As Brooke explains, the current problem is that there are so many patient engagement initiatives from industry, advocacy groups and others, but the approach is very fragmented – not only geographically but also in terms of the maturity of the concept. This fragmentation means that patient-centric medicine and better patient outcomes – with their inherent benefits for all stakeholders, including research, clinical regulatory and value aspects – are hard to achieve.

There is increasing willingness on the part of stakeholders to create effective patient engagement, representing promising seeds for growth. Brookes suggests, though, that, far from being planted and nurtured, these seeds have instead been hampered by a lack of structure and consistency and duplication of effort instead of learning from and building on existing good practice. “What we need is fertile ground in which all these initiatives can be integrated and synergised further to create long-term, viable concepts,” he adds.

This is precisely where PFMD’s approach can produce the appropriate environment in which these seeds can flourish. PFMD represents a neutral non-competitive environment where all stakeholders can work together in a safe environment that supports open dialogue, collaboration and alignment. Its additional mission is to activate the environment and the co-creation process to develop new solutions out of what exists today – to have an effective patient engagement ecosystem.

So, it’s not a case of reinventing the wheel, but rather about getting great initiatives on board, learning from their experience and seeing how they can be connected to other initiatives.

This is founded on four key steps:

Four steps:

1. Building knowledge – gathering information through: literature review; looking at existing initiatives; comparing existing frameworks; and integrating all the work and outputs produced through other efforts including for example the European Patients’ Academy (EUPATI).
2. This knowledge and information is submitted to multistakeholder focus groups who are taking an active role in building framework for patient engagement and beyond. This is the co-creation phase, with focus group participants providing their insight and expertise to identify good practice (and provide practical guidance on addressing gaps) and create a meta-framework for patient engagement.
3. PFMD will then define pilots, building and testing them with members and wider stakeholders; members can apply to test a specific methodology.
4. The creation of a practical toolkit for implementation of the meta-framework: this is a case of not talking simply about methodology on paper. It will consist of templates and resources, together with expertise and coaching to help an organisation move from theory to practice.

At the heart of the framework co-creation is a Global Mapping and Networking Tool, which maps and categorizes the diverse initiatives already in the patient engagement landscape and allows for enhancement through networking and collaboration. This is a unique tool where contributors can share initiatives and expertise in a structured platform. Technically this uses a form-based system to capture information and also gathers information across different categories of patient engagement. The tool gives you an overview of patient engagement activity – for example by geography, scope or maturity – but more importantly helps you see where each initiative ‘fits’ in the landscape. Stakeholders will also be able to submit a call to action, which then encourages people to share their activities and get insights from others.

The tool is accessible to members and non-members alike ‒ allowing for high visibility – and is searchable. This means that if you’re looking for an organisation with patient engagement experience specifically within oncology clinical trials in, say, Germany, you can locate them with the tool.

The next step is to develop the people networking features of the tool so that individual expertise is more searchable, offering the ability to pinpoint, for example people with regulatory experience. This will provide further insights for evidence-based patient engagement.

There is also evidence of significant flexibility in the system. When users saw the categorisation of different patient engagement areas, they probed whether it would be possible to develop an overview map for a single organisation. PFMD delivered, with a new tool: the data can now be applied to one organisation alone, which then offers a patient engagement portfolio management tool, allowing organisations to monitor what they do.

Currently, PFMD already has 157 initiatives entered on the tool, hosts 170 people as patient engagement leaders and 111 organisations that undertake patient engagement – and all this has been achieved in only 6 months.

So, what next? Well, PFMD has been very active in the EU and US and is now looking to extend its engagement to Asia, Latin America and Africa. It is also striving to increase the diversity of membership, which consists currently of 9 pharmaceutical companies; 11 patient organisations; 1 health technology assessment organisation (HTA international). “We want to be as inclusive and representative of the diversity of stakeholders in patient engagement as we can and are looking for device manufacturers, regulators, healthcare professionals and investigators, among others to actively participate. We encourage anyone or any organisation committed to meaningful patient engagement to join PFMD and contribute to co-creation of the meta-framework,” says Brooke.