The rate of change across today’s clinical research landscape is breathtaking, especially for an industry that has historically been considered slow to adopt. As we face a world-wide pandemic the likes of which we’ve never seen before, our industry plays a critical role in finding a solution. As such, new approaches are required – and the industry is responding. One obvious example is the use of telemedicine in clinical studies. Pharmaceutical sponsors and CROs are incorporating virtual elements into clinical studies at a greatly accelerated pace.
Virtual elements of decentralized clinical trials (DCT) can take many forms. Sponsors and CROs can use virtual pre-site technologies to evaluate, qualify, train and routinely monitor sites for studies to help alleviate travel restrictions. Similarly sites can use the same technology to ensure their inclusion in new study startups when they would have otherwise been inaccessible. And of course, virtual patient visits continue to be a crucial use case for telemedicine solutions.
A recent article in Clinical Leader pointed out that the expansion of telemedicine and virtual solutions is enabling us to meet our patients’ needs while also maintaining patient safety, study integrity, and data quality. In addition, the use of telemedicine helps conserve personal protective equipment (PPE) and safeguards the integrity of our healthcare system so it can serve those in acute need.
Telemedicine acceptability around the world
The adoption of technology in healthcare hit a sharp increase over the last several months as regions around the globe reacted to COVID-19. While there is increased attention in all regions, there is also a significant variance in adoption across geographies. Regulations surrounding virtual trials in the US, for example, have become more flexible over the last few months, but not all countries are seeing the same accommodations.
Australia is rather progessive as telemedicine has been widely adopted, even in clinical trials. It is supported by the government and covered by many private health insurance companies. Similarly, telemedicine in Europe is widely accepted and utilized and there is strong governmental support for e-health. There are some countries, however, that lack infrastructure such as Italy, Greece, Czech Republic, Austria and Ireland.
In North America, telemedicine is widely accepted and utilized within the U.S., although it is governed on a state-by-state basis. While some regulations have been loosened as a result of COVID-19, it is unclear if those changes will remain in effect long-term. Canada, however, has been slower to adopt, largely due to lack of funding and infrastructure.
Slow to adopt
In Africa the government is supportive but there are numerous infrastructure challenges including a lack of readily available Internet access and a shortage of physicians, healthcare facilities, equipment, medicines. Asian governments appear uncertain about the relative costs and benefits of supporting telemedicine on a broad scale and are also challenged with restrictive legislation and a patient preference to see physicians in person. South America has also been slow to adopt due to a lack of regulatory framework and financial barriers.
Coordinated industry efforts
Receptivity and scalability of telemedicine practices is likely to continue on a growth trajectory into the foreseeable future. While it will be some time before regulations across countries align, we expect to see continued efforts to simplify processes across regions within independent countries. In the meantime, sponsors, CROs, and sites are continuing to work together to forge ahead with the best options available for keeping studies on track. It is inspiring to watch our clinical research community rise to the occasion.