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Patient Engagement in early dialogues-tools and resources for HTA bodies

Early dialogue with regulators and HTA bodies is a well-established process in which medicines developers have the opportunity to discuss their research plans and gain advice and feedback on their planned approach. Patient engagement and involvement in these dialogues is needed to ensure that patient experience, perspectives and knowledge is captured as part of this dialogue.

Engagement of patients in these early dialogue processes is an emerging discipline among HTA bodies, with a range of methods being piloted and used.

There remains a clear need to provide adaptable tools and resources to simplify patient engagement processes for HTA bodies and provide guidance on suitable methods and approaches.

The tools in this resource are aimed for use by HTA bodies and created for adaptation and use.

Patient engagement agreements explained

Collaboration between pharmaceutical companies and patient advocates should be based on contracts signed by both parties covering various types of activities such as consultancy, collaborations, speaking engagements and advisory boards. These contracts define the terms and conditions of the engagements, covering such matters as confidentiality, intellectual property, copyright, data protection, compensation and other responsibilities of both parties. They typically also contain provisions, mandated by the pharmaceutical industry or regulatory authority codes, designed to ensure an appropriate relationship between a patient and the engaging partner. In the past, the complexity of these agreements has often been challenging for the patient community and in particular patient advocates to work with due to the contracts being long, difficult to understand and sometimes containing ambiguous clauses.

This work aims to help the patient community to understand the agreements they might need to review when collaborating with pharma. The digital tool shows the reference agreements co-created by WECAN (under RAPP project) with additional explanations co-created and reviewed within a multi-stakeholder task force in PARADIGM.

Please test the prototype digital tool and review the explained agreements and let us know how we can improve to increase understanding of these legal documents.

Code of Conduct

This “Code of Conduct for all stakeholders involved in patient engagement activities within medicines development” is intended to be a stand-alone document that highlights, summarises and refers to the key patient engagement principles, rules, and recommendations for collaboration presented in the different PARADIGM documents in a comprehensive, understandable format.

It was jointly developed by a large team of experts from the patient community, pharmaceutical industry, regulatory authorities, HTA bodies, academia, and not-for-profit organisations aims at reducing the risks for conflicts and hurdles in patient engagement activities by defining the conditions for fruitful collaboration.

The consultation is divided into 2 sections. In section 1 you are invited to give feedback on the usefulness and usability of the document and in section 2 you have the possibility of providing in-depth comments on the content. Please note that you can respond to this consultation by responding to section 1 only.

Note that you can save your answers and continue at a later stage. For saving your answers you will need to click on the “Save and continue later” button. A link will allow you to re-enter the form.

Community Advisory Board – Guidance document and templates

Community Advisory Boards (CABs) are an innovative concept, developed some decades ago in the United States and more recently in Europe, to establish long-term relationships between the patient community and industry in order to encourage patient engagement and input in the medicine research and development lifecycle.

There are a number of patient communities working with CABs. Although other ways of collaboration between patients and industry exists, a key element of this approach is that CABs are initiated and driven by the patient community and their work is independent from industry.

The PARADIGM CAB toolkit contains 8 different tools. The toolkit has been developed collaboratively by people from the patient community and from industry both with and without experience in CABs and is intended for patient communities and pharmaceutical companies interested in setting up, running, or collaborating with CABs.

Enhancement of the EUPATI industry guidance

The EUPATI Guidance for Patient Involvement in Medicines Research and Development (R&D); Guidance for Pharmaceutical Industry-Led Medicines R&D was published in Frontiers in October 2018. During the PARADIGM project, further expansion of specific sections of EUPATI guidance was required.
Set of tools for consultation:

Enhanced EUPATI guidance: suggested working practices;
Suggested working practices checklist (Appendix 1 of the enhanced EUPATI guidance on suggested working practices);
Enhanced EUPATI guidance: events and hospitality;
Events and hospitality checklist (Appendix 1 of the enhanced EUPATI guidance on events and hospitality).

The working practices guidance provides more detail on how an interaction could be defined with specific actions and describing what should happen during pre-engagement planning and discussions to ensure mutually beneficial interactions with adequate preparation.
The events and hospitality guidance provide more detail on the level of attention needed when arranging patient engagement activities to ensure patients have the best experience.

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.
The following set of tools aims at:

1) 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

2) highlighting how each stakeholder could better prospectively manage competing interests, and

3) to help avoid/minimise conflict of interest by suggesting risk mitigation strategies.

Guidance for Reporting and Dissemination of Patient Engagement Activities

The complete and reliable reporting and dissemination of all patient engagement (PE) activities are essential to ensure transparency and enable continuous broad learning for all relevant stakeholders undertaking in PE activities. Progress is best achieved through an agile learning ecosystem.

The purpose of this tool is to address issues specifically related to the reporting and external dissemination of PE activities in the public domain. It builds upon relevant principles of reporting clinical trial data, ‘case study’ formats of PE activities on open access platforms, and standardized publishing of PE projects in journals.

In doing so this document is intended to provide participating organisations with guiding principles, a planning checklist, and a practical template to move beyond anecdotal reporting of broad PE strategies, to promote consistent, timely, accessible, and discoverable PE activities as part of a learned dissemination and communication continuum.

Recommendations on how to find the right match for the right patient engagement activity

These documents aim to provide recommendations to all stakeholders to identify the right match for the right patient engagement activity. They address the topics to consider and a check list of the elements to consider before engaging with a patient organisation to work on a patient engagement activity. It is complemented with a table of competencies, as a tool for individuals to self-assess their own competencies, as well as during the co-design phase to identify the level of competencies required for the activity.

We need your feedback on the usefulness and usability of these documents.

Recommendations on required capabilities for patient engagement

The present document aims to provide recommendations on a set of capabilities and competencies (understood as knowledge, skills, and behaviours) that each stakeholder should aspire to have in place in their respective organisation in order to be able to undertake the planning, implementation, and reflection of PE activities.

The objective of the recommendations described here is to strengthen “system readiness” across all stakeholder groups to ease and systematise the implementation of patient engagement by identifying the capabilities required for patient engagement. Each stakeholder can use these recommendations to analyse their own organisation’s capabilities and consider the elements described to further develop or adapt the capability model existing in their own organisations.

PARADIGM is receiving funding from the Innovative Medicines Initiative Joint Undertaking 2. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

PARADIGM Tools – Public Consultation