15 Dec 2020

The management of clinical trials in Italy during the COVID-19 spread emergency

During the spread of the Coronavirus pandemic, the monitoring activity at the clinical centers was extensively revised due to the severe impact, finding its way to be partly preserved in the experimental centers through the implementation of an intensified remote monitoring modality.

Virtual/Remote Site Monitoring solutions ensured the continuity of clinical studies on the side of the Companies in charge and the retention of data integrity despite the impossibility of the monitors to physically go to the centers for on-site visits.

In accordance with what communicated by AIFA (Italian Medicines Agency) in relation to the recent precautionary measures adopted by the Council of Ministers and the Ministry of Health, many CROs, pharmaceutical companies and non-profit promoters have applied or extended the smart-working method in order to guarantee business continuity without having to interrupt the activities related to clinical studies and offer maximum protection to the personnel involved, at the same time.

Also according to what reported by AIFA, the conduct of clinical studies must be managed observing common sense principles, upon the utmost safeguard of the participants in the studies and through adequate supervision by the main investigators (PI).

With regard to the Ethics Committees, without prejudice to the current legislation and the internal procedures of the individual Ethics Committees, their sessions will be allowed in web-conference mode or through other types of telematics, at an appropriate frequency according to the management of emergencies relating to the current circumstances.

As regards the monitoring of clinical trials, the Promoters are invited to draw up a risk assessment plan or to update the existing monitoring plan, to implement an action plan that takes into account the need to reduce unnecessary contacts in current COVID-19 emergency and obtain a balanced and appropriate compromise between the supervision by the promoter and the related risks.

First of all, it should be assessed whether the on-site monitoring visits can be replaced or, temporarily reduced in frequency, or deferred with the introduction and / or strengthening of centralized monitoring and central data revision.

In order to maintain control over the progress of the experimentation and the conditions of the subjects, it is recommended to intensify the exchange of information through the strengthening of off site-monitoring activities, normally in addition to the monitoring activity at the experimental centers, such as telephone contacts with the site, video conferences, e-mails and other online communication tools with the investigator and clinical staff.

However, if there are suitable guarantees to protect the fundamental rights and freedoms of the data subjects, in relation to the urgency or undelayable need for supervision by the Sponsor/CRO, other temporary monitoring methods may be implemented according to the ones established by the owner of data processing and in line with the security measures adopted by the owner him/herself, that consider the highest level of risk associated with this methodology.

The identification of the most appropriate systems for functionality, security, validation, for sharing documents and information, based on risk assessments that justify their use in compliance with the rights of the subjects is left to the promoter.
All alternative methods must be implemented in full guarantee that access occurs only to the documentation of the subjects included in the trials, limited to the period of involvement in the trial itself.

Such alternative solutions are to be considered exceptional dispensations limited to the period in which the emergency conditions persist; subsequently it will be necessary for the Sponsor/CRO to evaluate the impact of these different forms of monitoring and to foresee intense follow-up measures including an increased number of on-site visits to eventually fill the gaps due to the reduced frequency of monitoring at the experimental centers, as soon as the situation is normalized.

One of the follow-up measures to keep in mind is the need for data that has been monitored remotely to be monitored on-site.

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