferences because the sponsor has said they can’t reimburse expenses. It is now absolutely clear that this is allowed and can be done.

It is also clear that patients can be compensated for the time they spend on publication activities. This provides a much more equitable opportunity for every patient to be involved, if they want to be, regardless of their circumstances. We know that patient authorship is increasing, so we need to make sure from the start that it is equitable. The fact that there is now something in writing that can be referenced will make it easier for pharmaceutical companies to have internal conversations about it. Catherine and Angela: What are the key wins from the industry perspective?

Catherine Skobe (CS): GPP 2022 broadened the scope of scientific publications with a focus toward open science. For the first time, there’s a clear focus on improving accessibility and inclusion when examining all audiences and their needs. GPP’s expansion into different content, delivery formats, different geographies, and who can contribute to the content are key wins. This guidance aligns perfectly with the current and future trends we’re seeing in our field.

AS: GPP also expands on the central role of the publication professional in ensuring that other pharmaceutical company team members are educated on various aspects of publication management, ethics, and development, such as working with patients and patient advocates on the development of publications. The guidance empowers publication professionals to take the lead in ensuring that best practices in patient authorship are incorporated into company-wide standard operating procedures (SOPs), guidance documents, and templates. Ideally, we would like to see these publication professionals work with patient experts in addition to relevant internal stakeholders (such as legal, patient advocacy, and compliance) when developing these SOPs to make sure these policies and processes can be easily applied throughout the company and meet the needs of all stakeholders. GPP supports that central role of the publication professional.

TB: Angela, you were an author on this iteration of GPP. What were some of the drivers behind including patients in this iteration?

AS: As we’re all aware, over the past few years, there’s been an international movement towards greater patient involvement in all aspects of clinical research, from participating in the design of the research question and helping with recruitment to developing publications based on the study results. We’re seeing this throughout industry: Some congresses now have patient-authored abstract and poster tracks, and we’ve seen journals such as the BMJ encourage incorporating patients and the public in development of clinical publications. We’ve also seen biopharmaceutical companies developing processes and policies for the inclusion of patients as authors of company publications. The GPP authors wanted to ensure that this latest iteration was up-to-date with the times, so it was imperative to embed the importance of patient authorship and how to go about it. As you said, the guidance provides a practical approach to how to go about doing this. It took us years to develop this update, and we wanted to make sure that it was not only up-to-date with current practices but also forward-looking and providing tools that companies need to move forward and ensure that patient involvement in publications becomes even more mainstream.

CS: Has there been any feedback from patient organizations or communities about this update? Are there plans to involve patients in developing the next version of GPP?

TB: Patients who are already involved in publications and those who are aware of the update have welcomed it. I’ve heard others ask if there were any patients involved in authoring this version, so this is something to consider for the next update. I know there was at least one patient reviewer, but I’m not aware that there were any patient authors, and this is something to also consider for the future.

The guidance states that a GPP task force might be required for regular reviews and updates and that this kind of a task force should maintain a balance of representatives from industry editors, communications agencies, publishers, and academia. But the patient voice should also be included if such a task force was to be established.

AS: There hasn’t been any formal feedback that I’m aware of. However, the International Society for Medical Publication Professionals (ISMPP) has an advocacy and outreach committee, which has a patient advocacy workstream. GPP authors plan to engage with that workstream to see how we can engage with patient advocacy organizations to increase awareness of GPP and get feedback. We have not started discussing including patients as authors in the next iteration. I think that GPP would greatly benefit by including patients as authors going forward. When it comes to authorship, people from various organizations are invited to apply to be an author. I certainly hope that we have several applications from various patient experts and that we will have patient authors on the next iteration.

TB: While it’s important that we increase awareness among patient organizations and advocates that the new iteration of GPP is here and has a patient focus, it’s important to raise awareness about this guidance not just in patient communities but also in different pharmaceutical industry functional areas which may be indirectly involved in publications but aren’t part of the publications function. We know that patients need to be involved much earlier in the process than the publication stage to fulfill the criteria of being an author. Therefore, functional areas such as medical affairs, clinical development, and patient advocacy, which may be working with patients who could potentially be involved in the publications process, should also be made aware of at least some of the aspects of the guidance so that they are able to consider which steps should be taken to include patients in the process before it becomes too late. When it’s time to publish, it may be too late to raise awareness about the guidance.

AS: I agree: When you get to the point where you’re ready to publish, and all the data analysis and interpretation has been done, then how is it possible to add somebody who wasn’t involved up until that point? What some companies have done (and other companies should consider doing) is establish a central function with representation from clinical development, medical affairs, patient advocacy, and other functions that focuses on patient-centricity. This group should meet on a regular basis and share knowledge and best practices. This type of forum can ensure that all relevant functions across an organization are aware of the value of including patients in the publication development process when appropriate, that there is a process in place for how it can be done, and that the importance of involving patients from the very beginning is recognized.

But what wasn’t addressed in this version, Catherine, and what should be addressed in the next?

CS: There was a lot of ground covered in GPP 2022 regarding patient involvement in publications that will be very new to many organizations that haven’t yet started on this path. Execution of those best practices will generate details that should be added or improved upon in the next iteration. We have a lot to learn from what was just released, and I expect these additions will most likely include details around how patients get involved versus the what and the when. Possibly the guidance will become more granular based on the level of publication expertise from patients we’re working with, in the next iteration or in the interim through best practice recommendations formulated by individual companies and/or patient groups or professional organizations such as DIA, the International Society for Medical Publication Professionals (ISMPP), the Medical Affairs Professionals Society (MAPS), and the American Medical Writers Association (AMWA).

TB: I wonder whether it would be valuable for the next iteration to have a specific section, perhaps in the supplementary material, dedicated solely to working with patients, because right now it’s spread throughout this update. I like the fact that patients have been embedded throughout, but I wonder how easy it is for organizations to implement some of these things, because they might miss them. Organizations still tend to see working with patients as a separate process, and grouping everything together might make it easier. We’ve all heard, “It’s too difficult.” So we need to make it as easy as possible for organizations to implement the guidance. Having a specific section around working with patients, where everything is all grouped into one place, might do that. We need to make it easy for patients to be involved in publication activities. Highlight specific tools and resources so that organizations have as much help as possible all in one place.

AS: What advice do you have for organizations that haven’t worked with patients as authors but would like to start doing so based on the new GPP guidance?

TB: Be prepared to work collaboratively. You’ll be working with not just patients but with other departments: Legal and compliance, patient advocacy, medical affairs, clinical development; draw on their expertise about working with patients. Find out what they’re doing. How can we make sure there is an embedded process, end to end, that enables patients to be authors? Whilst this guidance is fantastic, it doesn’t necessarily prepare someone for working with patients if they’ve not done so before. Remembering things like asking patients what will make things easier for them, using easy-to-understand and clear language, getting to grips with good patient engagement practices, will stand you in good stead. Patient authorship is discussed a lot in industry, so seek out conferences that include sessions about it so you can learn best practices, what other organizations are doing, what their challenges are, and what they’re doing well (or not).

CS: Listen to the patients you’re working with. Be supportive in helping them navigate your company’s policies and procedures. The processes are going to vary depending on which company you’re working with, and it can be quite complicated. Be respectful of their time. Be flexible. We know they or those they are caregivers for have conditions that can impact their scheduling. Be mindful of that while planning. Be particularly patient with any form of technology that your company may use for communication or writing, because patients may not be familiar with it and this could impact timelines. Most importantly, we need to appreciate their contributions. They make our science and research more relevant to those whose lives and outcomes we intend to improve.

AS: We have to make the process as seamless as possible for patients and the company because if it’s difficult to do, then no one’s going to want to do it. Companies should develop clear patient authorship requirements, processes, and tools in partnership with patients to ensure that the experience is good for them. For example, our company worked with a diverse group of patient experts, legal, finance, compliance, and other colleagues to develop a global patient authorship process. We also partnered with patients to develop a Patient Author Welcome Kit that explains what to expect when working with our company on publications.

Getting input from patients made us consider things that we may not have thought about. For example, our patient travel and expense policy now explicitly states that if a patient needs a caregiver to travel with them, they can request support for that. All patient-focused content that is part of the guidance (e.g., contract template, travel and expense policy) follows plain language best practices so that it’s understandable not only to a lawyer but to a layperson.

Working in a collaborative manner and getting patient input from the beginning will really help when implementing this process, because then it will be seamless not only for the patients but for the colleagues at the company who are using these tools and working with patient authors. The more we can do that, the better it will be.