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.

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