Clinical research is a fundamental pillar for the progress of medicine and the development of new therapies. The role of the Ethics Committees (ECs), independent bodies responsible for evaluating and approving trials, is a crucial element in ensuring ethical and safe clinical trials, ensuring that participants’ rights, safety and well-being are protected.
In the past, the fragmentation of Ethics Committees and the absence of standardised procedures have slowed down the start-up of clinical trials making the country less competitive at European level. However, the management of approval processes, while aimed at ensuring high standards of safety and ethics, has always been an organizational challenge.
In May 2023, the Ministry of Health initiated a reform of the Ethics Committees system to make the assessment process more efficient, harmonised and predictable, aligning it with European regulations such as the Medical Device Regulation (MDR 2017/745).
1. Bureaucracy in Clinical Research: Challenges and Limits
1.1 The role of Ethics Committees
The Ethics Committees play an essential role in ensuring that clinical research is conducted in an ethical manner and in accordance with current regulations. However, the previous system had several limitations:
- Fragmentation: Prior to the reform, there were over 90 local ECs, with management varying from region to region.
- Long approval times: Ethical assessments could take months, slowing the start of clinical trials.
- Non-uniform procedures: Each EC adopted different criteria, increasing uncertainty for sponsors and Principal Investigators (PI).
- Difficulties in multicentre trials: The coordinated management between several experimental centers was complex, causing delays due to duplications and inconsistencies.
These critical issues have led many sponsors and manufacturers of medical devices to choose countries with more streamlined authorisation processes, thus reducing the attractiveness of clinical research in Italy.
2. The Ethics Committee Reform: News and Benefits
To meet these needs, the Ministry of Health has introduced a reorganisation of the system of Ethics Committees, bringing the following innovations:
2.1 Reduction in the number of ethics committees
- From more than 90 to about 40 Territorial Ethics Committees (CET):
The reduction of the entities involved eliminates overlaps and reduces valuation discrepancies. - Specialization of CETs:
The new CETs are organised to specialise in specific areas of clinical research, such as medical devices.
✅ Benefit: Faster processes and more consistent evaluations.
2.2 Standardised Procedures and Predictable Approval Times
- Adoption of uniform evaluation criteria:
The introduction of common standards for all CTEs reduces the time-consuming delays due to different procedures. - Defined maximum response times:
This ensures greater predictability, allowing clinical trials to start on time.
✅ Benefit: Reduced uncertainties for sponsors and PI, with improved timing.
2.3 Harmonization with European Standards
- Alignment with MDR 2017/745:
The reform ensures that ethical assessments comply with EU regulations for clinical trials on medical devices. - Increased regulatory coordination:
A harmonised system reduces the risk of regulatory misalignment with European standards.
✅ Advantage: A more efficient and competitive system on an international scale.
3. Impact of the Reform on Clinical Research
3.1 Acceleration of Startup Times
The reform has reduced the time taken to approve clinical trials by making new CETs more efficient and standardizing procedures.
3.2 Attractiveness for International Manufacturers
A more streamlined and transparent authorisation process favours investment in clinical research, increasing Italy’s attractiveness on the international market.
3.3 Support for Researchers and Sponsors
More efficient management allows Principal Investigators (PIs) and sponsors to focus more on the science, reducing red tape and uncertainties associated with authorisation procedures.
4. The Role of We4 Clinical Research
We4 Clinical Research is a strategic partner to support sponsors, manufacturers and research centers in adapting to the new structure of the Ethics Committees. Here’s how to:
- Structured submission management: Standardisation and preparation of dossiers to ensure consistency and compliance with CET requirements.
- Specialist team: Professionals with expertise in document review and regulatory skills that facilitate the approval process.
- Effective communication: Proactive coordination between sponsor, manufacturer and CET to avoid duplication and delays.
- Regulatory advice: Support in the interpretation and application of regulations, including those required by MDR 2017/745.
- Regulatory monitoring: Continuous updates on procedures and requirements for experimental sites.
- Optimisation of clinical trials: Operational advice for more efficient management of clinical trials.
5. The Future of Clinical Research in Italy
The reorganisation of the Ethics Committees represents a fundamental step towards reducing bureaucracy in clinical research in Italy. With a slimmer structure, standardised procedures and alignment to EU standards, the system becomes more efficient, ensuring rigorous ethical assessments and faster start times for clinical trials.
With the experience of We4 Clinical Research, sponsors and Principal Investigators (PI) can successfully tackle the new authorisation process, helping to make Italy a true leader at international level in the field of clinical research.
