Making patient engagement happen across the medicines lifecycle

The How-To Guides are in-depth practical guides for
specific patient engagement activities and a key tool
from the Patient Engagement Management Suite.

They are built to complement the Patient Engagement Quality Guidance, through a systematic co-creation methodology,
involving over 83 experts from 50 organisations.

What are the How-To Guides

How-To Guide for the Early Discovery and Preclinical phases

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How-To Guide for the Clinical outcome assessment development

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How-To Guide for Protocol Design

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How-To Guide for the Regulatory phase

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How-to Guide for the post-launch phase

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How-To Guide for Plain Language Summaries in peer-reviewed publications

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How-To Guide for Capacity Building

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How are these guides developed

Although each How-To Guide has its own specificity, their development follows a similar methodology:

Content definition & preliminary models

How-To Guide structure tested & agreed

4 review and
validation rounds

Public consultation

Feedback implementation & make it available to the public

Piloting phase
expected to start end of
2020

Background

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 7 How-To Guides at different stages of completion

Public consultation for some of the How-to Guides

Launch of the first 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

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