Global IBD Collaborative Research

Shaji Sebastian, ClinCom Chair and Murat Toruner, ClinCom Member

Shaji Sebastian 

Murat Toruner

In the past, IBD was believed to be predominantly a disease of the Western world. However, recent studies have shown a rapidly increasing incidence of IBD in newly developing areas such as the Middle East, South America and Asia. By the middle of this century, the prevalence of IBD in low and lower-middle income countries (LLMICs) and newly industrialised nations may surpass that in the West. At the same time, the compound prevalence in the Western world and increasing health care costs will add to the challenges in IBD care. As a result of these epidemiological trends, IBD is projected to be an increasing global health burden.

Posted in ECCO News, ECCO'23, Volume 18, Issue 4, Committee News, ClinCom


The new EMA Clinical Trial Information System (CTIS)

Tanja Doris Ute Kuehbacher, ClinCom Member

Tanja Kuehbacher

In the fast-paced world of medical research and drug development, efficient data management and transparent communication are critical factors for success. To address these challenges, the European Medicines Agency (EMA) has launched a new Clinical Trials Information System (CTIS) that went live on January 31, 2022 [1, 2]. The CTIS is the backbone of the Clinical Trials Regulation, which will harmonise the assessment and supervision of clinical trials in the European Union. There is a transition period until January 31, 2025. Any ongoing trial that has been approved under the Clinical Trial Directive will then fall under the Clinical Trials Regulation [1–3].

Posted in ECCO News, ECCO'23, Committee News, Volume 18, Issue 3, ClinCom


Best Investigator-Initiated Study Award at ECCO'23

Maria Chaparro, ClinCom Member

Maria Chaparro

The study entitled "Withdrawal of anti-tumour necrosis factor in Inflammatory Bowel Disease patients in remission: a randomised placebo-controlled clinical trial" received one of the two Best Investigator-Initiated Study Award at ECCO’23.

Biologic anti-TNF drugs have been a game changer for patients with Inflammatory Bowel Disease. However, long-term maintenance of these drugs may be associated with potential adverse events and high costs. Therefore, patients and physicians are wondering whether it is possible to discontinue these drugs without significantly increasing the risk of recurrence.

Posted in ECCO News, ECCO'23, Committee News, ClinCom, Volume 18, Issue 2


ClinCom Educational Courses at ECCO'23

Peter Bossuyt, ECCO Member

Peter Bossuyt

Designing, organising and performing clinical trials in IBD is a challenge. Drug development trials often follow the well-known pathways, with established endpoints and a more or less standardised study design. Things become more complicated when the clinical researcher departs from these trusted routes.  In this context, ClinCom (the Clinical Research Committee of ECCO) organised two courses during the last ECCO Congress in Copenhagen.

Posted in ECCO News, ECCO'23, Committee News, ClinCom, Volume 18, Issue 1


Report on the ECCO Topical Review: Roadmap to optimal peri-operative care in IBD

Shaji Sebastian, ClinCom Chair and Antonino Spinelli, ECCO Member

Shaji Sebastian

Antonino Spinelli

It is well known that the outcomes of surgery, and especially of IBD surgery, are not merely dependent on the operative procedure but are influenced by a number of factors before, during and after surgery. The multidisciplinary team involved in the care of IBD patients has the opportunity to optimise patient care and status prior to surgery to ensure optimal outcomes and reduce the risk of complications.

Posted in ECCO News, Committee News, ClinCom, GuiCom, Volume 17, Issue 4


Core Outcome Set for Real-World Observational Data in Inflammatory Bowel Disease

Peter Bossuyt, ClinCom Member

Peter Bossuyt

Multiple collaborations exist between ECCO Members in the collection of clinical data in a real-world setting. These observational data are an elegant addition to data from randomised controlled trials, as they reflect the efficacy and safety of clinical interventions in a more heterogeneous population who may not be included in randomised controlled trails and take into account the specific hurdles and challenges of everyday care for patients with IBD. The utility of real-world data, however, is dependent on the quality and homogeneity of the reported data. Data collection standardisation may enhance the quality of real-world evidence.

Posted in ECCO News, Committee News, ClinCom, Volume 17, Issue 3


Report from IIS Award Winner 2022: Dan Turner

Dan Turner, ECCO Member

Dan Turner
© Dan Turner

Academia can generate high-quality paediatric data during off-label use of drugs: the example of the prospective multicentre VEDOKIDS study

Remarkably, of the numerous biologics approved in adults with IBD, only infliximab and adalimumab have been approved in children. The long delay between approval of new drugs in adults versus children leads to their extensive off-label use, in the absence of appropriate dosing and safety data. Prospective paediatric data regarding vedolizumab are limited to a small phase 2 study (n=88; HUBBLE trial) focusing on pharmacokinetics. A paediatric phase 3 trial is underway but its completion is long overdue, also since vedolizumab is easily accessible in most countries without the constraints of study protocols. With that challenge in mind, once vedolizumab received approval in adults we initiated a prospective cohort study to explore the effectiveness, dosing and safety of vedolizumab in children. The VEDOKIDS study was sponsored by ECCO, The Paediatric Porto group of ESPGHAN and Takeda. Explicit demographic, clinical and safety data were prospectively recorded, and serum was collected for drug levels and stool for faecal calprotectin.

Posted in ECCO News, Committee News, ClinCom, ECCO'22, Volume 17, Issue 2


Report from IIS Award Winner 2022: Edouard Louis

Edouard Louis, ECCO Member

Edouard Louis
© Edouard Louis

The SPARE clinical trial

A treat-to-target strategy and tight disease control may improve outcome in Crohn’s Disease (CD). However, this approach may necessitate long-term use of biological agents and immunosuppression. Combination therapy with anti-TNF and antimetabolite agents is now well established in this context. These drugs may be associated with long-term risks and elevated costs. It is important to establish whether treatment de-escalation, once deep remission has been achieved, is feasible and whether this strategy may improve safety profile and costs without jeopardising disease control.

Posted in ECCO News, Committee News, ClinCom, ECCO'22, Volume 17, Issue 2


I-CARE: An imminent European success story in the field of IBD

Laurent Beaugerie, ClinCom Member

Laurent Beaugerie

The efficacy profile of IBD drugs is rapidly characterised by pivotal randomised controlled trials, but the safety profile of both old and new IBD drugs can only be established after years or decades of post-approval use. This is particularly true for relatively rare events, such as immunosuppression-related cancers. Clinical trials, meta-analyses and safety-dedicated registries are in general underpowered to evaluate the impact of IBD therapies on the risk of development of particular cancers. Data on clinical activity and phenotype of IBD are missing from nationwide administrative health databases, making it impossible to distinguish between the respective effects of IBD drugs and IBD activity on the risk of outcomes of particular interest, such as lymphomas.

Posted in ECCO News, Committee News, ClinCom, Volume 17, Issue 2


Report on the 8th ClinCom Workshop at ECCO’22

Shaji Sebastian, ClinCom Chair

Shaji Sebastian 

ClinCom Workshops are aimed at clinicians, surgeons and paediatricians and aim to provide an update on the latest clinical research trends in IBD. This year’s 8th ClinCom Workshop focused on two clinically relevant and practical topics.

Posted in ECCO News, Committee News, ClinCom, Congress News, ECCO'22, Volume 17, Issue 1