By Ed Miseta, Chief Editor, Clinical Leader
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As the COVID-19 virus continues to wreak havoc across the U.S. and the world, almost no segment of the economy has been spared its impact. That is certainly true of clinical trials conducted by the pharmaceutical industry.
As the near shutdown of cities and states continues, the task of carrying out trial visits, protocols, and data collection will border on the impossible. In an article recently shared on Clinical Leader, Laurie Halloran, CEO of Halloran Consulting Group, notes significant risks exist in trying to conduct trails in this environment. Missed data from patients being unable to travel to sites, delays in patient enrollment and study initiation activities, difficulty adhering to protocols, and delays in the distribution of clinical trial material are just a few of the concerns now facing sponsors.
The FDA is attempting to help sponsors navigate the challenges that now exist. The agency has recently released guidance on the conduct of clinical trials during the COVID-19 pandemic. From this guidance, it’s clear the regulator recognizes the need for sponsors to make modifications to the conduct of their trials, since business as usual is currently no longer the norm. With COVID-19 now reaching pandemic classification, trial changes will likely have to be made to accommodate the safety and needs of patients.
The FDA Makes Changes
In the guidance, FDA makes clear the safety and well-being of patients must be the primary concern of companies conducting trials. Sponsors must also consider whether their trials would maintain compliance with good clinical practice (GCP) and minimize the risks to trial integrity.
The guidance issued by FDA has certainly made it easier for trial sponsors to navigate the crisis. One of the more significant pieces of guidance relates to trial participants being unable to make scheduled visits to clinics. For those visits, FDA recommends sponsors evaluate whether in-person assessments are necessary. If so, alternatives to clinic visits should be considered. That could include visits to locations such as labs and imaging centers, and the possibility of home visits.
Sponsors may also want to consider making changes to trial protocols. For any changes deemed necessary, FDA recommends engaging with IRBs and IECs as early as possible. Changes should be consistent with the trial protocol to the extent possible and properly documented. If planned on-site visits are no longer possible, remote monitoring programs should be considered.
Despite the new guidance, the job of conducting trials in the midst of this pandemic is an extremely high degree of difficulty. And, as the pandemic and the shutdowns drag on, the difficulty in conducting trials will only increasing. Even if companies can add virtual elements to trials and incorporate more digital technologies to track patients, that doesn’t mean most sponsors can do so, or have the needed expertise to make it happen.
Changes In Inspections
The COVID-19 virus will also have an impact on regulatory interactions, inspections, and audits. Those are critical aspects of your trials that must not be overlooked. Halloran also shared advice on assessing how those elements will be impacted.
If you had face-to-face meetings scheduled with the FDA in March or April, be aware that those sessions will be converted to teleconferences. Halloran notes this method of connecting has advantages, such as being able to mute the call to conduct private discussions. Ultimately, though, sponsors should be prepared for some meetings to be cancelled or delayed.
In the coming months, global health authorities will be working in close partnership with industry to quickly progress therapies to combat COVID-19. President Trump has also asked the FDA to fast track these treatments to patients. But, while companies working on investigational agents for COVID-19 are receiving prompt and engaged responses from the FDA, delays in other areas should be expected.
For example, Halloran notes the industry should expect to see delays in pre-approval and other routine facility inspections. The crackdown on international airline travel and border closures makes that a certainty. Those inspection limitations will also extend to clinical and sponsor inspections. Virtual or correspondence-based inspections will be a likely outcome.
Inspections Go Virtual
According to Halloran, the FDA and other regulators will rely on virtual inspections and audits to protect trial participants, verify the accuracy and reliability of clinical data, and to assess study compliance. Sponsors should also not be surprised to have regulators request access to eTMF and other systems to assess trial conduct absent an in-person visit. She recommends sponsors prepare for virtual inspections with the same rigor and structure you would for an on-site inspection. Halloran also provides a valuable piece of advice: Consider conducting a virtual mock inspection to test your organization’s capabilities and preparedness during this crisis. You should also expect to see additional guidance released in the coming weeks.
Finally, be sure to consider the impact COVID-19 might have on your technology, architecture, and networks. Although technology seems like the last thing that might be impacted by COVID-19, some precautions should be taken. Companies should ensure technology such as hardware, access points, and support are available to employees. Videoconferencing capabilities should also be available to everyone, as well as interactive tools such as messaging apps, document sharing, and meeting platforms. While network outages are not expected, slowdowns may occur. Every company should also have a business continuity plan detailing how to operate in the event systems go down.
Until the crisis caused by COVID-19 begins to ease, sponsors should expect changes to their trials and operations. If instituting changes, don’t forget there are experts available to help. Consultants, technology providers, and CROs are available to lead you through these difficult times. Now, more than ever, sponsors need to know where to turn for the help they need. If you want to incorporate digital devices, hire healthcare professionals to visit patients in their homes, or evaluate your protocol to see what changes can be made. With professionals available to help you with those projects, now is a good time to reach out to them for guidance. The expertise is out there. Don’t hesitate to call on it.