What happens in patient engagement when everyone is not on the same page? Elisa Ferrer and Maria Cavaller of Eurordis describe how they devised tools for the management of competing interests and conflicts of interest
Managing competing interests and conflicts of interest is of the utmost importance when planning, considering and conducting patient engagement activities in medicines research and development.
In this context, the interests of patients engaging in multiple, sometimes simultaneous activities with different stakeholder groups are under scrutiny by the engaging stakeholder. The impartiality of participants is essential to safeguard the process or activity in question and to ensure that there is no bias when it comes to decision-making.
“Having clear rules and mechanisms to recognise and proactively manage potential conflicts of interest is beneficial for all stakeholders,” say Ferrer and Cavaller, who co-led the PARADIGM working group that developed this necessary tool. This means highlighting how each stakeholder could better prospectively manage competing interests and helping to avoid/minimise conflict of interest by suggesting risk mitigation strategies. It also means raising awareness among patients (in their role of experts by experience) and the engaging stakeholder organisations of the consequences that the act of engagement might have on patients during multi-stakeholder interactions.
Although the importance of managing competing interests and conflicts of interest is common knowledge, data/work on this critical issue is lacking. An analysis of the gaps existing in current patient engagement practices by the working group confirmed that there were no detailed policy rules to handle competing interests or templates to help to fill in the declaration of interests.
The topic was then explored further during a dedicated workshop in which participants concluded that there was a need to raise awareness among all stakeholder groups about what competing interests are, the impact these might have on the patient’s ability to engage in the present and future interactions and how they can be effectively managed. In addition, declaring interests may be particularly difficult for patients as engaging stakeholders may require declaration of activities from several years back.
All of this helped them to devise a four-part mini-suite of tools:
- Raising awareness on managing competing interests in a multi-stakeholder environment: Guidance to patients and engaging stakeholders;
- Short guidance on managing competing interests and conflicts of interests;
- Log of patient engagement activities; and
- Educational scenarios on competing interests and conflicts of interest
PARADIGM has been an example of consistent co-creation across all project workstreams, and the working group for this particular tool enjoyed broad expertise. Regulatory authorities, like the European Medicines Agency (EMA), the Italian Medicines Agency (AIFA) and the UK Medicines Agency (MHRA), brought the specific views of regulators when approaching competing interests’ management. In addition, the working group had representatives in both industry and patient organisations who had also legal background and provided this much needed additional layer of expertise to the project. “The educational scenarios tool also benefited from the expertise of our academic partners to enhance the learning experience,” Ferrer and Cavaller explain.
They say that achieving the right balance between length and depth within the tools’ content has been probably the only challenge, in a very smooth co-production process. For instance, the short guidance was the result of discussing the need for a more practical tool addressing the essential points that each stakeholder group needs to know from their perspective on managing competing interests. This tool was envisioned as a complement of the main guidance document.
Ultimately, a better understanding of competing interests and conflict of interest management will result in more transparent engagement practices, hence building trust among all stakeholders involved. Early identification and management of competing interests is key to avoid a potential conflict of interests or to implement mitigation strategies, say the co-leaders, adding that this set of tools is designed to be used alongside many of the others in the PARADIGM Patient Engagement Toolbox.
“Having guidance on how to manage competing interests becomes important during the planning phase and particularly during the process of identification of patients for the activity. This set of tools also complement and expand the concepts included in the PE code of conduct. Potential conflicts of interest may arise during the conduct of a PE activity, as patients could be involved in several activities with one or more than one stakeholder simultaneously.”
The working group envision that the tools will be widely-used throughout the PE ecosystem, and they offer advice on how they could be employed by those working on patient engagement.
The ideal sequence would be to read the main guidance followed by the educational scenarios tool to reinforce learnings; however, it could be also the other way round, using the educational scenarios as a way to assess current knowledge base. The short guidance is a quick go-to tool that clarifies basic concepts, while the guidance could work as a reference document. The log of patient engagement activities is specifically intended to be used by patients to keep track of the activities in which they individually engage, and by the patient, organisations to keep a record of the activities in which the organisation has engaged and to help identify which experts would match the requirements of the engaging stakeholder (e.g. an expert free from interests with medicines developers to engage in a scientific advice procedure with a regulatory authority).
“For patient organisations, an updated log could also be useful to identify the type of relationship with the stakeholders they engage with, to help complete their annual activity report and to disclose the funding associated with a particular activity or project for transparency purposes, being mindful to adhere to confidentiality,” suggest Ferrer and Cavaller.