The COVID-19 epidemic has influenced and continues to influence the progress of clinical trials; ICMRA talks about prioritization of studies on COVID-19 with the aim of intensifying global collaboration and accelerating the development and evaluation of therapies. The main regulatory authorities are constantly updating the reports on the pandemic and are supplementing new guidelines in compliance with the rules. Here are the main news that emerged in Italy and Europe in August and September 2020.

The webinar EMA EMA Clinical Trial Information System Webinar: Dynamic Demo of Sponsor Workspace– scheduled for September 21st will demonstrate the features to create a Clinical-Trials application-in the Clinical Trials lnformation System (CTIS).

AIFA: corrigendum to “Report on drug use during the COVID-19 epidemic” and publication of guidelines for participation in clinical trials

The report on the use of medicines during the COVID-19 epidemic was presented, thanks to the data developed by the National Observatory on the Use of Medicines (Osmed) of the AIFA.

It should be noted that the National Coordination Centre of the Territorial Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices has made some changes to the Contract for the conduct of clinical trials on medicinal products, following some comments from stakeholders that have been deemed appropriate.
In addition, it should be noted that the Coordination Centre has defined and published the guidelines for the collection of the informed consent necessary for participation in clinical trials.

EUROPEAN COMMISSION: publication of new version of Q&A

Please note that the European Commission has published the new version (2.4, draft) of the Q&A “Clinical trials regulation (EU) no 536/2014 questions & answers”. The following are some of the questions addressed:

  • 1.7. “What is not considered as “normal clinical practice”?
  • 1.19 “What are the languages requirements for documents that constitute part I of the application dossier?
  • 2.10 “How will missing or incomplete documents in an application for the subsequent addition of a Member State (article 14) be addressed?”.
  • 2.11 “Can the decision on part I of a clinical trial application be changed at the moment of the addition of a Member State Concerned (article 14)?”
  • 2.12 “Can a subsequent addition of a Member State Concerned (art. 14) be submitted if another addition of a Member State Concerned (art. 14) is ongoing?
  • 2.13 “How will missing or incomplete documents in the part II application that follows a previously submitted part I application (article 11 – partial submission) be addressed?
  • 7.19 “How should RSI for the development of biosimilar drug products be written?”
  • Annex II “Annex II: Language requirements for part I documents

The European Commission has also published a technical notice to the Sponsors regarding compliance with EU legislation for clinical trials following the exit of the UK from the EU (scheduled for 31 December 2020). The notice recalls that according to Directive 2001/20/EC, the qualified person and the sponsor or legal representative of a clinical trial must be established in the territory of the EU/EEA.

EMA: approval of prioritisation of clinical trials on COVID-19 and publication of a new Q&A and guidelines

EMA ha approvato la dichiarazione congiunta Sulla prioritizzazione degli Studi clinici sul COVID-19 pubblicata dall’ICMRA (International Coalition of Medicines Regulatory Authorities). Drug regulatory authorities around the world jointly developed this statement to intensify global collaboration in order to facilitate and accelerate the development and evaluation of therapies, diagnostics and vaccines against COVID-19. In this statement, the authorities describe the key features of clinical trials that are most likely to generate the necessary evidence to enable accelerated approval of potential treatments and vaccines against COVID-19.

The publication by the ICH of a new Question and Answer regarding the clinical and non-clinical assessment of the prolongation of the QT/Qtc interval and the pro-rhythmic potential shall be notified. In particular, Q&A describes clinical and non-clinical risk assessment strategies to inform about the potential risk of proactivity and to contribute to the design of clinical trials.

Notice of the publication by the EMA of the guideline Preparedness of medicines’ clinical trials in paediatrics” which describes the recommendations of the Enpr-EMA working group {European Network of Paediatric Research at the European Medicines Agency) concerning the preparation of clinics/trials in the paediatric population.

ICMRA: new reports on COVID-19

It should also be noted that in July the regulatory authorities of medicines worldwide published on the ICMRA website several reports on the subject of COVID-19, following specific seminars, summarised below:

It should also be noted that in July the regulatory authorities for medicines worldwide published on the ICMRA website several reports on the subject of COVID-19, following specific seminars, summarised below:

  1. A report on the development of vaccines against COVID-19 has been published. The report covers two key topics:
  • data from laboratory, animal and human studies necessary to enable the initiation of phase 3 clinical trials for a vaccine against COVID-19; and
  • considerations on study design for phase 3 clinical trials.
  1. A report was published on the acceptability of several primary endpoints in clinical trials conducted for the development of treatments for COVID-19.
  2. A report has been published on observational studies and real-world data (real-world data) in the context of COVID-19. The report focuses on surveillance and surveillance of vaccines, collaboration on studies during pregnancy and the creation of cohorts of international patients.In this context, EMA presented the infrastructure it has created to monitor the safety of vaccines when they will be used in daily clinical practice across Europe

FOOD AND DRUG ADMINISTRATION (FDA): new guidelines for clinical trials

It is hereby notified that FDA has added additions to the Questions and Answers Appendix (Q&A) in the Guideline entitled “Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency”. The integrations focus on gathering informed consensus and how to document study visits when using video conferencing. We also note the publication by the FDA of a series of guidelines that provide recommendations regarding eligibility criteria for clinical trials on drugs or biological products for the treatment of cancer:

In addition, the FDA also publishes the following guidelines:

Si notifica la pubblicazione da parte di FDA di una linea GuidaCivil Money Penalties Relating to the Clinical Data Bank, Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff which provides recommendations for civil penalties in cash against the responsible parties and/or registrations and/or results presenters at the Clinic/Tria/s. gov database. . In particular, it defines which procedures apply when an FDA Center (CDER, CBER, etc.) asks for civil sanctions in cash and what amounts of cash civil penalty may be claimed for (1) not having registered and/or not having published the information on the results requested by the Clinica/ database, {2) have sent false or misleading information to the database, (3) have not submitted the certification required by the FDA or (4) have knowingly submitted a false certification to the FDA.