ECCO investigator-initiated study approval - promoting scientific IBD projects
This initative is meant to ensure the scientific quality of ECCO-approved or ECCO-funded studies, but not to act as Study Sponsor. The ECCO ClinCom will facilitate the conduct of studies from inception to completion. At the very least, independent appraisal of a project can be expected to improve the scientific content and outcome of the study. Endorsement of a protocol by ECCO can be expected to increase the chance of successful grant application for funding and ethics approval, which both require independent appraisal.
Consultancy: facilitating scientific projects and programme development
This initiative aims at advising on clinical study development, at facilitating comparison between studies and at ensuring that outcomes of clinical studies are relevant for the benefit of the patient. Independent appraisal and endorsement of scientific projects by ECCO extends beyond that achieved by conventional Advisory Boards. ECCO endorsement of the design and conduct of studies is likely to be viewed constructively by:
- regulatory authorities
- grant funding bodies
- ethics' committees
- editorial process of publication
Remuneration for these services is for the benefit of ECCO and not for individual members of ClinCom. Any individual conflict of interest (such as might happen through independent consulting arrangements) will be avoided by precluding that individual from the process, or other appropriate measures according to the project.
The ECCO ClinCom can act as a forum for developing scientific ideas related to IBD. This might include
- Exploring novel therapeutic strategies
- Considering the applicability of technology to IBD from a different field of work
- Placing translational science into context
Contact can be made with individual ClinCom members or through the Chair.
Open research studies
Outcome of pregnancies in female IBD patients treated with vedolizumab (CONCEIVE):
||University Hospitals of Leuven (Belgium), the Erasmus MC (Rotterdam, The Netherlands), the Shaare Zedek Medical Center (Jerusalem, Israel)|
|Purpose and outcome:||Very few data are available regarding pregnancy outcomes in female patients with IBD treated with vedolizumab. Expanding the existing study initiatives to a European level would certainly provide more data on the safety of vedolizumab in pregnancy and offspring. European research groups and individual IBD centers are invited to collaborate on this topic in a retrospective, multi-center cohort study.|
|Deadline to participate:
||July 1, 2018|
|Target group:||European research groups and individual IBD centers
|Results:||Submission of an abstract for ECCO 2019 and of a full manuscript shortly thereafter|
|Link to the accopanying letter:||CONCEIVE accompanying letter|