Clinical Trial Regulation: Another Piece of the Puzzle

Another piece of the puzzle that will become the Italian clinical trials regulatory framework has been completed last week through the publication of Legislative Decree no. 52 of 2019. We had already talked about changes to clinical trials legislation in this previous post and some of the current changes had already been foreseen in such bill.

Here are the major changes:

  • The Italian pharmaceutical agency (AIFA) will be called to issue requirements for trial centers and specific weight will be given to the involvement of patients’ associations by the center in the protocol definition;
  • Patients associations will be involved also in the process of evaluation and authorization of clinical trials;
  • AIFA will publish data on authorized trial centers, along with curricula vitae of individuals involved in the conduct of the study;
  • AIFA will also need to set forth rules to guarantee the independence of the clinical trials and the absence of conflicts of interest in furtherance of section 9 of EU Regulation 536/2014;
  • In case of breach of terms and procedures relating to clinical trials, or of rules on independence and transparency, an ethical committee may be suspended;
  • New rules aimed at facilitating non-profit trials and observational studies (also post-market) will be introduced, which will allow the assignment of study data and their use for registration purposes.
  • Research methodologies and clinical trials conduct will be the subject matter of specific training courses offered, also as continuing medical education.

In conclusion, we need to wait for further rules before the puzzle is complete.

About Paola Sangiovanni

Partner of GITTI and Partners. Seasoned transactional and regulatory legal counsel with a thorough understanding of the life sciences industry.

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