As a fundamental step, any effort to include patient voices must ensure that the needs of the patient community are consistently respected. Although such communities will be committed to helping to build a trusting relationship, we must also recognize patients’ often limited resources and the emotional challenges of sharing personal stories and insights. We must work to establish relationships centered on listening to patients and caregivers.
“Understand their viewpoints and give them space to educate you. Offer opportunities to ask questions whilst also actively listening. Respect their other commitments.”
Sumira Riaz, Center of Excellence Lead, Patient Engagement at OPEN Health
Never overlook or rush these seemingly simple first steps. Trust and transparency are crucial to effective partnerships with patient communities and patient-advocacy groups. “Establishing trust and transparency must start with the first interaction” said Alex Dubois, Senior Vice President for Patient Engagement at OPEN Health and a board member of the CARES Foundation, the only patient-advocacy group dedicated to the congenital adrenal hyperplasia community.
“[The] industry needs to be honest, and how they engage with patients and advocacy groups should mirror where they are in the drug-development process. Patients and their families don’t want to get too deeply involved if a company’s program is still early stage. Don’t ask for too much early on; manage expectations; make sure your goals align.”
Alex Dubois, Senior Vice President for Patient Engagement at OPEN Health and a Board Member of the CARES Foundation
It is also important to establish expectations and clarify roles and responsibilities upfront. “You don’t want to get someone on board, have them commit fully, do a lot of work, and then have to go back and tell them you can’t find somewhere to publish this work,” Riaz said. The industry should identify appropriate outlets and understand authorship guidelines before recruiting patient authors.
Many patients have limitations that affect their ability to access and process the written word. Accessibility should be at the forefront of publication planning, particularly with patient authors; it is our responsibility to work with these authors to identify which methods of communication are most suitable for them and facilitate this. Where needed or requested, text should be provided in the local language, in appropriate fonts and sizes, and include audio options.
We wanted at this point to acknowledge the topic of remuneration of patients to recognize their time and expertise in contributing to publications. Given the evolving landscape, and individual company positions toward it, we will reflect on the different perspectives and observe developing consensus.
Understandably, individual pharmaceutical organizations approach this with caution because paying a patient to co-author a publication runs the risk of perceived or actual inducement and bias. However, from another viewpoint, relying on the goodwill of advocates to invest time and effort in supporting the development of publications is unsustainable and may well limit uptake of patient participants. Loss of income due to the time commitments toward the publication, or inability to participate for patients building a career in advocating for a disease, could lead to low levels of patient involvement in publications, with the loss of all the prospective insight and value that their perspectives could bring to our scientific understanding.
Given the validity and potential effect of both viewpoints, we must continue to build on the consensus that is developing to find an appropriate path toward resolution of this important topic. In the International Society for Medical Publication Professionals (ISMPP) working group on Plain-Language Summaries (PLS),1 it recommends: “Lay reviewers should be offered appropriate payment for their expertise and time.” In the 2022 Good Practice Publication (GPP) guidelines, it says: “Author agreements may state that authors will not receive payment in exchange for listing their name on a publication byline; however, this statement does not automatically disqualify from authorship professional medical writers or any other person earning a salary from professional activities that may confer authorship. Nor should such a statement be interpreted as a prohibition for compensating patients or other participants in publication activities, such as patient advocates or SC members, for their time.”2
This is an evolving landscape where we need to continue to collaborate to gain further consensus and confidence in developing consistent approaches. To note, and if it is deemed appropriate to remunerate patients, then it should always be based on fair-market value, and we must adhere to regional and local guidance on how to effectively and compliantly apply this. For example: https://nationalhealthcouncil.org/fair-market-value-calculator/
