October 15, 2020

Clinical trials: new rules for conflict of interests

The regulation on conflict of interest in clinical trials was recently amended by Article 11-bis of Law Decree No. 34 of May 19, 2020 (Decreto Rilancio), as amended by Law No. 77 of July 17, 2020.

Under previous legislation, the investigator was required to declare in advance to the facility where the clinical study took place the absence of: (i) any financial interest in the assets of the pharmaceutical company that owned the drug under study held by the himself/herself as well as by his/her spouse or cohabitant or relative within the second degree; and (ii) any relationships of dependence, counseling or collaboration, in any capacity, with the sponsor.

Conversely, under current regulation, the investigator shall disclose any financial interests connected with the proposed study and any relationships with the sponsor, whenever they occur. Subsequently, the competent Ethic Committee shall evaluate the investigator’s statement to assess whether a concrete conflict of interest exists that may jeopardize the independence and impartiality of the clinical trial.

The Ethics Committee shall also verify that neither the investigator nor a spouse or cohabitant holds shares in the pharmaceutical company that owns the drug under study.

The Ethics Committee shall carry out these assessments (i) as part of the preliminary procedure for drafting its opinion on the clinical trial and (ii) during the trial if new conflicts of interest arise.

This normative novelty removes a previous regulatory obstacle that impeded a researcher who was working with the Sponsor in a scientific capacity from participating as the investigator in a clinical trial. Indeed, under the current legislation, a researcher who is working with a Sponsor may become the investigator for a clinical trial upon approval from the Ethics Committee.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
Search by...
Search
Follow us on
Follow us on