We all are searching for answers to questions like:

• What can we learn from patients that we don’t already know from their doctors?
• Are we actually allowed to talk to patients?
• How can we overcome mistrust of the industry?
• How can we work efficiently with voluntary patient representatives who don’t know about our daily job requirements?
• What’s the added value for business and how can I prove this to my management?
• Who shall actually manage this?

It’s about the what and how! This is what we hear from industry:

• So far, only limited guidance exists through national and international laws, codes of conduct and other materials available (e.g. DIA Considerations, EUPATI Guideline for collaboration in industry led R&D).
• Systematic validation and standardization will take time.
• We need an overview of existing guidance, expertise and networks.
• We need flow charts, tools and checklists wherever possible.
• We need practical examples and case studies.
  
• We need Dos and Dont’s in collaborating with patients.
• We need help with “selling” the value of patient engagement internally to get budget and resources allocated.

The Patient Engagement Guidebook is an “easy-to-use and easy-to-find” practical guide that:

• Is intended to be complementary and supportive to other similar initiatives.
• Is focused on the industry perspective, though patient experts have helped to bring in their perspective.
• Deals with typical and frequent challenges related to patient engagement in practice and across the value chain.
• Contains tools and checklists.
• Consists of case studies covering real scenarios around topics like:
  • Mapping the players: identifying which patients to ask for collaboration for which purpose
  • Disease understanding: conducting interviews and focus groups with patients about their patient journey
  • Patient advisory boards: how to create and work with them
  • Trial design: challenging, discussing and co-creating clinical endpoints, surrogate parameters, patient reported outcomes and clinical trial protocols
  • Co-creation along the value chain
  • Patient insights research and user tests with patients
  • Legal and behavioral compliance: how to approach this sensitive matter regarding the interaction with patients
  • …and much more

Several companies, members of HollandBIO and others, have helped with their input and critical review of the concept, the usability of the tool and specific content.

Additionally, important national and international materials created with the help of experienced patient organizations are consistently being referred to. Several patient experts have been asked to support the Patient Engagement Guidebook with their guidance in order to strengthen actual collaboration capabilities with the industry.

• A “book” for one-time reading.
• Replacing or re-inventing the strong materials that already exist: among others those from EUPATI, PFMD, CCTI, PCORI, ADAPT SMART, EPF, STAMP, and many more.
• Competing with or questioning ongoing and future international multi-stakeholder approaches like the EU IMI 10th call.
• Specifying or interpreting laws or codes of e.g. EFPIA or the national industry association’s codes for interactions with patient organizations.
• A one size fits all approach or a standard operational procedure.
• A full solution provider to a company’s specific situation.

• This guide can help in a variety of concrete, practical situations. Use it when there is a specific project ahead or ongoing.
• Search and find similar situations to yours via the case studies.
• If this still doesn’t help, contact admedicum. We are happy to provide free advice if it’s simple or discuss ways to support if more complex.
• Use the pdf download functions for tools and checklists.
• Use the feedback features! You can help to make each version better and more meaningful for patients and industry altogether!