On 29 April 2021 the BMC Medical Ethics published the article “Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project” written by the DEEP-2 Study trial leaders and Ethics board members.
The article was aimed to evaluate the impact of the different local and national rules and procedures and of their complexity on the paediatric trial authorisation process in different EU and non-EU countries in terms of timelines for the final EC approval and CA authorisation from the preparation of submission package to the release of authorisation and approval.
The main results shown that the authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries.
DEEP-2 is a multi-centre, randomised, open-label, non-inferiority active-controlled efficacy-safety trial involving paediatric patients from 1 month to less than 18 years affected by transfusion-dependent haemoglobinopathies (DEEP-2; EudraCT 2012–000353-31; NCT01825512) performed according to a Paediatric Investigation Plan (PIP) agreed by PDCO (P/0357/2016). The study is part of the EU funded project “DEferiprone Evaluation in Paediatrics” (DEEP, FP7 HEALTH-F4-2010-261483) coordinated by CVBF. The study was based on the setting up of a unique submission package to ECs and CAs based on GCP and other specific paediatric EU requirements, case by case adaptation of this package according to the national frameworks in force at the time of the submission in each involved country.
Authors acknowledged the contribution given by TEDDY Network providing access to its regulatory database.
Read the entire article here.