3 - Specific competencies and capacity to provide export advice
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Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PRINTO - Pediatric Rheumatology International Trials Organisation |
|
| Number of peer reviewed publications in the last 5 years | 43 | For most of the publications (either academic or industry-sponsored) the paper is written by the PRINTO international coordinating centres. For academic studies also the analysis is done centrally for most of the studies |
| Number of competitive grants obtained in the last 5 years | 4 | see list of publication on printo website at www.printo.it |
| Access to expert groups | Yes | The PRINTO Chairman is the current president of the Pediatric Rheumatology European Society (PRES) |
| Capacity to answer external scientific questions | Yes | The entire PRINTO staff (12 people) is working full-time to answer daily scientific questions. In particular, for 4 trials industry sponsored the PRINTO staff is evaluating, independently from company, the primary outcome of the trial. PRINTO staff receive via fax the case report forms related to the primary outcome and provide the assessment directly to the centre (see Ruperto et al Efficacy and safety of abatacept in children with juvenile idiopathic arthritis: A randomized, double-blind, placebo-controlled withdrawal trial. Lancet 2008;372(9636):383-391.) |
| 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 | Data collection is done entirely by PRINTO online via PRINTO website for academic studies; monitoring for academic studies is done through the use of standardises and validated questionnaires (no local monitoring available). For pharma companies, we monitor the quality of the primary outcome data by receiving the related case report forms via fax; in addition we perform the evaluation of response to therapy on behalf of the company. |
| Budget calculation for studies | Yes | For company sponsored studies PRINTO request centrally to all companies 2 provisions: 1) that the drug is provided for free to all children enrolled until the drug is labelled for the disease in the participating country or is beneficial to the child; 2) a minimum per patient fee, equal for all, is required to be given to all participating centres irrespective of the country of origin |