US FDA updates its March 2020 norms to conduct human studies

Nandita Vijay, BengaluruMonday, September 6, 2021, 08:00 Hrs  [IST]

The US FDA, concerned on the safety of clinical trial subjects during the pandemic, has updated its March 2020 norms on conducting human studies on August 30, 2021. The global regulator which noted the Covid-19 as a public health emergency now insists that the clinical trial industry, investigators, and institutional Review Boards need to maintain compliance with good clinical practice (GCP), minimize risks to trial during the ongoing pandemic.

The move to update the earlier guidance came about after US FDA noted that with the outbreak of respiratory disease caused by a novel coronavirus, challenges could arise, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial participants become infected with Covid-19. Such problems could lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits to laboratory for testing.

In order to ensure smooth conduct of clinical trials which is critical for new drug launches, FDA outlines considerations to assist sponsors in assuring the safety of trial participants. Sponsors should consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify study conduct accordingly. In all cases, it is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them.

Further sponsors, in consultation with clinical investigators and Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), will need to determine that the protection of a participant’s safety, welfare, and rights is best served by continuing a study participant in the trial as per the protocol or by discontinuing the administration or use of the investigational product or even participation in the trial. Such decisions will depend on specific circumstances, including the nature of the investigational product, the ability to conduct appropriate safety monitoring.

Since trial participants may not be able to come to the investigational site for protocol-specified visits, sponsors should evaluate whether alternative methods for safety assessments via phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants.

In some cases, trial participants who no longer have access to investigational product or the investigational site may need additional safety monitoring on withdrawal of an active investigational treatment.

The need to put new processes in place or to modify existing processes will vary by the protocol and local situation. For example, this assessment could include consideration of whether it is appropriate to delay some assessments, or, if the study cannot be properly conducted under the existing protocol, whether to stop ongoing recruitment, or even withdraw trial participants. Covid-19 screening procedures are mandated at the site where a clinical trial is being conducted.