Find out everything you need to know about how you can support and shape clinical trials in ways other than taking part. This section will give you an overview of:
Patient and Public Involvement (PPI) is a term coined by the research and pharmaceutical industry to describe the collaboration of those developing new treatments or medicines with those expected to benefit from using them. Although many people with health conditions prefer not to be called patients, this is the term used by the National Institute of Health Research in their definition of Involvement in research:
"Research carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them" (NIHR INVOLVE www.invo.org.uk)
At the Trust, we prefer to refer to PPI as community involvement. This should be an active, collaborative and a highly valuable opportunity for the people who run clinical trials and the CF community, ensuring the community are involved as advisors and partners.
Involvement in trials is different from participation in trials. Involvement does not mean taking part in a specific trial. Involvement is sharing your knowledge and experience of living with CF and how the condition impacts on your daily life. Your knowledge and understanding can influence and shape clinical trials being developed.
Taking part in an Involvement activity can involve a number of activities. These could include:
- Being part of a discussion about a study proposal.
- Reviewing the plan for a trial and feeding back on whether you think the appointment schedule is manageable.
- Thinking about how data collection might impact you or your child (eg whether taking part in additional lung function tests would be too much of a burden).
- Reviewing a study questionnaire to make sure the questions are asked in an appropriate manner.
- Helping to design the invitation to be given to prospective trial participants in order to make it engaging and easy to read.
Involving people with CF is one of the major elements driving the Trust’s Clinical Trials Accelerator Platform. Our mission is to advance CF care through clinical trials and unite people living with CF with researchers and industry to achieve a life unlimited by cystic fibrosis.
The Trials Accelerator Involvement Team is made up of people either living with CF themselves or parents of someone with the condition. We actively seek opportunities for the CF community to take part in involvement activities at every possible opportunity, promoting the benefits this brings to Sponsors, including improved recruitment and retention rates for participation which leads to faster completion of trials and collection of results. This in turn benefits people with CF, giving them more opportunity to take part in trials and faster access to new medicines.
It’s important that people with CF can show researchers how to adapt their trials to meet the needs of a community who already have a heavy burden of care. This will ensure that clinical trials meet the requirements of the CF community, not just the interests of researchers or pharmaceutical companies.
As the benefits of involving the CF community in research and clinical trials become more apparent, we are receiving an increasing number of requests from sponsors. We would like to share these opportunities with as many of you as possible.
Our CF Trial Ambassador’s Forum is made up of representatives from the whole CF community. Individuals of a variety of ages, backgrounds and experiences share their views and opinions by answering surveys and questionnaires, or by joining online focus group discussions, allowing them to interact with research teams and other people with cystic fibrosis. As a CF Trial Ambassador you will be able to share your experiences of living with CF or of trial participation with researchers, and researchers will be able to share information about the work they are doing with you, allowing for an equal exchange of knowledge.
If you want to become a CF Trial Ambassador, find out more and register your details here.
We have an established group of Lay Reviewers (people with CF or their parents, who have no scientific training or experience) who liaise with researchers to ensure the community’s needs and existing heavy treatment regime of CF are taken into account when clinical trials are being designed. Having completed our online e-learning module for tips on lay reviewing, they have the opportunity to shape and influence the design of trials by reviewing the trial plans and procedures in advance, as well as reviewing the results published upon completion of a trial. If you would like to join a waiting list to become a Lay Reviewer, please mention this on the CF Trial Ambassador’s registration form.