Given the data of recent weeks, we can say that the COVID-19 is intensifying again its percentage of infections and with this also its victims, bringing the number of positives to a few thousand in a few days. In an effort to meet the needs of their fellow citizens, Government agencies and regulatory agencies are constantly working to provide timely updates through the publication of new releases and guidelines that allow for effective and safe management of ongoing and ongoing clinical trials during the pandemic. Following the main news emerged in Italy, Europe and the USA in October and November.

AIFA: Update of AIFA releases with reference to clinical trials during COVID-19, publication of documentation and ways to harmonise clinical trials start-up processes (MD related), management of AIFA monitoring registers

Publication by AIFA of the press release “Clinical trials management in Italy under emergency COVID-19 (Update of 17 September 2020)” (in update of the AIFA releases published on 12 March and 7 April 2020). The communication aims to provide further guidance on the management of clinical trials and substantive amendments in Italy following the exceptional restrictive measures introduced by the Italian Government in the context of the fight against the pandemic by COVID-19, as well as following the maintenance of emergency and urgent provisions aimed at containing the spread of the virus referred to in Decree-Law July 30, 2020, n. 83.

Notice is given of the publication by AIFA of the document “Contract for the conduct of the Clinical Profit Investigation of Medical Devices”, with the aim of providing Ethics and Health Companies Committees with a useful tool to promote harmonisation in the processes of approval and launch of research projects, helping to reduce unnecessary delays, albeit in a phase of transition, waiting for the European Regulation 2017/745 to become operational.

We report the publication by AIFA of the communication How to register patients in the AIFA monitoring registers, depending on citizenship and status of membership in the National Health Service, aimed at making explicit to the Users of the Monitoring Registers the methods of registration of treatments within the AIFA platform according to the citizenship of patients and their status of membership in the national health service (SSN).

EMA: Implementation of IRIS, and publication of new draft guidelines for record management in clinical trials

Publication by EMA of the draft guideline “Guideline on registry-based studies” which describes methodological, legal and operational aspects on the use of records in clinical trials. We would like to point out the virtual workshop for the presentation of the draft guideline on 19 October 2020: an opportunity to discuss the topic with the main stakeholders.

We communicate the update by EMA of the internet page “Patient registries to publish the draft guideline “Draft guideline on registry-based studies” with the intention of publishing the final document in 2021.

EMA updates the Clinical Trial Regulation” webpage to report that in November 2020 an audit will be performed to the CTIS (Clinical Trials Information System). The system is expected to come into operation in December 2021.

Notice is given of the publication by EMA of the document “Questions and answers on Data Monitoring Committees issues” with the aim of complementing the CHMP Data Monitoring Committee guidelines by providing clarification on the role and need for a Data Monitoring Committee (DMC) in the different stages of drug development and throughout the life cycle of the product, as well as responsibilities for the implementation of decisions by the DMC.

Notice is given of the publication by EMA of the draft guideline “Guideline on the clinical Investigation of human normal 5 immunoglobulin for intravenous administration (Ivig)” for the public consultation. Comments must be sent no later than 13/01/2021.

We communicate the implementation by EMA of the online platform “IRIS Regulatory & Scientific Information Management Platform” to request “scientific advice”: the IRIS platform will provide applicants and the EMA with a shared space to submit requests, communicate, share information and provide documents concerning each scientific advice procedure.

Publication by EMA of the document European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance”, which addresses a series of questions that applicants for scientific advice or protocol assistance may have.

FDA: Publication of new safety guidelines for sponsors and patients

Notice of FDA publication of the FDA Guidance on Conduct of ClinicalTrials of Medical Products During COVID-19 Public Health Emergency” general considerations to assist sponsors in ensuring the safety of study participants while maintaining compliance with good clinical practice (GCP) and minimise the integrity risks of the trial throughout the duration of the public health emergency COVID-19.