There are two primary forms of IBD – ulcerative colitis and Crohn’s disease – both of which have a marked impact on a person’s daily life. As with the majority of health conditions, symptoms and severity vary from patient to patient; however, common experiences include persistent diarrhoea, abdominal pain, weight loss, and fatigue.
IBD conditions are often episodic in nature. Symptoms can go into remission for days, months, or even years before a flare-up occurs. For researchers, this complicates matters, as monitoring and treating a fluctuating condition over time requires a great deal of information about both the nature of IBD, and the external environmental factors that exacerbate symptoms.
While there is still no cure for IBD, multiple treatments have been approved to help patients achieve and maintain remission. This gives the lining of the gastrointestinal tract a chance to heal, something that can substantially improve quality of life for the patient. The challenge is, when patients exit the clinical setting, the appearance and severity of their symptoms don’t stay static. One bite of the wrong food at the wrong moment can throw a spanner in the works.
This is a big problem for treatment, as practitioners can only make therapeutic decisions based on the information they are given. As such, it is vital that organisations fill the gaps in IBD knowledge to accelerate IBD research and drug development. Verily, Alphabet’s life sciences research arm, is one such company working to develop a more holistic understanding of IBD, with help from those who know their conditions best – patients.
To find out more, Deep Dive caught up with Amy Abernethy, chief medical officer at Verily, to discuss the need for longitudinal, holistic data in IBD research, and the importance of giving patients a seat at the table.
As Abernethy explains, the pilot followed participants with IBD over time, collecting data such as patient-reported outcomes. Now, having ‘stress-tested’ the viability of working in collaboration with the Foundation, the partnership is looking to expand upon their previous work and establish an infrastructure to rapidly answer clinical research questions in IBD, accelerate treatment development, and ultimately improve quality of life for people living with these diseases.
“The pilot data was like the toe in the water,” says Abernethy. “We were pressure testing a few different things. Are these the right data elements to be collected? Which patient reported outcomes are a low burden for people, but also provide meaningful information? What’s the right educational activity for people?
To create a more holistic representation of IBD, Abernethy explains that registry aims to gather patient data at different stages of their disease progression, providing a more comprehensive and contextual understanding of the information collected in clinical settings.
By compiling a detailed longitudinal record of patients’ health experiences, it will be possible to investigate significant clinical research questions. Moreover, the inclusion of features such as symptom and quality-of-life tracking will be particularly valuable in understanding the efficacy and benefits of treatments for chronic conditions like Crohn’s disease and ulcerative colitis. The registry data will be accessible to academic and industry researchers who can collaborate on the design of prospective studies or use the data for observational studies, and this information will be available through Verily’s clinical research suite and IBD Plexus, the Foundation’s current data platform.
Abernethy notes, “One plan is for longitudinal data collection inclusive of patient-reported outcomes, longitudinal clinical data, and then also the ability to build into progressively more complex data sets the data types, such as environmental exposure data, and information about the explicit treatments and care a person with IBD receives and how that happens across time.”
“But then, there’ll be intermittent interactions with the person to ask questions, such as symptoms, like belly pain and other concerns, quality of life, as well as the impact on daily things that matter, like being able to go to work or care for your children. So, really trying to understand both personal experience as well as life impact and then following those things over time.”
“IBD is inherently longitudinal, chronic, and burdensome in a person’s life,” explains Abernethy. “And so, being able to collect data directly from people living their real lives is very much in line with the kinds of solutions that Verily is building.”
This is not simply a passive experience for participants, she continues. Through the registry, patients have an avenue to directly contribute to research simply by sharing information about their health.
“We have a core belief that supporting patient advocacy and supporting patient communities is one way of supporting health and patient-centric precision health, because it’s not only a trusted community, but also patient communities know what people need,” explains Abernethy. “You’ve got the ability to aggregate an understanding of here’s what matters most, which may not be obvious. And so, that’s one of the things that we’re really excited about, the Crohn’s and Colitis Foundation relationship, because we think that they know the IBD community. We don’t want to presuppose that we understand it better.”
She continues, “There will be times when we’ll have to cross-check and say, you know, ‘Amy, it says that you went to the hospital last week. Is that true? It seems like you were there for three days. Is that accurate?’ Because the individual is the best person to cross-check information.”
Combining the genetic and lifestyle information provided by the patient with data from other sources, such as health records, creates a greater pool of information for researchers to draw from. As Abernethy highlights, there are still many unknowns when it comes to IBD, its causes, and the best way to treat and prevent flare-ups, but with the aid of longitudinal, real-world data, researchers can begin to identify patterns and relationships that were previously unexplored. This information can be used to develop personalised interventions that target the specific factors contributing to an individual’s gut health issues.
“You can also take a cut of the data and do an exploration of environmental exposure risks and outcomes in IBD so that you can, with patients’ or people’s permission, also recontact people for new clinical trials that might be appropriate for them because they’ve got inflammatory bowel disease,” says Abernethy. “There are blunt instruments and blunt scales right now, but they are not very precise, and it makes it hard to do clinical trials and drug development in this space, despite how badly it’s needed. So, you know, all of these things argue for patient-centric models with longitudinal data where multimodal data types are actually going to make a lot of difference, and where the patient advocacy space can really help move things forward.”
Eloise McLennan is the editor for pharmaphorum’s Deep Dive magazine. She has been a journalist and editor in the healthcare field for more than five years and has worked at several leading publications in the UK. Additional reporting contributed by Jonah Comstock.