Master “G. Benzi”: Introduction to Clinical Trial Disclosure & Data Transparency

On October 8, Massimo Zaninelli, CEO of Maxer Consulting, has held the lecture Introduction to Clinical Trial Disclosure & Data Transparency (CTD & DT) at the two-year Master on Regulatory Discipline “G. Benzi” – University of Pavia. CTD & DT, though is still relatively poorly known in Italy, is becoming increasingly important for clinical trials sponsors due to the attention of the EU and US regulatory authorities. The evolution and the importance of CTD & DT find confirmation in the imminent release of the EMA Clinical Trial Information System (CTIS) platform and the rapid progression of the’s Clinical Trial Modernizationprogram.

The lesson dealt with the following topics:

  • Clinical Trial Disclosure: EU legal basis e regulatory principles
  • The Applicant/Marketing Authorization Holder’s responsibility
  • As-Is: EudraCT, EU Clinical Trials Register, EMA Clinical Data
  • To-Be: Clinical trial Information System (CTIS)
  • Clinical Trial Results publication (Dir. 2001/20/EC)
  • Anonymization and Redaction (Policy 0070/2014)
  • Layperson summary (Regulation 536/2014)
  • Clinical Trial Disclosure in the US: FDAAA 801 and Final Rule
  • A game-changer for responsible Parties
  • Open issues.