The EU Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agency (HMA) published new guidelines on April 28, 2020 on the management of clinical trials during the COVID-19 pandemic. Serving as a set of harmonized recommendations across the EU, the regulators in Europe are concerned about the unprecedented impact wrought by the COVID-19 pandemic. Because SARS-CoV-2 has fundamentally constrained how clinical trials are actually conducted, Member States are afforded new flexibility and procedural simplifications during the raging public health crisis: top of mind is the safety of trial participants—and research staff—across the EU while ensuring that ongoing quality data generation is done so in a quality and consistent manner.
A Major Problem but Also an Opportunity
Member States have implemented unprecedented measures to deal with threats from the SARS-CoV-2 virus and their impact on the administration of clinical trials. From limited access to public facilities, including hospitals and clinics, to the need for patients to self-isolate and even quarantine of trial participants the status quo is gone in Europe for clinical research.
The EU has encouraged Member States to put forth specific national rules with a reminder that they should follow EU recommendations while leveraging related guidance offered by national medical and regulatory bodies such as the Italian Medicines Agency (AIFA) in Italy reports a group of Italian attorneys from Greenberg Traurig, LLP.
Due to the crisis resulting from the pandemic, AIFA issued two communications offering new heretofore not likely provisional flexibility during the crisis. The Greenberg Traurig attorneys note that Contract Research Organizations (CROS), for example, can implement measures that deviate from standard procedures when executing or managing clinical trials outside of clinical investigational sites as long as they ensure appropriate prior notification to ethics committees associated with involved sites—those involved must track all deviations. The AIFA edicts were announced via two communications dated March 12 and April 7, 2020. Regardless of newfound flexibility offered to Italian drug makers and CROs, they—and investigational sites—must ensure that they develop a comprehensive risk assessment plan and implement a “risk-proportionate action plan related to the extraordinary measures adopted” factoring in the Italian government’s provisions to deal with this epidemiological emergency.
‘Departures from Standard Operating Procedure’
Now and moving forward as the crisis unfolds AIFA authorizes a number of unprecedented flexibility such as:
· Direct delivery of the investigational medicinal products (IMP) from hospital pharmacies or warehouses to a subject’s home
· Sponsoring of home health care activities to be performed with the support of trained professionals and third-party providers
· Direct involvement of sponsors in trials
Greenberg Traurig, LLP
Greenberg Traurig, LLP is a globally ranked law firm with 40 offices around the world.