When the coronavirus pandemic reached the U.S., the FDA reacted swiftly to come up with quick solutions. In a few weeks, emergency testing was already in place, and that was an opportunity to convert some of the machines to be used as ventilators. The pandemic has paved the way for some new changes and trends, and they are going to have a significant impact on the medical industry. Here are five medical trends we could see very soon:
Approval Time is Going to be Faster
As the FDA’s emergency testing initiative is likely to expire, a backlog in approving medical devices is expected to occur due to the effects of COVID-19 as the clinical trial activities have been slowed down. Moreover, several sponsors diverted funds from clinical testing due to a significant declines in medical device sales. Several sites were also giving leave to their research personnel, leading to a sharp drop in clinical trials.
The FDA still needs to keep emergency measures in place for a period to address the backlog of issues, and this could see approval times getting shorter in the long term.
Acceptance of Remote Monitoring
Remote clinical research techniques are some of the methods that the FDA is proposing. It is considered as the preferable method since it will limit most movements during clinical studies. The FDA is also allowing some of the devices that measure body temperature and heart rate to be used remotely in the monitoring of patients, and allowing the use of these devices enables healthcare workers to access information about the patient’s vital signs. This remote monitoring has also become more comfortable due to the emergence of new enabling technology.
Use of Telemedicine for Clinical Trial Participants
Conducting meetings and evaluations is one of the protocols that were set by the FDA. Telemedicine is soon coming to the forefront in leading medical and healthcare visits. During this pandemic, virtual tools, and telemedicine are the best alternative method for site visits.
Furthermore, adding more information by sponsors will demonstrate that telemedicine is the appropriate tool for conducting clinical research.
Change to the Patients’ Recruitment Strategies
The use of social media platforms in recruiting, engaging, and retaining clinical trial participants is another factor that the FDA is encouraging at this time. It will reduce onsite visits, thus paving the way for telemedicine and home visits. The strategy will reduce the risk of virus transmission. Besides, as remote monitoring is becoming more common, so could remote recruitment strategies.
Conducting More Remote Auditing
More sponsors are resorting to using remote auditing for their clinical trial sites and internal teams. The use of Trial Master File Reviews, a remote auditing tool, is already becoming common. It is both time and cost-saving than in-person reviews. Its use may also expand as device manufactures are realizing the value and benefit of remote trial reviews. The remotely run “Practice FDA Inspection” is also useful for study teams who cannot conduct in-person exercises.
As the months roll by, these trends are likely to gather more momentum, and industry players like Genprex Inc. (NASDAQ: GNPX) may already in advanced stages of incorporating these into their operational manuals.
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