Tag Archives: clinical trial regulation

Five Key Takeaways from Our Seminar on Clinical Trials

If you missed our seminar on clinical trials on January 16, here are five key takeaways to help you understand the changing regulatory environment in Europe and Italy.

  1. Be ready for a new regulatory landscape

The recent clinical trials regulatory overhaul within the EU aims at fostering research and facilitating the tasks of all actors involved in this area. However, delays in the implementation of such new legislation are posing an actual risk for the entire sector throughout the EU, while competition from emerging economies is getting stronger.

  1. Harmonized, but not enough

In several areas, such as observational studies or ethical committee’s assessments, a unified approach at European level is yet to be adopted. This leaves a lot of fragmentation among the various countries and a lot of work to be done at local level in order to ensure compliance with applicable regulations. Be prepared to deal with such inconveniences, in particular in the pharmaceutical sector.

  1. Changes in data protection laws offer new opportunities but challenges remain

GDPR brought new harmonized provisions to improve and support the use of data for the purpose of conducting research. However, guidance from national data protection and regulatory authorities in areas such as legal grounds for processing and secondary use is far from established. Moreover, different EU countries continue to adopt opposite approaches when it comes to consent and legitimate interest as valid legal grounds for data processing in the framework of clinical research. Data protection compliance will therefore continue to require local check-ups.

  1. New opportunities for independent research

Recent regulatory changes in Italy are being implemented to foster independent not-for-profit research in the clinical area. The new regulations, which are about to be adopted, envisage new opportunities for the participation of private actors in independent research and allow not-for-profit research institutions to better exploit the results of their research. The potential for conflicts remain and caution should be exercised within public-private relationships, but there is hope that new paradigms of collaboration will see the light.

  1. A new world of evidence is out there

More and more projects in the clinical research field involve real world data and real world evidence, gathered in a number of different ways outside the rigid protocols of a controlled study, whether through medical devices or other data collection instruments. Real world data are key to understanding how treatments work in reality and developing new healthcare paths. However, both clinicians and private actors are operating in uncharted territories and the line between studies and alternative research projects is thinner than you may expect. Be mindful of the regulatory and compliance ramifications of these new powerful tools.

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.