'25 at 25': Patient and Public Involvement (PPI)

29 May 2024

For almost two decades, the MRC Clinical Trials Unit at UCL has been committed to actively involving patients and the public in all our clinical trials and studies. As part of our ‘25 at 25’ series to celebrate the Unit’s 25^th anniversary, this piece explores some of our big achievements in relation to Patient and Public Involvement (PPI).

When describing PPI we use the NIHR-INVOLVE definition:

“Patient and Public Involvement in research is described as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. It is an active partnership between patients, the public, and researchers in the research process.”

Our PPI work is overseen by the PPI Group. This was originally set up as a cancer group in 2006. Later, in 2008, there was a bigger drive to unify PPI across the Unit and therefore the group expanded to include those working in infections and HIV trials. Today, the PPI Group is made up of staff and seven PPI representatives with a wide range of experience in different areas.

Before most Clinical Trials Units were even considering it, the MRC CTU at UCL had clearly stated a commitment to PPI and established an across-Unit PPI group. Since its establishment, our PPI Group have undertaken research to help improve PPI within the Unit and beyond, as well as developing a collection of PPI resources for patients, carers, members of the public, and researchers.

In 2009, a baseline survey was developed with the aim of evaluating the extent of involvement throughout the CTU, and also establishing the perceived impact of this involvement on the research from the researchers’ perspective. This led to a publication in Trials and the launch of a policy on PPI in 2012. The development of the PPI standard operating procedure (SOP) means it is mandatory for all trials to have PPI. The SOP has been a game changer, helping to ensure this happens in practice.

The Unit’s PPI strategy was co-produced with the PPI representatives on the PPI Group. The strategy is accompanied by an annual implementation plan to ensure we deliver our PPI objectives. Last year the plan included 18 specific activities and all of them involved at least one PPI representative. In fact, three activities were led by a PPI representative.

Some examples of the Unit’s PPI activities include the first ever template for patient information sheets co-designed by patient representatives. This is currently being revised in a project led by one of the Unit’s PPI representatives, Ben Cromarty.

The induction pack for new PPI representatives joining trials was also co-produced with our PPI Group. The pack provides background information about the trial they will be working on and outlines what is expected from their role and what support is available.

Our PPI representatives have co-designed and co-delivered plain English training for researchers, as well as a training session on PPI in trials, which has been run online and face-to-face. They also teach alongside MRC CTU staff on PPI modules as part of UCL’s MSc in Clinical Trials and BSc Medical Sciences, helping the next generation of researchers and medical professionals appreciate the importance of PPI.

The Unit has a responsibility to share its learning and so we have produced publications over the years that were co-authored with our PPI representatives. The PPI Group are building a ‘library of good practice’, which includes all the impressive examples of PPI in the Unit, with the aim of eventually publishing them. Patient co-developed PPI training materials are also freely available on the Unit’s website, as well as trial-specific videos, such as STAMPEDE results videos which feature trial participants and others affected by prostate cancer.

Across all our trials, PPI representatives work hard to make participant- and patient-facing materials more accessible in plain language. We also work with Penta’s Youth Trials Boards (YTBs), whose innovative work includes infographics and animations to complement the patient information sheets.

More recently, we collaborated with Penta and the Health Research Authority to produce a new animation to help children and young people understand GDPR when they are being asked to take part in a trial. The video is designed to be shown to participants before they sign a GDPR form, allowing them to give informed consent to take part in medical research. Young people from the CHIVA Youth Committee and Penta YTBs in Uganda, Zimbabwe, South Africa and the UK helped create the story and script, ensuring the content was appropriate for the intended audience.

One of the Unit’s main achievements is that PPI has grown from being something very patchy, which some staff did in some trials, to now having active, meaningful PPI in all trials.

Therefore, there has been a huge cultural shift within the Unit. Along this journey, the MRC CTU at UCL has worked with some brilliant PPI representatives and consultants, we have and learnt so much from all those people. We endeavour to constantly try to improve the value of our PPI and the experience of those delivering it.

Further information: