We inaugurate a new section of our blog dedicated to regulatory updates in the clinical field. Our Clinical Regulatory Affairs Department constantly monitors industry updates to ensure continuous updates to our staff and customers. We see below the main news of the month of June and July 2020.

The current situation generated by the spread of the Covid-19 infection is having a significant impact on all stages of treatment development. The main regulatory authorities are constantly updating the indications regarding clinical trials with Covid-19 patients. Here are the main novelties that emerged in Italy, Europe and the USA in June and in July 2020.

AIFA: Approval of clinical trials, Phase 1 centers, Covid-19 standard care 

In June, AIFA published a new circular on special and simplified procedures for the submission and approval of clinical trials on medicinal products, prospective pharmacological observational studies and therapeutic use programmes (c.d. compassionate uses). In view of the number of authorised clinical studies and the changes in the epidemiological scenario, AIFA has indicated that preliminary and incomplete study proposals will no longer be considered, but only applications for clinical trial authorisation, prospective pharmacological observational study protocols and full-form therapeutic use programmes.

In particular, the measure shall take into account:

  • applications for authorisation of the clinical trial phase 1, 2, 3 and 4;
  • requests to initiate prospective pharmacological observational studies (For the evaluation of retrospective observational drug studies, the procedure commonly applied for this type of study should be followed, which is not modified by the rules applied for the Covid-19 emergency);
  • therapeutic use programmes

With regard to the activation of Phase I clinical trials centres in the field of COVID-19 infections, the AIFA has provided for derogations from the requirements of the current rules (Determine AIFA 809/2015 and 415/2016). Bearing in mind the protection of the rights and safety of participants in clinical trials, AIFA, at the proposal of the GCP Inspectorate, has therefore identified with the determined 564/2020 the requirements reduced but essential in order to allow the start of clinical trials of Phase I COVID-19 in the widest possible number of health facilities. In addition, the Scientific Technical Commission (CTS) of the AIFA has provided a series of considerations regarding the definition of the standard of care (“standard of care“, SOC) in clinical trials in patients with COVID-19.

European Medicines Agency (EMA): observational studies COVID-19

The EMA recommendation on transparency of protocols and results of observational studies related to medicinal products for COVID-19, as well as collaboration between researchers, to ensure high-quality studies and scientific impact, shall be communicated. When planning observational studies, researchers should adhere to existing guidelines on the design and conduct of pharmacoepidemiological studies in order to generate reliable and reproducible evidence. The EMA also reminds researchers to publish all the protocols and reports of COVID-19 observational studies in the EU PAS register. The invitation of the EMA is supplemented by the publication of the article “Considerations for pharmacoepidemiological analyses in the SARS-Cov-2 pandemic”. The article provides recommendations to researchers, regulators and clinicians on how to conduct high quality research during the pandemic.

Food and Drug Administration (FDA): guidelines clinical trials COVID-19

Finally we report the publication by the FDA of two guidelines issued to simplify the review process and advice to start studies on the COVID-19 as quickly as possible.

  • The first guideline, “COVID-19 Public Health Emergency: General Considerations for Pre-lnd Meeting Requests for COVID-19 Related Drugs and Biological Products”, outlines a more efficient process for Sponsors to receive feedback from the agency on their support data with the aim of starting clinical trials as soon as possible. To this end, the guide shall provide the sponsors with clarity on the types of data and information they should provide to address clinical, non-clinical and quality considerations before submitting an application to initiate a clinical trial.
  • The second guideline is “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidancefor lndustry ”, provides the current FDA recommendations on clinical trials aimed at establishing the safety and effectiveness of products for COVID-19 (appropriate selection of patients, duration of study, effectiveness assessment, safety monitoring, etc.).

National Coordination Centre of Ethics Committees: Evaluation of studies on SARS-Cov-2 infection

The National Coordination Centre of Ethics Committees has prepared the note “Evaluation of studies on SARS-Cov-2 infection by the EC”, with the aim of supporting researchers and Ethics Committees in implementing appropriate pathways for evaluation by the Ethics Committees of studies on COVID-19. The note refers to the normative indications issued in recent months, including the recent Circular AIFA of 22 May on “Simplified procedures for studies and compassionate uses for the emergency from COVID-19”.