John Mansfield © ECCO

The 6^th ClinCom Workshop focussed on two current themes in IBD research: Evolving endpoints in clinical trials and comparative effectiveness research (CER).

Laurent Peyrin-Biroulet (Nancy, France) described the drivers that have led to the move from Crohn’s Disease Activity Index (CDAI) and Mayo scores to patient-reported outcomes (PROs) that just record clinical symptoms. The ultimate therapeutic goal is not only to reduce symptoms but also to return the patient to a normal life without disability. For Ulcerative Colitis (UC) the PRO uses rectal bleeding and stool frequency scores from the Mayo score, while for Crohn’s Disease (CD) abdominal pain and stool frequency scores are used. Many clinical trials also aim to show resolution of mucosal inflammation so endoscopic scores are frequently being used as co-primary endpoints with symptom scores. Some problems with PROs remain to be settled, especially the cut-off values for active disease, response and remission, and also the variability of patients’ assessment of loose stools and rectal bleeding.

Marc Ferrante  ©  ECCO

Following the success of the previous workshops, the Clinical Research Committee (ClinCom) of ECCO will run a sixth workshop in 2018.

During past years, endpoints in clinical trials for patients with Inflammatory Bowel Disease (IBD) have evolved substantially. Initially we mainly aimed for clinical remission, but it has become obvious that this is certainly insufficient to alter the natural history of the disease.