3 - Specific competencies and capacity to provide export advice
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Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
RIPPS - Réseau d'Investigation Pédiatrique des Produits de Santé Service de Pharmacologie Clinique (Hôpital Saint Vincent de Paul Groupe hospitalier Cochin – Saint Vincent de Paul) |
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| Number of peer reviewed publications in the last 5 years | 5 | Acta Paediatr. 2012 Mar;101(3):e137-9. doi: 10.1111/j.1651-2227.2011.02514.x. Epub 2011 Nov 22 Acta Paediatr. 2011 Apr;100(4):615-7. doi: 10.1111/j.1651-2227.2010.02103.x. Epub 2010 Dec 17. J Autism Dev Disord. 2013 May;43(5):1178-83. doi: 10.1007/s10803-012-1663-0. JPEN J Parenter Enteral Nutr. 2011 Nov;35(6):723-31. doi: 10.1177/0148607111415531. Epub 2011 Oct 5. http://dx.doi.org/10.2515/therapie/2011070 |
| Number of competitive grants obtained in the last 5 years | 25 | optimisation of the protocole, inclusion of patients, data analysis, manuscript writing, editing, research methodology, statistical analysis, proof reading etc |
| Access to expert groups | Yes | A methodological platform (C. Alberti, Martin Chalumeau : coordinator) which provide methodological support for clinical trials Methodological plateform expertise : - Development of Paediatric Investigation Plans (PIP) with G. Pillon an active member of RIPPS (O4CP…) - Phase I-II clinical trials: Pharmacokinetic/Pharmacodynamics, moddeling, clinical trials simulations. - Phase III clinical trials: optimised design for small sample sizes, Bayesian approach, surrogate endpoints. - Pharmaco-epidemiology. - Pharmaco-economics. - Evaluation of diagnostic tests. - Epidemiology. - Compliance studies and therapeutic monitoring. - Systematic reviews of clinical trials and evaluation of diagnostic tests. Access to expert groups disease dedicated : epilepsy, handicap, neuromuscular, endocrinology, nephrology, neonatalogy, autism. |
| Capacity to answer external scientific questions | Yes | RIPPS members organise - a teleconference each month to discuss new and ongoing protocoles,require an expertise on new protocoles - a face to face meeting every 4 to 6 months to organize the activities of the network discuss new projects etc... |
| Site feasibility | Yes | Feasibility is done for every specific study to evaluate the enrollment potential in relation to the inclusion/exclusion criteria. Feasibility is done both for academic studies or after request from a pharmaceutical company |
| Participant recruitment | Yes | A CRA is dedicated to monitor the recruitment of all project. 3 systematic monitoring visits are carreied out: a visit at the beginning of the study, one at the end and a visit during the study Central monitorring for all trials (once a month) regarding inclusion, quality control of the data (missing data, missing visits, uncomplete items in the CRF, protocol violations, Adverse events are also carried out on regular basis |
| Budget calculation for studies | Yes | Cost estimate are made when a study is proposed. Quote is made in function of the time spent on projects RIPPs looks for the conformity of time spent on the project and the financial plan. |