Can you tell us the role of the IBD Team at the BioResource?
The inflammatory bowel disease (IBD) BioResource was launched in 2016 to help improve the lives of people affected by Crohn’s and colitis. It is a nationwide research platform which aims to drive and facilitate studies in IBD and help develop new treatments for Crohn’s and colitis.
This platform is part of the NIHR BioResource, and holds DNA, serum, clinical and genetic data from people with Crohn’s or colitis recruited from participating hospitals across the UK. All volunteers donate a blood sample and complete a questionnaire.
They also consent to be contacted to take part in future medical research, based on analysis of their samples and information they have supplied. The DNA samples are used to help identify genetic risk factors for Crohn’s and colitis, as well as understanding how genetic make-up affects progression of the disease and treatment response.
The data held and the participants who make up the IBD BioResource can be accessed for research purposes by any investigator who submits an application which receives approval. The goal is to support research studies which will lead to find better treatments, and ultimately a cure for Crohn’s and colitis.
The IBD BioResource team coordinates the recruitment of patients, including the collection and receipt of samples and data. The team also provides support to all open and recruiting sites, as well as support for potential volunteers enquiring about joining the IBD BioResource.
To further drive the IBD BioResource in supporting important IBD research, the IBD team also makes the work of IBD BioResource known to industry, academia, Crohn’s & colitis patients and the public at every given opportunity.
Can you tell us a bit about the importance of the IBD team in the BioResource’s work?
IBD, comprising Crohn’s disease (CD) and ulcerative colitis (UC), affects ~500,000 people in the UK. It causes relapsing intestinal inflammation, with 25% of patients presenting before the age of 18 years. Accelerating research into the causes of CD and UC across all ages is essential for clinical translation but requires access to large and well-characterised cohorts of patients based on their known genetic make-up and detailed disease characteristics.
The work of the IBD team in opening new sites to the IBD BioResource and in driving recruitment at current participating hospitals has helped to build this very much needed IBD BioResource panel. Data and samples accrued can be accessed by any investigator (see Using the BioResource for further details) and provide invaluable tools for IBD research striving to:
- find new treatments for Crohn’s and colitis
- understand why some people have more severe Crohn’s or colitis
- understand why some treatments work for some people but not others
- predict disease progression and complications.
The IBD team has recruited > 43,000 people with Crohn’s and colitis across 100+ participating sites to date and is aiming to reach a new target of 50,000. This is the largest group of people with Crohn’s and colitis involved in research in the UK.
What does a regular day look like for the IBD team? What other teams do you collaborate with at the BioResource?
The work of the IBD team is multi-faceted and requires close working relationships with other teams of the NIHR BioResource. Our main tasks and responsibilities are centred around the following:
Site management: The IBD team is always available to answer any queries our participating sites may have regarding the recruitment of patients and the collection of clinical data via clinical report forms. We also ensure that new members of staff are provided with timely training and we deliver regular refresher site induction sessions. Together with the common diseases team, we also make sure stock requests are processed in a timely manner and that all sites have sufficient resources and materials to recruit patients.
Panel management: One very important aspect of our work is also to check that consent forms (CFs) from patients taking part in the IBD BioResource are valid, have been completed correctly and are signed. With recruitment regaining momentum in a post-pandemic era, it is not unusual for our team to receive and process between 250 and 300 CFs per week!
Data and sample management: Together with the NIHR BioResource IT & Data Scientist teams, we ensure timely, secure and correct collation of data for various BioResource databases (REDCap and ORCA). We also have a close working relationship with the Samples team to ensure samples received at the National Biosample Centre are accurately labelled and that corrective actions are taken should there be any issues.
Engagement with volunteers: Potential volunteers may become aware of the IBD BioResource through means other than visiting their local hospital and contact us directly. In these instances, we provide them with the necessary information, answer any questions they may have and, if agreeable, ask the relevant participating hospital to get in touch with them.
Engagement with industry and academics: Our work directly feeds into the Stage 2 team and the Data team, who coordinate the recall of participants to take part in research or the access to phenotypic and/or genetic data, respectively. Together, we often look into the feasibility of potential recall studies and the availability of volunteers' data for a wide range of prospective studies.
What’s the most rewarding thing about working in your team?
The most rewarding aspect of being part of the IBD team is knowing that the work we do today will contribute to making a difference to patients living with Crohn’s and colitis, tomorrow. It is really uplifting to see how patients are eager to take part in research and share their journey with us.
What three words would you use to describe the IBD team?
Owing to the very infectious enthusiasm of our Chief Investigator, our team is Friendly, Enthusiastic and definitely Busy!
What key areas and projects are you working on at the moment?
Genetic feedback of incidental findings
Patients joining the IBD BioResource are given the option of being told whether they are at an increased risk of specific rare treatable genetic diseases (the same as those reported by Genomics England, an NHS partner). All these are rare, but some are associated with a potential increased risk of developing serious diseases including cancer.
Many patient samples from the IBD BioResource have now undergone genome sequencing and are being analysed. To implement a robust genetic feedback process, we have sought advice from various stakeholders and professionals in the field of clinical genetics and are in the process of running pilot studies to test out some aspects of this process.
The first step will be to remind participants what they signed up for and the choices they originally made with regards to receiving genetic feedback, and to allow them to change their mind if needed. To drive this forward we now have in place ethically approved documents that will seek genetic feedback consent confirmation and other stepping stones along the proposed candidate journey. We aim to test our genetic feedback process in pilot centres early in 2024 and gradually roll out the process in a group of sites.
IBD Dialogue Event
To help shape how we can give feedback in a way which is helpful and does not cause anxiety to patients, we also want to work with people who have Crohn’s or colitis and are participating in the BioResource to understand their expectations about the results they might receive from analysis of their DNA.
We are therefore co-organising an IBD Dialogue Event, commissioned together by the Wellcome Sanger Institute Human Genetics programme and the Wellcome Connecting Science Research & Dialogue team, and facilitated by Hopkins Van Mil. This event will take place in person on Monday 20 November at the Wellcome Genome Campus in Cambridge.
The workshop will involve a series of group discussions between researchers and participants. In addition to discussing the work of the IBD BioResource, it will be an opportunity to hear from other projects about how feedback is provided and what clinical follow-up occurs.
What is the most challenging part of your role?
Like many of our colleagues who oversee and manage large cohorts of volunteers in the NIHR BioResource, the IBD team’s biggest challenge is to keep abreast of all our recruiting sites and ensure recruitment of patients is meeting the quality and standards required. This requires a very high level of organisation and attention to detail.
What exciting projects are on the horizon surrounding the IBD team?
IBD BioResource data refresh
The IBD BioResource is about to embark on a project aiming to update some clinical data.
Over 33,000 IBD BioResource patients were recruited pre-pandemic in 2017-2019. At that point, a new line of biologics (Ustekinumab and Tofacitinib) had only recently been licensed. Furthermore, although >14,000 patients were prescribed TNF inhibitors, the peak in its use in the UK only came in 2016-18. Consequently, current baseline CRFs only provide a modest length of follow-up data, therefore limiting the interpretation of long-term outcomes at scale.
To help with this, we are looking to undertake a data refresh for all participants recruited pre-pandemic. In particular, we are looking into the treatment response data across IBD BioResource participants as many will have been started on new treatments since they were enrolled on IBD BioResource, including those targeting mechanisms other than TNF. We are also updating core IBD phenotypes, looking at disease progression and complications in Crohn’s and the need for surgery in UC.
This data will be included in new, highly powered analyses seeking pharmacogenetic associations with treatment response and seeking to further understand non-response, loss of response and disease complications. We have undertaken a pilot study to road-test the 'advanced therapy' and 'phenotype update' forms and are about to launch this more widely across our sites. We hope to complete this exercise early next year, pending the delivery of external funding.
A huge thank you to Laetitia Pele and the team for this valuable insight into the workings of the Inflammatory Bowel Disease (IBD) Team!
Anyone can join the general population BioResource, whether you have a health condition or not. Find out more about how to take part!
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