Workshop on ‘Barriers and Solutions to Participation in Clinical Trials’ at the Cancer Trials Centre Patient Engagement Day on 23 June 2023

Authors: Gillian Isherwood¹, Eddie Carr¹ and Linda von Neree²

The workshop ‘Barriers and Solutions to Participation in Clinical Trials’ was part of the Cancer Trials Centre Patient Engagement Day on 23 June 2023. The UCL Translational Research Office supports many clinical trials which are run at the Cancer Trials Centre. Workshop attendees, including a mixed group of patients, carers, members of the public, clinicians, clinical trial and data managers and researchers, identified barriers to participation in clinical trials and searched for possible solutions.

After introductions and an icebreaker activity, attendees brainstormed potential barriers to participation in clinical trials based on their own views and experiences. Workshop facilitators wanted to explore if there are different perspectives of patients, carers and members of the public (pink sticky notes) attending and health care professionals, trial managers and researchers (yellow sticky notes). This helped to choose barriers from each group to come up with possible solutions in the second part of the workshop.

‘I really enjoyed it (the workshop) and listening to others gives lots of ideas. I think there is lots of information to work with from our workshop.’ – Gillian Isherwood, Cancer Trials Centre Patient Representative and workshop facilitator.

Identifying barriers

Workshop attendees identified the following barriers to participation in cancer clinical trials:

1.      Barriers identified by patients, carers and members of the public

• What is research? (No knowledge), and what are the benefits?
• Fear and trust
  • Not wanting to be a guinea pig vs. ‘Trials’ change the world
  • NHS trust issues
• Knowing which trials are available to me
  • Knowing who to ask and having the confidence to enquire about trials – everyone is so busy, especially oncologists and their clinical support staff
  • Patients access to information
• Not asked to participate
  • Perceived (?) lack of fitness/capacity to consent
  • Assuming a patient is too upset to consider a trial
• Messengers – Who are ‘The best messengers’ about study participation?
• Language barriers and lack of understanding
  • Understanding the technical/ clinical language used to explain the trial and dealing with feelings of frustration stemming from this
  • Need for clearer communications, less medical terminology
  • Not enough or too much information
• Difficulty to understand and clearer explanation of ‘randomisation’ required, and unwillingness to be randomised
• Location/type of hospital
  • Medical teams having info/ access to options
  • Lack of awareness (by clinicians)
  • Financial and/or travel barriers incl. expenses not reimbursed
• Routine treatment and timing
  • Treatment burden incompatible with other commitments
  • Given a treatment date before trial info e.g., Surgery – leaving no time for a window trial
  • Not being given sufficient time to consider taking part
  • Time consuming?

2. Barriers identified by health care professionals, trial managers and researchers

• Lack of trust in research
• Lack of understanding of clinical trials and clinical research (patients may not see a point in participating and the impact it has)
• Cultural barriers
• Access and distance barriers
  • Access to a hospital running/involved in a trial
  • Location of nearest site that provides a relevant trial is too far
  • Access to available clinical trials not being run at your hospital
• Extra visits and procedures for the trial (time, money, inconvenience)
  • Additional time spend in hospital/additional waiting time
  • Amount of procedures e.g., number of blood biopsies
  • If there are invasive procedures e.g., mandatory biopsies
  • Travel – costs of travel and distance of travel
• Information about clinical trials
  • Can we be sure the patient does fully/really understand risk/benefit of a trial (objective measurement)?
  • The patient information sheet – too complex but mandated to include information
  • Confusing information
  • Contradicting information from different sources such as social media (different reports from different sources)
• Networking – lack of networking between researchers and patients, clinicians and patient and public members involved in research
• NHS capacity and difficulty in running a trial i.e., pressure from funders/ tasks sponsor has to do

Patients, carers and members of the public and health care professionals, trial managers and researchers identified many similar barriers including cultural barriers and understanding of clinical trials. For patients, carers and members of the lack of trust, clear information and easy access were barriers to take part in trials. Health care professionals, trial managers and researchers listed NHS capacity, the difficulty of running trials, additional study visits and/or procedures and the lack of networking between researchers and patients, clinicians and patient and public members involved in research as barriers for participation.

‘Health Research is best served and improved when many voices are heard and a greater diversity of voices is an important factor in the pursuit of addressing & reducing known health inequalities.’ – Eddie Carr, Cancer Trials Centre Patient Representative and workshop facilitator.

Finding solutions

In the second part of the workshop patients, carers, members of the public, health care professionals, trial managers and researchers worked together in two groups to talk about a specific barrier to participation in trials and to discuss of possible solutions. Workshop facilitators choose a topic for each group. One group looked at ‘Language and cultural barriers’ identified from patients, carers, members of the public.

Solutions to overcome language barriers

• For foreign languages, multi-national sites could use the patient information sheet from different countries
• As a relative cannot be an interpreter, it may be expensive and takes time to get consent, the group questioned if it may not be plausible for every language? But agreed that it is often possible to get translation. Language barriers should not be a valid reason to hinder trial participation in the same way that it does not hinder access to routine NHS treatment/s.

Other solution to overcome language barriers, not relating to foreign languages, could be:

1. Induction for every cancer patient to explain new language and explain process
2. Pre-recorded explanations
3. 1:1 session initially
4. Glossary online which is accurate and in patient information sheets to explain terms for histology reports, trial terms and abbreviations

Solutions to address culture barriers

1. Have patient and public members involved in research as people who are connected to communities that need more representation are able to assist and can create networks
2. Support centralised networks such as charities connected to patient and public members involved in research and different centres/hospitals
3. Create online access to trials
   • Have global access to trials
   • Enable universal access to trials around you
   • Encourage use of proactively looking for trials online and condition specific charities
   • Signpost patients to look at these sites when diagnosed
4. Create workshops and videos about trials and participation
5. Make use of support groups to discuss access and participation in clinical trials

A second group discussed the ‘Amount of procedures e.g., number of blood biopsies in a trial’ as a barrier to participate in clinical trials from the perspective of health care professionals, trial managers and researchers

Solutions to overcome the amount of procedures

1. Make sure patients are aware of extra tests and visits up front and it is planned from start
2. Provide patients with a schedule/study diary for procedures and study visits
3. In the Patient Information Sheet, outline schedule week by week/a calendar/chart
4. Explain the reason for the extra procedures and/or samples
5. Try to align trials visits/assessments with standard of care as much as possible when designing a trial and combine extra blood tests with standard of care blood tests, so that blood is only taken once
6. Transparency about procedures in Patient Information Sheet (PIS) and use visuals in the PIS and/or videos to explain procedures
7. Individual approach for each individual patient and address each person’s concerns
8. Translational samples/optional research/sub-studies need better explanation
9. For biopsies: Reassurance about offering pain relief
10. If a patient is anxious about procedure or there are difficulties (e.g. to take blood for blood tests) the most experienced practitioner should perform it

Both groups captured possible solutions on large sticky notes. Group chairs presented the barrier and solutions discussed at first to the other workshop group and later to all attendees at the Patient Engagement Day.

Summary

This workshop and the Engagement Day showed the power of diverse stakeholders – patients, carers, members of the public, health care professionals, trial managers and researchers from different backgrounds – working together to tackle challenges and come up with solutions. We encourage you to explore barriers in research and possible solutions to barriers, including those identified in this workshop, in partnership with diverse stakeholders including healthcare professionals, patients, carers and members of the public.

Getting involved in Patient and Public Involvement (PPI) has changed the way I view Health Research and its ongoing quest to develop better treatments for the benefit of all. The dedication and passion of the researchers and healthcare professionals involved in this important work has to be seen to be believed. PPI enables you to not only see research unfold, your thoughts and opinions are welcomed and your voice and /or that of your community can be heard at the heart of research. For me It’s not a question of “Why Get Involved“ but rather, “Why Not”, when You can make that difference! – Eddie Carr, Cancer Trials Centre Patient Representative and workshop facilitator

This summary is shared with all event attendees, involved patient groups, charities, staff at the CRUK CTC Cancer Trials Centre and wider stakeholders and funders to make use of suggested solutions. We will encourage you to create opportunities to discuss possible solutions to barriers identified, which have not been tackled during this workshop.

Workshop development and facilitation

• Gillian Isherwood¹
• Edwin Carr¹
• Linda von Neree²

‘We felt that despite planning this workshop online, it worked well and it was an excellent opportunity to work together. We enjoyed hearing attendees’ feedback, and we will share learnings.’ – Gill, Eddie and Linda, workshop facilitators.

Authors details

¹ Patient Representative, CRUK & UCL Cancer Trials Centre
² Patient and Public Involvement Associate, CRUK & UCL Cancer Trials Centre

Contact for questions
Linda von Neree via email to l.vonneree@ucl.ac.uk