It’s difficult to say if the clinical research world will return to “normal” once sites have opened their doors to patients, monitors and sponsors again.
Given the circumstances of these unprecedented times, there are bound to be challenges sites will face when the dust settles. However, there may also be new opportunities and alternative ways of conducting study procedures that were once thought to be the “standard”.
Like a rush of water from a burst dam, when sites re-open there may be an influx of monitors and sponsors reaching out to schedule a meeting or time to monitor study data, especially if a remote conversation or monitoring visit was not feasible during the pandemic restrictions. The sites will be faced with many different personnel from many different studies all trying to communicate at once, and it can be overwhelming, to say the least.
“From a site perspective, this is a crazy time. Half our business has been put on hold, yet our workload is increasing. We are being inundated with phone calls, e-mails, and requests for updates from every sponsor client. We are dealing with 230 concurrent trials and all have unique requests. I have even spoken with several sponsors that are still demanding on-site visits take place. This is very disruptive. Sites are hurting financially and, suddenly, most of their work is unpaid activities.” Jeff Kingsley, founder and CEO of IACT Health explained during a live online discussion on the COVID-19 pandemic and the impact it will have on clinical trials.
Additionally, sites may even be removing staff members to compensate for the decreased workload during the pandemic; however, as soon as sites re-open and on-site monitoring visits begin to resume, it can have a negative impact on the staff that remain assigned to clinical studies. It may also lead to the hiring of inexperienced research coordinators and a decrease in time spent on protocol training to bring site personnel up to speed.
Finally, with new safety precautions being presented to patients every day and the potential for virtual follow-up visits, sites may see a decline in subject compliance with protocol requirements/follow-up visits.
Outside support can go a long way, whether this is from the monitors, sponsors or both. Extending a helping hand and focusing on key items while accelerating a clinical trial back up to speed can help ease the burden and pressure sites may feel to get every item checked off their list. “Try to put yourself in their shoes…” Rosalie Filling, VP of R&D operations at Endo Pharmaceuticals noted during the same live online discussion noted above.
While there may be some unexpected challenges, there may also be new opportunities for both sites and sponsors when the pandemic restrictions fade. It’s easy for sponsors and monitors to stay in their comfort zone; however, this is a wonderful opportunity for everyone involved to think outside the box.
Many sponsors might be looking at how remote monitoring was conducted during the pandemic, and if this could open a door to remote monitoring as a more permanent solution for monitors, rather than traditional on-site visits which tend to be more expensive.
As noted in the FDA Guidance, there has also been discussion of investigational product being shipped directly to patients at their home, by either a route from a clinical site to the patient location or a route from a distribution depot to the patient location. The FDA states that requirements under FDA regulations for maintaining required investigational product storage conditions and accountability remain, and these requirements must be addressed and documented. Eliminating the need for patients to visit the clinical research site can lead to a more streamlined process for patients to receive investigational product.
At-home assessments and protocol required follow-up visits are also being pursued. This method of collecting study data could allow the site personnel to conduct assessments in combination with dispensing any applicable investigational product to the patient in the comfort of their home. Site personnel could travel to patient’s home or conduct follow-up visits virtually.
“The silver lining is that we will be much better at doing [clinical research] in the future,” says Kingsley. “The pain we are currently experiencing will accelerate the adoption of new technologies and new ways of conducting clinical research. It will change how we design protocols and how we look at contracting and budgeting. The future looks very exciting. We just have to survive today.”
If you have any insight as to potential challenges or new opportunities that may be presented when the pandemic begins to fade, please share below.