In order to keep building on the contact that was established the previous years and aiming to foster collaboration among IBD National Study Groups in the framework of clinical studies further, the Clinical Research Committee of ECCO (ClinCom) is once again organising a National Study Group meeting at the next 14th Congress of ECCO in Copenhagen.
- Date: March 6, 2019 (Wednesday)
- Time: 17:00-19:00
- Place: Bella Center, Copenhagen
|Clinical Study Protocol: Study Synopsis|
During the meeting, a time slot is kept for the presentation of new study project proposals. We think ClinCom can help you establishing a network, and performing a critical review of your studies to optimize study protocols and to help avoid redundant or scientifically questionable research efforts.
The assessment of a clinical research protocol encompasses a 2-stage process. During the first stage, applicants are called upon to provide a study synopsis including background, design, objectives, outcome parameters, major inclusion and exclusion criteria, statistics, and co-variates not exceeding 4 pages (the template for this first phase is attached). Once this 1st stage application is submitted, the project will be reviewed by ClinCom and we will come back to you either supporting or declining the presentation at the National Study Group Meeting at the next 14thCongress of ECCO. Finally, after this meeting, ClinCom will respond to the applicant either encouraging or declining the submission of a full protocol.
If you are interested in submitting a study proposal and presenting it at the 4th IBD National Study Group meeting, please take into consideration the following information:
- Applicants need to be individual ECCO Members.
- The study should be multicentric, executed predominantly in Europe.
- Proposed by an independent researcher.
- The investigation must be independent of the industry interests.
- Ideally, it should be a study with a simple and practical design, in which the great advantage of sharing with the IBD National study group is recruiting a high number of patients. In this sense, ideally the study should be observational and non-interventional (either retrospective or prospective).
- Randomized Clinical Trials are not recommended as these studies generally require a highly complex design.
Please note that ECCO is happy to facilitate this meeting for IBD National Study Groups to enhance international collaboration. The main contribution of ECCO ClinCom to these projects is scientific review and dissemination. However, ECCO is not providing financial or logistical support to these studies. Furthermore, please keep in mind that the review by ClinCom is not an ECCO endorsement to the project.
On behalf of ClinCom, thank you very much in advance.