New training programme on the Clinical Trial Transparency

Maxer has completed the activity of training and updates for the professionals of Dompé, dedicated to the Clinical Trial Transparency (CTT) in the EU and the US.

The programme, divided into two sessions, analysed the legal and regulatory basis of the CTT according to the European (e.g. Regulation 536/2014) and the American (e.g. FDAAA, Section 801, 2007 and “Final Rule”, 2017) laws; furthermore, it has cleared the roles and responsibilities of the clinical trials sponsors’.

Specific in-depth discussions focused on:

• the EMA (EudraCT, EU Clinical Trials Register, and EMA Clinical Data) and FDA (ClinicalTrials.gov) for publishing clinical trials;
• the process of redaction for the registration dossier according to the EMA Policy 70/2014, the anonymisation techniques, and the criteria to decide whether to apply for the redaction of commercially confidential information or not
• the layperson summaries, whose drafting and publication will be mandatory six months after the Clinical Trials Information System (CTIS). CTIS is the official name of the EMA portal and database on which the current platforms will converge, and that will also host new collaboration tools for member states, sponsors, and EMA itself.

Beside the CTT training programmes, Maxer performs the uploading and the publication of full datasets and anonymised synopsis of clinical trials on both EudraCT and ClinicalTrials.gov; the anonymization of the registration dossier and the redaction of commercially confidential information; the editing of Standard Operating Procedure concerning the CTT processes, and the drafting of layperson summaries.