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BIOlogical therapy CYCLEs towards tailored, needs-driven, safer and cost-effective management of Crohn’s disease

Deliverables

"BIOCYCLE Scientific and financial progress report #2"

Scientific progress reports in compliance with the EC-Grant agreement at M36: -CHU and sCINNAMIC will put in place a management platform to: - maintain and monitor the work plan, the timely production of Deliverables, the Milestones including making alerts if deviation appears compared to tables 3.1.c (deliverables) and 3.2.a (Milestones); - To ensure that there is adequate collaboration between the clinical [SPARE] and non-clinical teams working on different work packages within the project; -Coordinate internal and contractual periodic reporting; -Coordinate financial and administrative issues: establish and maintain financial records, coordinate cost statements submission, follow-up of EC payments, distribute partner shares according to the Consortium Agreement. To administer project resources (human and financial); -Maintain contractual documents (EG-CA, Consortium Agreement) Special attention will be brought to consistency of management procedures across the SPARE study and the global BIOCYCLE Project including in terms of financial reporting. Clear information and assistance will be provided to the SPARE Study team including the Project Assistants of the Co-sponsors on the rules and expectations of the Commission for financial reporting especially e.g., for helping to gather the needed information among the clinical sites [third parties of the Co-sponsors]. CHU and sCINNAMIC (nested at CHU) will hold weekly short Project Management Meetings for enabling seamless day-to-day monitoring of the Project Progress and discuss possible managerial and financial issues encountered as well as how to solve specific problems. An extranet platform will be set up (member restricted access with individual login and password) to manage confidential information to be shared by all partners, such as: (i) Grant Agreement related documents (grant agreement and annexes including technical annex, consortium agreement), reports, charts, updated financial plans, etc., (ii) contact information (address book), (iii) information about activities conducted by each group (iv) access to scientific data bases, protocols, SOPs and internet‐based data management tools developed in BIOCYCLE, (v) communication rules and guidelines (vi) ethical and regulatory documents, and (vii) knowledge management‐related documents A web‐based reporting tool accessible from the extranet will be set up for the collection reports elements (scientific and financial reports). Harmonization and final edition of the periodic reports will be performed by CHU in collaboration with sCINNAMIC for the management‐related sections, based on the information compiled by the tool. -Monitor project progress, identification and trouble shooting of technical and organisational problems, strategic/technical co-ordination meetings; -Supervise achievements and propose evolution of the project according to those achievements; -Organise the yearly Steering Committee meeting in parallel to the ECCO congress (February 2016-2021) Attendees: CHU, sCINNAMIC, GETAID&Co-Sponsors, and WP-Leaders Typical agenda: - Evaluation of the level of achievements compared to the objectives, main problems/solutions and next steps; - Decisions for improving the efficiency of the consortium, re-orientation of parts of the work, if necessary, and means to implement them; - Approval of the propositions of the WP-Leaders, the Knowledge-Management Platform and the Data Management Platform; - Decision on the general structure for preparing the Scientific and financial reports (at M36)

Submission package

-Final version of study protocol as submitted to regulators / ethics committee(s) (no need to change deliverable if later amendments) -Registration number of clinical study in a WHO- or ICMJE- approved registry (Please note: Result posting for the study must be possible) -Approvals (ethics committees and national competent authority if applicable) required for invitation / enrolment of first subject in at least one clinical centre.

BIOCYCLE Website

The BIOCYCLE website will be the first-level information center on the general progress of the project. sCINNAMIC will be in charge of designing and updating the website which will give separate access to patients (associations), the medical community and other stakeholders (e.g., policymakers) needing information to better understand the objectives of the Project and how their achievement may have an impact on their own activities, decisions and orientation. The BIOCYCLE website will act as the first-level interface between the BIOCYCLE consortium and the outside world for collecting and sorting questions, redirecting specific queries to the right members of the consortium and, as such, to measure the interest of the public and stakeholders for this project. The website will also regularly post e.g., short newsletters on major advances of the BIOCYCLE Project, publications prepared during the Project and short tutorials. A secured access to the Participants will include templates, monitoring and reporting procedures for scientific and financial reporting, summaries on cross-disciplinary discussions, used definitions, meeting notes, access to general documentation.

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Publications

Systematic Review of Effects of Withdrawal of Immunomodulators or Biologic Agents From Patients With Inflammatory Bowel Disease

Author(s): Joana Torres, Ray K. Boyapati, Nicholas A. Kennedy, Edouard Louis, Jean-Frédéric Colombel, Jack Satsangi
Published in: Gastroenterology, Issue 149/7, 2015, Page(s) 1716-1730, ISSN 0016-5085
DOI: 10.1053/j.gastro.2015.08.055

How to Apply for and Secure EU Funding for Collaborative IBD Research Projects

Author(s): Jack Satsangi, Olivier Kitten, Marcela Chavez, Rahul Kalla, Nadege Prel, Marie-Alice Meuwis, Stephanie Scott, Illaria Bonetti, Nicholas T. Ventham, Edouard Louis
Published in: Journal of Crohn's and Colitis, Issue 10/3, 2016, Page(s) 363-370, ISSN 1873-9946
DOI: 10.1093/ecco-jcc/jjv237

European Crohn’s and Colitis Organisation Topical Review on Treatment Withdrawal [‘Exit Strategies’] in Inflammatory Bowel Disease

Author(s): Glen Doherty, Konstantinos H Katsanos, Johan Burisch, Matthieu Allez, Konstantinos Papamichael, Andreas Stallmach, Ren Mao, Ingrid Prytz Berset, Javier P Gisbert, Shaji Sebastian, Jarosław Kierkuś, Loris Lopetuso, Edyta Szymanska, Edouard Louis
Published in: Journal of Crohn's and Colitis, Issue 12/1, 2017, Page(s) 17-31, ISSN 1873-9946
DOI: 10.1093/ecco-jcc/jjx101

Stopping Biologics in IBD—What Is the Evidence?

Author(s): Edouard Louis
Published in: Inflammatory Bowel Diseases, 2018, ISSN 1078-0998
DOI: 10.1093/ibd/izx098

Integrated Care for Crohn’s Disease: A Plea for the Development of Clinical Decision Support Systems

Author(s): Nathalie Y Pauwen, Edouard Louis, Corey Siegel, Jean-Frederic Colombel, Jean Macq
Published in: Journal of Crohn's and Colitis, Issue 12/12, 2018, Page(s) 1499-1504, ISSN 1873-9946
DOI: 10.1093/ecco-jcc/jjy128

Tailoring Biologic or Immunomodulator Treatment Withdrawal in Inflammatory Bowel Disease

Author(s): Edouard Louis
Published in: Frontiers in Medicine, Issue 6, 2020, ISSN 2296-858X
DOI: 10.3389/fmed.2019.00302

Crohn’s disease patients’ and gastroenterologists’ perspectives towards de-escalating inflammatory bowel disease therapy

Author(s): Corey A. Siegel, Kimberly D. Thompson, Danielle Walls, Jan Gollins, Anne Buisson, Alain Olympie, Laurent Beaugerie, Jean-Frederic Colombel, Edouard Louis
Published in: Clinical Gastroenterology and Hepatology, 2019, ISSN 1542-3565
DOI: 10.1016/j.cgh.2019.11.062