B8 - How to write great lay summaries and empower patients


Organised by the FIP Health and Medicines Information Section in collaboration with the FIP Industrial Pharmacy Section


DK Theo Raynor (University of Leeds, UK) and Sini Eskola (Regulatory Affairs EFPIA, Belgium)


Lay summaries of regulatory documents are playing an increasing role in empowering and engaging patients. One of the first types of lay summary, public assessment reports, produced by the European Medicines Agency, is well established. Companies will soon have to produce lay summaries for Clinical Trial Results — this in addition to the Risk Management Plan Summaries which pharmaceutical companies now have to produce. This means that staff working for pharmaceutical companies, notably pharmacists, have an interest, as they have to write these summaries — without necessarily having the skills to write effectively for lay people. Equally important stakeholders are practising pharmacists (including those working in medicines information), who could be the ideal intermediaries to help patients get the most out of these summaries. Patients are the target for these summaries, and so they themselves have an important role, and a patient representative will be one of the faculty for the session.

Research into these summaries suggests that we are not providing lay people with the information they want, in the form that they want. There is now draft guidance — in this session key stakeholders will discuss putting this guidance into practice.


09:00 – 09:10

Introduction by the chairs

09:10 – 09:25

1. Overview of the trends towards lay summaries

Sini Eskola (Regulatory Affairs EFPIA, Belgium)

09:25 – 09:50

2. General principles for developing lay summaries — What the research tells us

DK Theo Raynor (University of Leeds, UK)

09:50 – 10:20

  1. What user testing has shown about how best to develop clinical trial results summaries

Angelika Joos (MSD, Belgium)

10:20 – 10:40 (Coffee/tea break)

10:40 – 11:05

  1. What do patients want from lay summaries?

Nick Hartshorne-Evans (Pumping Marvellous, UK)

11:05 – 11:50

  1. Workshop — Evaluating a clinical trial results lay summary

Led by DK Theo Raynor and Nick Hartshorne-Evans

11:50 – 12:00

Conclusions by the chairs

Learning Objectives

At the end of this session, participants will be able to:

  1. Describe the nature of lay summaries and their role in policy and practice;
  2. State the key principles to apply to the writing of the summaries;
  3. Identify the role of the pharmacist in maximising the benefits of the summaries to patients;
  4. Explain a lay summary for patient-centeredness.

Type of session: Knowledge-based