Dear Friends and Colleagues
A couple of years ago we established Paediatric European Digestive Diseases Clinical Research Network (PEDDCReN) and in doing so you put your name forward. With this email we are making you aware of the next phase of this project and hope you will be willing to contribute. The main aim is to identify and study rare and serious complications of paediatric inflammatory bowel disease and improve outcomes for our patients.
This has been made possible due to a very exciting achievement where PEDDCReN was part of a successful H2020 bid called PIBD SET Quality. Led by Prof Frank Ruemmele in Paris this is the first EU funded project of its kind in PIBD.
Rare Complications Study
Dear Friends and Colleagues,
We are excited to invite you to the Safety E-card for rare complications of PIBD.
About the project:
We have established an online registry of rare and serious complications of paediatric IBD by sending a monthly E-card to experts looking after children with IBD and collecting all responses to a dedicated database. This prospective study is part of a successful H2020 bid called PIBD-Safety Efficacy and Treatment Quality (PIBD-SET Quality). Led by Prof Frank Ruemmele in Paris; this is the first EU funded project of its kind in PIBD.
This project has been running for 6 months now and we have gathered more than 400 responses from PIBD experts across more than 10 different EU countries. These responses include 40+ reports of rare complications in PIBD.
How to get involved:
If you are not already and would like to be part of this study, please advise us at firstname.lastname@example.org and we will add your email address to the list. If you change your mind then let us know and we will remove your email address.
How it works:
1. The E-card is sent monthly to all our participants and is a yes/no questionnaire of whether you have seen one of these complications within the last month only. Most of the time, all you need to do is click ‘No’, however, if you would like to report any relevant complications please select ‘yes’.
2. When a rare complication is reported, we follow up with an eCRF asking for further information. This will be brief and will not include patient identifiable information, therefore informed consent is not required for most countries.
3. At some point, we will also collect denominator in order to calculate incidence rates and proceed to statistical analysis.
What we need:
All we need, is you to respond to the E-card when it arrives.
Please do pass on to other permanent staff in your unit and ask them to contact us with their email address if they are willing to participate, we will double check there is no duplication of reporting.
We look forward to having both the largest network of its kind in the World and a very high response rate.
Thanks for your support,
PIBD-SET Quality Team
Nick Croft (Paediatric Gastroenterologist), Chronis Kemos (Data Manager and Analyst) – London, UK
Lissy de Ridder, Martine Aarloom - Rotterdam
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Mirum Pharmaceuticals is striving to bring transformative medicines who have rare cholestastic liver conditions. In keeping with their mission they have instituted a a Phase 3 study called MARCH to evaluate the safety and efficacy of maralixibat in pediatric patients with PFIC. Eligible patients in this clinical study may help provide new insights into PFIC and could lead to the first approved drug therapy. For full details please visit https://pfictrial.com/