Highlights from ECCO 2026
This year’s European Crohn’s and Colitis Organisation (ECCO) meeting (held 19–21 February in Stockholm, Sweden) focused strongly on holistic IBD care. PSI’s Kasia Moscicka, Head of Feasibility and Site ID, Julia Smolina, Head of Project Supervision and Immunology, Veronika Fekete, Director of Feasibility, and Agata Mikolajczyk, Senior Clinical Trial Specialist, were there. Read on for our important takeaways – including how holistic care in IBD extends beyond treatment philosophy and directly shapes how studies are designed, powered, planned, and executed – and what they mean for our sponsors.
You may be thinking, “Why are we still talking about holistic care?” At this year’s ECCO meeting in Stockholm, over 7,000 attendees gathered to explore what the term now truly means: not simply “patient-friendly”, but a mature view of disease management that moves beyond inflammation control toward long-term functional outcomes, damage reduction, improved quality of life, and coordinated, multidisciplinary care. Here are our takeaways from the meeting, focusing on holistic care as patient-centric, strategically planned, and treatment-oriented, and on how IBD trials will be impacted.
Strategic Crohn’s disease and ulcerative colitis trial design
Holistic care and strategic trial design are intrinsically linked: both aim to reflect the full reality of living with IBD. Trials must be designed to enable and measure outcomes beyond inflammation.
Bayesian designs for early-phase trials
Termination of phase 2 and 3 IBD trials is increasing year-on-year. ECCO highlighted that better trial designs are still needed to enable earlier signals of efficacy and safety, as well as tackle enrollment challenges.
Bayesian trial design incorporates prior knowledge to inform the probability of trial success, allowing evidence to accumulate and adapt as data is generated. By shifting from binary hypothesis-driven approaches toward testing probability, taking prior knowledge into account, Bayesian approaches can:
- Reduce sample sizes required to evaluate endpoints (and reduce placebo rates)
- Improve early-phase efficiency
- Provide probability-based interpretation of results.
The FDA has provided draft guidance this year recommending the use of Bayesian design where appropriate [1]. Use of adaptive trial designs is increasing in IBD [2, 3], but attendees stressed that we could adopt this methodology more quickly.
Growing interest in Bayesian models is shifting how evidence is being generated. While we expect some regulatory challenges regarding their use in study design, trials can become more flexible, more informative, and potentially faster once all partners are comfortable in running them.
Master protocols, baskets, umbrellas, and platforms
Master protocol trials are gaining traction in IBD [4]. Evaluating one or more interventions across one or more patient populations under a unified trial structure leads to trial efficiencies (reduced timelines, shared control groups, and the introduction of new trial arms without halting the study). Basket trials (investigating a single drug across multiple disease populations), umbrella trials (investigating multiple drugs within a single disease population), and platform trials (longitudinal designs in which interventions can be introduced and removed) all offer significant advantages compared with traditional IBD clinical trial designs.
PSI is running some of the first platform trials in IBD. It is a perfect therapeutic area for this design. Having a comprehensive and adaptable trial protocol means patients with IBD, presenting with heterogeneous symptoms and who react differently to different treatments at different times, can benefit from acutely tailored therapies.
Rethinking late-phase trial design
Innovation in trial design doesn’t resolve operational constraints if structural barriers remain unchanged.
- Washout periods
According to one KOL, washout periods are the single factor that most impacts enrollment. Following the FDA’s guidance, patients may have to wait up to 12 weeks on steroids (5 or more half-lives of prior therapy [5]) before they may be considered for trials. Sponsors can consider shorter washout periods, provided they are justified. - Steroid tapering
Taper schedules influence data integrity, durability of response, and translation into clinical practice. Recent guidance on steroid handling practices aims to standardize recommendations across IBD trials for screening/induction/maintenance and emphasizes expedited tapering and shorter, fixed-dosing periods that better reflect clinical care standards [6]. - Minimizing placebo use
A placebo arm is important in early-phase trials, where safety assessment takes priority over efficacy; however, in late-phase trials, using placebo when effective therapies exist raises ethical concerns and may deter patient participation, slow recruitment, or impact retention. Strategies to minimize the proportion of patients assigned to placebo include asymmetrical randomization, Bayesian design, active comparator arms, external historical controls, and shared placebo arms in trials under a Master Protocol. Sponsors could consider non-inferiority to an approved therapy (rather than efficacy versus placebo) or head-to-head trials with a reasonable chance of success.
Diversity: A needed parameter
As many as 95% of historical IBD trial participants identify as White or Caucasian, and only 20% of real-world patients may meet typical trial inclusion criteria, depending on protocol restrictiveness. Underrepresented phenotypes in IBD trials include:
- Perianal Crohn’s disease
- Stricturing disease
- Patients with a stoma
- Older-onset IBD
Broadening inclusion criteria can reduce screen failure rates; however, with increased heterogeneity, larger sample sizes or careful analytical approaches may be needed to preserve statistical power. Site selection will shift towards a more distributed model (however, additional site training may be required). However, broader inclusion criteria enhance representativeness and improve the translatability of data to clinical practice, strengthening regulator confidence.
Beyond disease diversity, one of the key themes from this year’s ECCO was that a “one size fits all” approach silences patients’ cultures, experiences, and voices, narrowing the applicability of findings.
The patient perspective
A leading speaker at ECCO emphasized the challenges regularly faced in patient recruitment. In IBD trials, a typical site may enroll just one patient per year, reflecting complex, multifactorial barriers including eligibility criteria, difficult protocols, a crowded landscape, and patient-related factors. Patients themselves were asked: “How would you improve trial enrollment?”
Responses included:
- Reduce the chance of receiving placebo
- Widen the eligibility criteria to allow patients who fail multiple therapies
- Widen the eligibility criteria to include subtypes of IBD frequently excluded from trials
- Incorporate virtual visits to reduce travel burden
- Reach out to underrepresented populations
The message was clear: simplify the experience and reduce the burden.
Treat-to-target
Treat-to-target (T2T), or adjusting a patient’s treatment specifically to reach a particular goal, is increasingly being embedded in the management of moderate-to-severe IBD. At this year’s ECCO, the VERDICT trial was frequently mentioned. Results in moderate-to-severe UC are widely anticipated [7] – as they may provide long-term evidence on whether intensive, strategy-driven disease control translates to durable disease modification. Key challenges in T2T trials include:
- Defining the level of mucosal healing associated with structural disease modification
- Patient and clinician acceptability of the tight monitoring standards required for regular evaluations
- How T2T stratifies patients towards precision medicine (and holistic, personalized care)
- Establishing cost- and time-efficient implementation in daily practice.
If disease modification becomes a central development objective, trials will require longer follow-up periods and structural endpoints, increasing trial length (and patient retention needs) and operational complexity. T2T is an evidence-based strategy, but in IBD it remains a work in progress.
Patient centricity in IBD trials
Moving beyond inflammation
In addition to the patient’s inflammatory phenotype and disease severity, factors related to their life stage, gender, ethnicity, comorbidities, psychological context, social determinants, and functional daily life must be considered in the treatment goal. Functional daily life must also be considered part of the treatment goal – for example, more than 20% of patients have to change their job due to IBD, and over a third must modify their current work [8].
While ECCO has recognized this with the creation of the Microscopic Colitis Working Group (MCWG) – which takes a broader view of inflammation in the context of other clinical factors – more work is required to perceive the patient in the context of their life and surroundings. Holistic care, multidisciplinary teams, and personalized medicine go hand in hand.
Shared decision-making among specialists and with the patient’s input is essential: To understand where patients will derive the greatest benefit from their treatment and, from a sponsor’s perspective, to increase adherence and improve investigator relationships.
Holistic care in IBD begins with the patient. Clinical trials are made possible by patients who commit their time, accept uncertainty, and bear the personal burden so that better treatments can be developed. As we look beyond remission defined by endoscopy and inflammatory biomarkers, quality of life evaluations and PROs are not secondary measures: they are central to understanding real therapeutic impact.
Broadening perspectives: Where next?
Refractory IBD
One clinician speaker at ECCO said the most challenging aspect of his work was managing refractory patients – those not responding or losing response to treatment (or in CD, not amenable to surgery) [9]. Despite positive developments in the availability of treatments effective across the spectrum of IBD, we still lack reliable predictive biomarkers, do not have clear strategies for optimal therapy sequencing, and face a therapeutic ceiling [10].
Difficult-to-treat IBD, including perianal disease, fibrostenotic disease, and multi-refractory IBD, among others, must be better represented in clinical trials. The next step would be to improve the characterization of refractory patients, potentially through refractory-dedicated trials. More challenging routes to providing solutions for patients with refractory disease include evidence-based combination and sequencing strategies, as well as novel targets and approaches, such as bispecific antibodies and cell therapies.
Clinical trials enrolling refractory IBD patients would require highly specialized site capabilities, including rigorous screening and patient selection, intensified safety monitoring, and comprehensive follow-up. The additional burden on sites should be partly alleviated by CRO support.
The gut
The gut-brain axis in IBD
Considering IBD holistically, i.e., as beyond inflammation, means perceiving IBD as gut–brain axis dysregulation.
- Persistent symptoms reflect sensitized neural pathways, immune activation, and psychological modulation
- Stress is often the main factor in patients with IBS and IBD – activation of the autonomic nervous system results in neuromuscular dysfunction, visceral hypersensitivity, microbiota alteration, and impaired barrier dysfunction
- Pain interference is somatic/central, rather than inflammatory
The future of holistic care in IBD will mean targeting the gut barrier, microbiome, nervous system, and the brain, and incorporating broader endpoint frameworks integrating functional and QoL measures.
Targeting the gut microbiome
The FMT (fecal microbiota transplantation) trials currently underway are promising: four out of six have shown positive results, and remission was achieved in 25–30% of patients. The main challenges in FMT include high logistical complexity, near-impossible standardization, and overwhelmingly unknown microbiome function [11].
Repositioning FMT endpoints from inducing remission to maintaining remission was widely agreed as more appropriate (they naturally promote homeostasis). For sponsors running FMT trials, longer follow-up periods, larger sample sizes, and more scrutiny on the definition of relapse would be expected.
Guidance on opportunistic infections
ECCO’s 2025 guidelines on opportunistic infections in IBD (an update to the 2021 guidelines; soon to be published [12]) introduce a more granular framework for assessing infection risk. Key updates included:
- Clearer vaccination pathways
- Recombinant zoster vaccinations for adult IBD patients
- Updated pneumococcal schedules
- Recommended RSV vaccination for patients aged ≥60 years
- Refinement of TB screening algorithms
The guidelines reflect a rapidly evolving therapeutic and infectious disease landscape, and have a particular impact on trials with non-anti-TNF biologics (e.g., vedolizumab, ustekinumab), which are associated with a lower risk of TB than anti-TNFs [13].
- For non-anti-TNF agents, the new guidelines recommend LTBI screening only if additional risk factors are present
- Patients with LTBI may begin therapy with α4β7 integrin inhibitors, anti-IL-12/23, anti-IL-23 (p19), or S1PR modulators concomitantly to LTBI treatment; however, anti-TNF or JAK inhibitor therapy should be delayed 3–4 weeks after starting LTBI treatment
Changes in recommendations for vaccination timing and TB management can influence screening duration, the speed of enrollment, and ultimately the feasibility of a trial in certain regions.
Global inequity and infrastructure variation
Results from the Lancet Gastroenterology and Hepatology Commission on Global IBD were presented at ECCO. IBD prevalence continues to increase around the world, including in regions where historic levels of IBD were low. Holistic care means understanding the patient’s surroundings and the barriers they face in the management of IBD (which are generally more pronounced in LMICs):
- Diagnostic delay, or infectious diseases mimicking IBD, complicating diagnosis
- Limited access to necessary healthcare infrastructure and tools, such as imaging (intestinal ultrasound, MRI), fecal calprotectin, genetic testing, and endoscopy
- Economic disparity or wealth inequality, limiting patient access to adequate healthcare (including access to specialized IBD care), and the public/private healthcare divide
- Limitations to access or quality of care being due to geography (urban/rural divide)
- Insufficient multidisciplinary frameworks and alignment leading to fragmented care
Infrastructure heterogeneity impacts screening timelines, diagnostic confirmation, monitoring intensity, and retention feasibility. It is critical that global, regional, and country variability is incorporated into feasibility and site selection.
Have we entered the era of mature holistic care in IBD?
Holistic IBD care is maturing and is reshaping clinical development.
Feasibility modeling must account for real-world factors, such as washout-related screen failures, steroid taper-related retention risk, vaccination and TB screening timelines, infrastructure variability, and the inclusion of complex phenotypes.
Protocol design, in turn, requires strategies to reduce placebo exposure, adaptive, Bayesian methodologies, broader endpoint hierarchies, and more robust safety oversight in refractory or difficult-to-treat patients.
Operational execution depends on multidisciplinary site and team preparedness, realistic enrollment assumptions, proactive retention planning for longer follow-up requirements, and careful assessment of region-specific infrastructure constraints.
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Abbreviations
Anti-TNF, anti-tumor necrosis factor;
CD, Crohn’s disease;
, European Crohn’s and Colitis Organisation;
FDA, US Food and Drug Administration;
FMT, fecal microbiota transplantation;
IBD, inflammatory bowel disease;
IBS, irritable bowel syndrome;
JAK, Janus kinase;
IL, interleukin;
LTBI, latent TB infection;
MCWG, Microscopic Colitis Working Group;
, magnetic resonance imaging;
PRO, patient-reported outcome;
, Respiratory syncytial virus;
S1PR, sphingosine-1-phosphate receptors;
T2T, treat-to-target;
TB, tuberculosis;
UC, ulcerative colitis.
References
1. U.S. Food and Drug Administration. Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products. 2026. Accessed February 2026; Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-bayesian-methodology-clinical-trials-drug-and-biological-products.
2. Khanna, S., et al., Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection. Drugs, 2022. 82(15): p. 1527–1538.
3. Solitano, V., et al., Placebo rates in randomized clinical trials of ulcerative colitis: an individual patient data meta-analysis. J Crohns Colitis, 2025. 19(10).
4. Honap, S., et al., Basket, Umbrella, and Platform Trials: The Potential for Master Protocol-Based Trials in Inflammatory Bowel Disease. Gastroenterology, 2024. 167(4): p. 636–642.e2.
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6. Hanžel, J., et al., An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease. Gastroenterology, 2025. 169(6): p. 1282–1293.
7. Jairath, V., et al., DOP050 Target achievement after 48 weeks of vedolizumab treatment in patients with moderate to severe Ulcerative Colitis: An interim analysis from the VERDICT trial. Journal of Crohn’s and Colitis, 2025. 19(Supplement_1): p. i180–i181.
8. Mustonen, A., et al., The impact of IBD on ability to work and study: a patient perspective. Scand J Gastroenterol, 2025. 60(1): p. 37–41.
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10. Alsoud, D., et al., Breaking the therapeutic ceiling in drug development in ulcerative colitis. The Lancet Gastroenterology & Hepatology, 2021. 6(7): p. 589–595.
11. Pasolli, E., et al., Extensive Unexplored Human Microbiome Diversity Revealed by Over 150,000 Genomes from Metagenomes Spanning Age, Geography, and Lifestyle. Cell, 2019. 176(3): p. 649–662.e20.
12. ECCO. New ECCO Guidelines on Opportunistic Infections in IBD – 2025 Update. 2025. Accessed February 2026; Available from: https://ecco-ibd.eu/publications/news/issues/2025/volume-20-issue-4/new-ecco-guidelines-on-opportunistic-infections-in-ibd-2025-update.
13. Kim, M.J., et al., Comparative risk of serious infections and tuberculosis in Korean patients with inflammatory bowel disease treated with non-anti-TNF biologics or anti-TNF-α agents: a nationwide population-based cohort study. Therap Adv Gastroenterol, 2024. 17: p. 17562848241265013.
