Contributed Commentary by Peter Tarasov

May 13, 2020 | The Food and Drug Administration (FDA), like everyone one in American society today, is having to adapt its oversight and enforcement of clinical studies to be more flexible while still protecting the safety and rights of study participants and staff. This is clearly harder than it sounds.

With its most recent update to the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, the FDA has weighed in on a number of questions concerning remote monitoring, obtaining informed consent from afar and reimbursement for FDA-approved, commercially available products used in a study.

One area that is particularly interesting is the logistics associated with administration of infusion products. The question is: "If certain patients may no longer be able to travel to a central location for protocol-based treatment, can the investigational product intended for infusion be shipped to a local health care provider to administer the infusion to a patient while still maintaining integrity of the trial?"

The FDA suggests that sponsors consider the feasibility of shipping IP to alternate, presumably safer, closer or more easily reachable locations where infusions can be administered.  It’s impossible to overstate the importance of ensuring these alternate infusion locations have physicians and staff experienced with infusion products, as well as their proper storage and administration. Sponsors will need to work with sites to ensure that alternate administration sites are properly vetted and IP transport is safely handled while maintaining the interests of the study subjects as the primary focus.

An important note is that local health care providers (HPCs) that are administering infusion in line with accepted clinical practices do not need to be listed on Form FDA 1572 as subinvestigators. They should, however, be logged in site records and reviewed and approved by the IRB.  “In contrast, if a sponsor will be asking local HCPs to perform study-specific research procedures or assessments that represent a direct and significant contribution to the clinical data for the study (e.g., assessing drug response for a patient or performing a procedure unique to the study and not part of routine medical care), these HCPs would be considered sub-investigators and should be listed on Form FDA 1572,” FDA writes in the guidance.

Further, shipping of infusion IP should be done from a central distribution site directly to the alternate infusion site and should be overseen and monitored by the investigator.  The investigator should be following established procedures that assures product chain of custody and IP quality during and upon delivery.

In thinking about the bigger picture, I am heartened and proud that in this challenging period in our country’s history, like others in the past, we are a nation of incredibly creative, adaptive, flexible and innovative people that are all working towards the same goal, to make our global society healthier.

Clinical trials are vital and need to continue functioning even during the most difficult times. Additionally, for sponsors looking to continue conducting clinical trials amidst COVID-19, this guidance clarifies the new solutions they may be exploring to support sites and ultimately deliver treatments to patients.

Peter “Pete” Tarasov is Senior Director of Quality Assurance and Regulatory Compliance for Greenphire – the global leader in financial software for clinical trials. He can be reached at Peter.Tarasov@greenphire.com.