Making trials more accessible through better patient information leaflets
To find better health treatments for people, we need to carry out research. One type of health research is a ‘clinical trial’, where we find out which treatment is best. Before people agree to take part in a clinical trial, they need to be given information, so that they can decide if they want to take part. This information is usually given as a patient information leaflet or ‘PIL’.
Accessible PILs
PILs used in clinical trials are often long, complicated and not written plainly enough. The aim of the MAPLE project is to make sure that people feel that they have the information they need to make a choice, in a way that is clear and easy to understand, or ‘accessible’. It also aims to make sure that everybody feels that they are welcome and included, if they want to take part.
The information on this website is to help researchers to create accessible PILs for clinical trials for adults. This will be as part of a ‘layered’ approach, which means that researchers will give different information in stages. The accessible PIL aims to provide patients with the information they want to know to help them decide whether they are interested, before finding out more about a clinical trial.
This accessible PIL does not replace the need to give more information, for example about what researchers will do with people’s data under the General Data Protection Regulation (GDPR) rules. It is not supposed to be the only source of information, but a clear introduction and part of a layered approach to help people decide if they want to know more.
Who we worked with
The accessible PIL and guidance on this website was created from work we did first about making information more accessible. This is published here: CLICK FOR INFORMATION
We also worked together with a wide range of people. This included:
- People from minoritised ethnic backgrounds, where many of the people speak, read or write languages other than English
- People with learning disabilities and/or autism
- People in patient advice groups
- People from different patient charities
- Health researchers
You can find more information about the MAPLE project in the ‘About Maple‘ section of the website. More information about team and the community groups, patients and charities we worked with is in the ‘About us‘ section of this website.
What we have made
An accessible PIL which can be downloaded by researchers and edited for their clinical trials
The accessible PIL has been filled with an example of a trial to show people how to fill it in. There are sections that need to stay the same and sections that will need to be edited for each different trial. Researchers will need to use the guidance information to edit the accessible PIL.
Information on how to use and to edit the accessible PIL
We have carried out a lot of work with a wide range of people to make the accessible PIL and guidance. We recommend that researchers also work together with a range of people on the trial-specific sections and the images they use for their PIL. This is to make sure that the PIL they make is clear, accessible and represents everybody.
An image bank
We have given examples of images that can be used for each section of the accessible PIL. These are provided as part of the collection of guidance documents. If researchers want to use any of these images, they will need to follow the link to the website that owns them to legally buy them.
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Funding Acknowledgement
This work was funded through the ICS Research Engagement Network (REN) development programme. This study is also supported by the National Institute for Health and Care Research Bristol Biomedical Research Centre. The views expressed in this publication are those of the authors and not necessarily those of NHS England or the Department of Health and Social Care.