During the Enpr-EMA seventh annual workshop, held at the EMA in London, on Thursday 28 May, 2015, it was agreed to ask all Enpr-EMA registered networks to provide a short written paragraph with regards to any news or achievements which each network considers as being important and which has happened since the last Enpr-EMA workshop in June 2014.
The summary of the most relevant TEDDY initiatives conducted in the last year has been prepared and sent to Enpr-EMA and is available below.
Database of Paediatric Clinical trial centres
TEDDY collected general information on a total of 380 investigational centres in EU and non-EU countries participating in paediatric research. In order to map the expertise and competences of these centres a survey is planned to collect information on fields of interest, equipment for clinical trials available in the centre, participation in research projects and availability of electronic tools, details on the scientific activity and paediatric clinical trials/studies performed, cross competences related to paediatric clinical trials, e.g. ethics, regulatory and governance issues. The results will be made available to Enpr-EMA and could be used in the implementation phase of EPCTRI, the proposed European Paediatric Clinical Trials Research Infrastructure.
European Paediatric Medicines Database (EPMD)
TEDDY currently manages a database containing information on paediatric medicinal products authorised by the European Medicine Agency (EMA) under the centralised procedure related to:
- Medicinal products authorised by EMA for the paediatric use including details on indication, age for which the drug is approved, formulations, off-patent status, PIPs, OD status.
- Paediatric clinical trials at the time of the approval, including type, phase, experimental population,controls, biomarkers; other studies on the medicinal product in children are also included.
A report about information on EMA authorised drugs with a paediatric indication is periodically produced and disseminated throughout the Network. The last report is available here in PDF format:
Periodic report on drugs approved for children under the EU Centralised Procedure
Annex_List of the paediatric MAs/variations in 2014
Inventory of the Ethical and Regulatory procedures for CT approval in EU and non-EU countries
TEDDY created a database containing information on the relevant local and national requirements and procedures to apply for ECs and concerned competent authorities’ authorization and to carry out the Clinical Trial Application in several European and non-European Countries. Information is continuously updated and support for the CT application is available on demand for national/multinational/EU/non-EU studies.
Provision of regulatory and methodological expertise to paediatric trial sponsors
TEDDY-CVBF, as partner of GRiP (Global Research in Paediatrics), is leading international expert groups working on innovative methodological issues. In particular, these attain to:
- Implementation of alternative inferential methods (M&S, extrapolation, innovative statistical methods) for demonstrating efficacy and safety in paediatric population.
- Provision of ethical and governance oversight and recommendations on the secondary use and sharing of data from electronic health care paediatric databases.
Promotion and participation in paediatric clinical trials
The TEDDY Network promoted participation of several of its members in FP7 and Horizon2020 calls related to paediatric clinical trials, some of which are ongoing in the considered period: CloSed, DEEP, GAPP, NeoMero, NeoVanc.