Giorgio Barbareschi from the European AIDS Treatment Group, Ana Diaz from Alzheimer Europe, Manuela Bruegger of Novartis and Daniel De Schryver of Janssen explaining how they devised a set of tools that would encourage patient groups and pharmaceutical companies to engage in community advisory boards
Although the community advisory boards (CABs) model has been successfully used for many years to engage patients in the development of new medicines, particularly in the field of HIV/AIDS, there remains limited information on what CABs are, how they contribute to research and how they operate.
Recently, and inspired by the work of the HIV community, patient groups linked to cancer or rare disease have been using CABs as a new platform to engage with industry partners in medicine R&D, and patient groups in other therapeutic areas have also shown a growing interest in CABs. Some of the patient communities and pharmaceutical companies interested in developing or engaging with CABs (or other stakeholders) are looking for concrete tools to guide them in starting or improving this interaction.
That’s where PARADIGM comes in. The guidance documents and templates are drawn up as part of this PARADIGM tool have been designed to respond to both patient groups and pharmaceutical companies interested in starting or engaging in CABs, explain Diaz, Barbareschi, Bruegger and De Schryver, who co-led the working group that devised this tool.
“The tools also support those who have been working with CABs for a long time and would like to consider ways to adjust to new needs, priorities and working styles,” they note.
Barbareschi, Diaz, Bruegger and De Schryver, note that the work has been conducted in a collaborative style by an authoring group composed of four people, two from the patient community and two from pharmaceutical companies. While there were different levels of background and experience on CABs, at least one of each group had extensive experience of organizing and/or participating in CABs. Ongoing input was then sought from other patient groups, pharmaceutical companies and academia within the scope of PARADIGM. In addition, when appropriate, other relevant organisations were invited to collaborate and provide information and feedback, add the co-leaders.
The CAB Guidance tool- was initially developed based on the expertise of the members of the authoring group, as well as drawing on existing information about CABs in the public domain and specific information provided by each patient community about their CABs. Different versions of the tool were shared with representatives of three patient groups (HIV/AIDS, cancer, rare diseases) and pharmaceutical companies and their feedback was also incorporated into the document.
Some of the subsequent tools were developed based on feedback, focusing on specific aspects of the Guidance document with the aim of presenting some of the relevant information in a more simplified and straightforward manner (e.g. comparative table, the checklist). Three tools were co-developed as part of a PARADIGM workshop in March 2020 and they expand on some of the topics addressed in the Guidance tool (e.g. briefing for representatives from pharmaceutical companies).
Barbareschi Diaz, Bruegger and De Schryver say the conversations that they had with patient groups and industry made clear that there are different needs in this area; although some organisations had quite a lot of experience in working with CABs, others were just starting or thinking about it.
“We, therefore, decided to develop tools which were flexible, pragmatic and easy to use by different stakeholders, at different times and contexts. We also had to face the challenge that different communities are working with CABs and although they share the same principles, they use different approaches in the way they operate. We were also very aware of the fact that different patient groups have different needs. We didn’t want to impose any model or suggest another new model, so we felt the best approach was to present different ways of working so that organisations could feel inspired by the different existing experiences and find their own way of working which would be suitable to the needs and expectations of their patient community,” they explain.
Widespread usability of the final tools is important and was a primary goal for each working group within PARADIGM. The authors say these tools can be used by patient communities and pharmaceutical companies working already with CABs or planning to work with them; while some of the tools will help to raise awareness of CABs and provide more information about this model, others are more practical and can help organisations in their planning.
“For example, some of the tools show how different communities have over the years addressed some relevant topics such as organising meetings, finding members or the resources that may be needed. Also, some tools are more reflective in nature and can help the organisation to identify the relevant questions for planning and running a CAB and think about what the best approach for them maybe and track this over time,” say Barbareschi, Diaz, Bruegger and De Schryver. There are also some very relevant tools for the industry with clear messages and hints to use when collaborating with CABs, they add.
An overarching aim of PARADIGM is to encourage and improve the involvement of patients and patient representatives in the development of solutions, and this particular tool epitomises that goal, concluded the team.
“We believe the CAB tool is one particular way, with a proven track record in HIV, by which close collaboration and ongoing dialogue between patients and the industry can be ensured.”