Practical How-to Guides for Patient Engagement

These guides aim to provide you with specific support in your patient engagement efforts, on key activities across the medicine development lifecycle.

The peer-reviewed publication “Co-creation of practical “how-to guides” for patient engagement in key phases of medicines development—from theory to implementation” is now published. Check it out.

Are you planning a patient engagement activity in the early discovery and preclinical phases of medicines development?

A specialised How-to Guide, co-created with experts, is here to support you.

Find out more Click here to find out more

Are you an expert in the development of a clinical outcome assessments (COA) strategy?

The first co-created and comprehensive How-To Guide on Patient
Engagement in the development of a Clinical Outcome Assessment (COA) is now ready-to-use.

Find out more Click here to find out more

Are you planning to engage patients in clinical trial protocol design?

A specialised How-to Guide, developed through a systematic co-creation methodology with experts, is here to support you in specific patient engagement activities.

Find out more Click here to find out more

Are you planning a peer-reviewed publication? Would you like patients to be able to access it and understand it?

Download now the first experts co-created How-To Guide for the development and dissemination of plain language summaries of peer-reviewed publications and conference presentations.

Find out more Click here to find out more

How-To Guide for Patient Engagement in the Early Discovery and Preclinical phases

This guide takes you step-by-step through an innovative process of identifying key patient partners, gaining important insights that help improve early research from unmet needs, developing research methodology and fostering important and long term partnerships.

The guide has been co-created by 36 people from 16 organisations.

More about the faces behind the project can be found here.

How-to Guide on patient engagement in the development of a clinical outcome assessment (COA) strategy

This guide will help you include patient engagement in the development of a COA strategy within clinical trials, with a specific focus on Patient-Reported Outcomes. This guidance aims to provide a basis for more meaningful and systematic engagement of patient partners at each of the critical milestones in the COA strategy development.

More than 22 diverse experts worked on developing this material, using a robust co-creation methodology.

More about the faces behind the project can be found here.

How-to Guide on patient engagement in clinical trial protocol design

The guide provides you with all the information you may need for patient engagement in clinical trial protocol design, in one place. It provides 4 key steps for patient engagement in this activity, alongside clear explanations on how to advance at every step of the way, common taxonomy, additional resources and guidance.

More than 22 diverse experts worked on developing this material, using a robust co-creation methodology.

More about the faces behind the project can be found here.

Plain language summaries (PLS) of peer-reviewed publications and conference presentations: practical ‘How-To’ Guide for multi-stakeholder co-creation

This How to Guide will help you in the creation and dissemination of PLS, encouraging co-creation with patients at every stage of development.

The guide has been co-created with a wide variety of stakeholders, including patient representatives, industry members, publishers, researchers, medical communication agencies and public officials involved in research bodies.

More about the faces behind the project can be found here.

Are you planning a patient engagement activity in the early discovery and preclinical phases of medicines development?

A specialised How-to Guide, co-created with experts, is here to support you.

Find out more Click here to find out more

How-To Guide for Patient Engagement in the Early Discovery and Preclinical phases

This guide takes you step-by-step through an innovative process of identifying key patient partners, gaining important insights that help improve early research from unmet needs, developing research methodology and fostering important and long term partnerships.

The guide has been co-created by 36 people from 16 organisations.

More about the faces behind the project can be found here.

Are you an expert in the development of a clinical outcome assessments (COA) strategy?

We need your help in finalising the first co-created, comprehensive Patient Engagement How-to Guide For COA Strategy Development

Public consultation open until July 2nd, 2021

Find out more Click here to find out more

How-to Guide on patient engagement in the development of a clinical outcome assessment (COA) strategy

This guide will help you include patient engagement in the development of a COA strategy within clinical trials, with a specific focus on Patient-Reported Outcomes. This guidance aims to provide a basis for more meaningful and systematic engagement of patient partners at each of the critical milestones in the COA strategy development.

More than 22 diverse experts worked on developing this material, using a robust co-creation methodology.

More about the faces behind the project can be found here.

Are you an expert in clinical trial protocol design?

We need your help in finalising the first co-created, comprehensive Patient Engagement How-to Guide For Clinical Trials Protocol Design

Public consultation open until July 2nd, 2021

Find out more Click here to find out more

How-to Guide on patient engagement in clinical trial protocol design

The guide provides you with all the information you may need for patient engagement in clinical trial protocol design, in one place. It provides 4 key steps for patient engagement in this activity, alongside clear explanations on how to advance at every step of the way, common taxonomy, additional resources and guidance.

More than 22 diverse experts worked on developing this material, using a robust co-creation methodology.

More about the faces behind the project can be found here.

Are you planning a peer-reviewed publication? Would you like patients to be able to access it and understand it?

Download now the first experts co-created How-To Guide for the development and dissemination of plain language summaries of peer-reviewed publications and conference presentations.

Find out more Click here to find out more

Plain language summaries (PLS) of peer-reviewed publications and conference presentations: practical ‘How-To’ Guide for multi-stakeholder co-creation

This How to Guide will help you in the creation and dissemination of PLS, encouraging co-creation with patients at every stage of development.

The guide has been co-created with a wide variety of stakeholders, including patient representatives, industry members, publishers, researchers, medical communication agencies and public officials involved in research bodies.

More about the faces behind the project can be found here.

Guidance for Community Advisory Boards

Are you planning to set up, run, or engage in a community advisory board? Then this guidance and related tools are for you. This guidance has been developed by the PARADIGM public-private partnership. PFMD is committed to its adoption, maintenance and sustainability.

Patient Engagement in Early Dialogues (HTA)

Are you working in an HTA body? Are you interested in patient engagement? Then access this highly adaptable set of tools to guide you through your patient engagement journey. This resource has been developed by the PARADIGM public-private partnership. PFMD is committed to its adoption, maintenance and sustainability.

Patient Engagement Resource Centre for Translational Researchers
An easy-to-navigate platform to help you get started with patient engagement in research. The selected relevant public resources will help you understand the basics of patient engagement, and guide you through the different phases of patient engagement: from planning to conducting and evaluating.

The resource centre is developed by Eatris, the European Patient’s Forum (EPF), and the European Aids Treatment Group (EATG).

Background

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2017

As part of PFMD’s co-creation mission to deliver tools and guidances for enhanced patient engagement, a list of most common 150+ patient engagement activities was identified

2018

More than 100 people from over 50 organisations worked on delivering a co-created guidance with criteria for good patient engagement (PEQG)

As part of the effort for creating a comprehensive guide for systematic patient engagement,the first edition of Book of Good Practices was released, following the PEQG criteria

But we couldn’t stop here. The patient engagement community was in need for more detailed How-To Guides for at least some of the identified activities (from the 150+ list)

A public consultation was organised to help narrow down the list and prioritise the most needed topics.

2019

Piloting of the generic guidance (PEQG) started and more and more organizations started to use it as the go-to initiation or evaluation tool for patient engagement.

Multi-stakeholder working groups started to take shape, aiming to develop co-created How-To Guides covering the previously prioritised activities. These would be specific activities from the medicines development phases, but also covering overarching topics (i.e. plain language summaries)

2020

The groups continued to grow (54%, from 67 to 103 by June 2020), benefitting from the enthusiastic involvement from experts and representatives from over 50 organisations.

Currently there are 4 How-To Guides at different stages of completion

Public consultation for some of the How-to Guides

2021

Public consultations

Launch of the How-to-Guides

These groups laid the foundation for effective patient engagement with the co-creation of the Patient Engagement Quality Guidance (known also as PEQG for short) and the Book for Good Practices (or BoGP) – both released in May 2018. These tools were devised from the contributors’ aggregated experience, reviewed and validated through public consultation, as well as expert reviews in specific focus groups. They offer a framework for engaging patients and provide concrete and real-life examples of patient engagement in action, and are an integral part of the Patient Engagement Management Suite.

The Patient Engagement Quality Guidance serves as a core building block for the Patient Engagement How-To Modules – step-by-step, in-depth guides on making patient engagement happen, developed through co-creation Working Groups active in 2019 and 2020. These How-to Guides are built following a 4-phase methodology already proven effective when developing the Patient Engagement Quality Guidance.

People and organisations that are actively working on developing these guides

You can see below a quick glimpse of the network behind these materials. Access Synapse to view more, as well as other associated resources

Perspectives from contributors

Training can help to build capacity for patient engagement

May 5th 2020 by Gary Finnegan

Training, including online education, can play a key role in developing mutual understanding between clinical researchers and the patients whose needs they aim to meet.

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Involving patients in drug development – from the start

May 12th 2020 by Gary Finnegan

Meaningful patient input in drug development is still in its infancy. Medicines regulators, including the FDA and EMA, began systematically engaging patients less than a decade ago. 

+ Read more

Implementing patient engagement in clinical trial design

May 19th 2020 by Danielle Barron

Even in the best of circumstances, clinical research is a complex and challenging endeavour. In recent years, however, the pharmaceutical industry has realised that the unique insight only a patient can provide is crucial to successful trial design.

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Researchers and patients benefit from co-designing clinical trials

May 27th 2020 by Gary Finnegan

Clinical research can be time-consuming and costly for scientists and sponsors, and maybe a burden on those participating. One way to make patient recruitment easier, and to reduce the number of people who drop out of trials before their conclusion, is to involve patients in designing studies.

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Patient information leaflets: “Putting patients’ needs first is vitally important”

June 9th 2020 by Danielle Barron

Patient engagement in the drug development process does not come to a screeching halt when the medicine eventually reaches the market.

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The final piece of the puzzle: capacity building in patient engagement

June 24th 2020 by Danielle Barron

The PFMD How-To Module for Capacity Building is a repository of training, education and capacity-building materials on patient engagement and pharmaceutical product development.

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All the PEM Suite tools are designed to work together.

Interested to learn more about patient engagement?

Starting a patient engagement initiative and need support with legal and contractual work?

The “Patient Engagement Management Suite” is brought to you by the PFMD partnership.