Preclinical and Clinical Trial Requirements
Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No. However, having conducted part of the medicinal product development (including clinical trials) in Italy may place the marketing authorization holder in a stronger position when negotiating the product’s price with AIFA (in case of reimbursed products).
While clinical trials may be conducted outside the EU, in such case the marketing authorization applicant must submit a statement certifying that all clinical trials have been carried out in compliance with the ethical requirements set forth in legislative decree 211/2003.
2. How are clinical trials funded?
Clinical trials conducted in Italy are often funded by pharmaceutical companies acting as trial sponsors. However, investigator-initiated studies are very common in Italy. In such cases, pharmaceutical companies may provide financial support.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Clinical trial protocols must include the objective(s), design, methodology, statistical aspects and organisation of the trial.
Before commencing a clinical trial, the sponsor must submit an application to the Ethics Committee competent for the clinical site. The application must include all data and supporting documents relating to the proposed clinical trial, including the protocol, which will be taken into account by the Ethics Committee when issuing its opinion.
Once a favourable opinion is obtained, the sponsor can apply for authorization with AIFA, which is the competent authority for issuing the authorization of all clinical trials of medicinal products, from Phase I to IV.
The sponsor can amend the protocol in the course of the clinical trial, provided that it notifies the Ethics Committee. In case of substantial amendments to the protocol that can impact on the safety of the trial subjects or modify the interpretation of the scientific documentation supporting the clinical trial or that are otherwise relevant to the conduct of the trial, the sponsor must inform both AIFA and the Ethics Committee of the reasons for and content of the amendments. If the Ethics Committee issues a negative opinion on the amendments to the protocol, the sponsor may not proceed with the trial on the basis of the amended protocol.
4. What are the requirements for consent by participants in clinical trials?
Participants in clinical trials must give their informed consent when deciding to take part in the trial. The informed consent must be:
- recorded in a written document, dated and signed;
- spontaneously given after the perspective participant has been duly informed about the nature, meaning, consequences and risks of the trial and after receiving the relevant documentation.
Notwithstanding the initial consent given, participants can decide to abandon the clinical trial at any time. Special rules apply to the consent given by minors and adults legally incapable of giving their consent, for whom the informed consent is given by their legal representative or by an authority, person or body in accordance with the applicable laws.
The Ethics Committee also evaluates the suitability of the methods and documents that will be used to inform the perspective participants and to obtain their informed consent when issuing its opinion.
5. May participants in clinical trials be compensated?
Article 1 of legislative decree 211/2003 forbids the offer, grant or request of financial incentives or other kind of benefits to participants in the clinical trials, except for allowances granted to healthy volunteers. In the sponsor is a public entity, allowances may be granted only within the limits of the budget available to it.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Legislative decree 211/2003 requires the sponsor to provide an insurance to compensate participants in clinical trial for all damages arising out of the experimental activity. The insurance policy must cover the liability of both the investigator and the sponsor.
Ministerial Decree of 14 July 2009 provides for the requirements of the insurance policy concerning maximum coverage, duration, franchise (none permitted) and exclusions from coverage. The insurance policy must be drafted in Italian, signed by the insurance company and include detailed reference to the clinical trials and its protocol and must be submitted by the sponsor to the Ethics Committee.