Following the realization of the COVID-19 outbreak, the FDA has taken measures to establish new medical device clinical trial guidelines that take into account the pandemic’s impact on previous clinical trial practices. Reflecting on that guidance and addressing the principles of patient safety, compliance with good clinical practice, and minimizing risks to trial integrity, we see four pillars as the core strategies essential for enabling the continuation of the clinical trial landscape.
Here in Part two of this three-part blog series, I discuss strategies underlying the four pillars that drive the continuation of clinical trials, and key essential steps that keep the trials going despite all the barriers of COVID globally.
Pillar 1: Patient Visit Enablement Services
It’s important to have flexibility within the COVID-19 pandemic era. If patients can physically get to a trial site, ideally that would be great, but that’s very difficult during this time period. So, it’s critical to establish means to allow sites to remotely talk to their patients and to get adequate investigational medicinal product (IMP) to the patient in their home or to an adjacent facility. For example, in an oncology trial, it’s essential to perform infusion of an immunotherapy, if necessary, somewhere isolated where there are no COVID patients in proximity that would compromise the patient. Another example could be having a home health nurse come to the patient to perform the infusion, having the phlebotomist come and take laboratory specimens, and having a local lab process them.
Pillar 2: Logistics and Supply Management
Second, it’s important to establish and easily be able to tap into revised logistics and supply management processes. It is mandatory to put in place a logistics management network that can ensure IMPs can be delivered and that labs can be taken. When picked up at the trial site, the transport service must be able to maneuver around road closures, flight delays or cancellations, and other hurdles that can impede expediting the delivery of those labs and materials for processing.
Pillar 3: Remote Site Monitoring and Data Review
I described this focus area in Part one of this series, indicating that it is critically-important to immediately spin into a remote data monitoring approach. This allows for quickly moving into monitoring and retaining subjects in a trial so that the clinical research associates (CRAs) can monitor those subjects with the site staff.
It’s necessary to work with the study coordinators and investigators, and to do whatever is required to support site staff who are likely overwhelmed with all the activities taking place at the healthcare site, whether it is a hospital or a commercial investigative site. With all the demands on their time and focus, it is essential that they have support to retain patients in the clinical study.
Pillar 4: Site Support Services
Certainly the current need is on bolstering investigator sites with training and supporting the virtual trial-type activities, but it is also advisable to prepare to return to on-premise processes when sites start to open up. It may be necessary to supply them with additional clinical research coordinators (CRCs) or technical support that helps with the backup of workload and, where needed, ensures secure data transfer, without privacy concerns, of some of the source materials.
Ongoing Regulatory Support
And then, of course, it is always critical to provide regulatory support. Protocol amendments often need to allow for remote monitoring, direct to patient shipment, changes in screening and enrollment, and virtual trial visit modalities. These amendments will be required at the project and country level so the sponsor and sites will need support in executing this process quickly. It may be that some countries and locations need this and others do not, given the prevalence of COVID in one area versus another as well. These conditions and modifications could persist through recovery, so it may continue through the close of the trials. Taking a multi-faceted regulatory approach supporting your project teams enables solutions to unfold in a proactive manner.
Each of these pillars is important to clinical trial studies in flight right now and for studies nearly ready to begin, as well as those in your clinical development pipeline that will be coming in the near future. As sites begin to open up, there will be a delay in patients who may want to join trials. To address this concern and to encourage patients to return, it is advisable to consider multiple arms, such as direct-to-patient and other approaches to executing trials, that would afford myriad options for patients and for sites, enabling strong clinical trial involvement.