In this blog we explore the impact of the COVID-19 pandemic on clinical trials, how organisation have been rethinking current approaches, and what the future of virtual clinical trials could look like.
Momentum for virtual clinical trials has been gradually building for years, but progress has been hampered by a lack of clear guidance from regulators and a reluctance to invest in the technology needed. However, since the emergence of COVID-19, there has been massive disruption to medical research; 50% of pre-COVID-19 trials have been delayed due to patient recruitment, forcing researchers and CMOs to rethink current methods through which trials are conducted.
These large scale delays have been further extended by the fact that COVID-19-focused research has had to take priority. As the UK faced its second national lockdown, pressure continued to mount to expand coronavirus research, as well as resume pre-COVID trials. So, is now the perfect time to adopt a virtual structure for clinical trials? It certainly seems like it.
Fifty percent of pre-COVID-19 trials have been delayed due to patient recruitment.
With many pre-COVID trials paused, delayed and even cancelled, and with a complete shift to Coronavirus-focused studies, it's been a difficult and uncertain period for medical research. Hospitals formed the epicentres of COVID-19 outbreaks around the world, which led to an overwhelmingly large portion of clinical trial participants becoming reluctant to attend routine check-ups and monitoring.
This, partnered with the fact that many healthcare workers have been redirected towards the frontline in battling the virus, means that in many cases, in-person clinical trials simply aren't feasible.
This virtual setup means that participants can be recruited within a wider radius.
Enter technology: a handful of clinical trials around the globe managed to resume or begin, with the help of online or telephone check-ins and the option to deliver medication straight to participant's homes.
This virtual setup means that participants can be recruited within a wider radius and not just confined to a small location near a hospital or medical research facility. It also means that clinical trials can continue through lockdowns, national or otherwise, while at the same time reducing the risk of coronavirus spread for both participants and healthcare workers.
In March 2020, the US Food and Drug Administration (FDA) issued guidance on protecting patient safety during the COVID-19 pandemic. This guidance featured information about new virtual methods which can be adopted in lieu of in-person visits.
These recommendations include switching to telephone check-ins and sending medication straight to a participant’s home (as long as it can be self-administered). Along with the changes in protocol and the added safety measures, the FDA has also followed the UK in supplying advice and permission for gaining consent for clinical trial participation remotely. Ongoing trials are using these electronic methods and have already been able to obtain patient consent more easily.
This new guidance has paved the way for clinical trials to be conducted at a distance, which will allow studies to expand across a larger geographical range and continue during the pandemic without compromising patient safety.
A shift to virtualisation has allowed clinical trials to resume and even begin within a lockdown environment.
The funnel that takes potential candidates through to study completion has expanded. Now, patients and participants can sign up online or even discover new clinical study opportunities through social media.
Opening recruitment up beyond a hospital or doctors surgery means that the study can attract more participants. This, in partnership with virtual participation, means a massive increase in potential candidates for trials and access to candidates who are often highly underrepresented in research.
For example, Sano Genetics uses social media and content marketing to engage with an online community at scale. This creates better access to a wider, highly engaged audience - including those with specific medical conditions. In addition to this, the use of social media as a tool for recruitment also ensures that researchers can reach out to minorities, which is ever more important as COVID-19 has affected these populations disproportionately.
Clinical trials are an essential tool in medical research, but COVID-19 has exposed ways in which their design, conduct and reporting could be improved. A shift to virtualisation has allowed clinical trials to resume and even begin during the lockdowns over the past two years.
But with no definitive end to this pandemic insight, and the potential for other similar catastrophes to disrupt medical research in the future, it's important to have methods and infrastructure set up for trials to continue virtually in the post-COVID-era. Gradually, clinical trials will resume in the new-normal and the learnings and advancements from this crisis can be implemented to create a more successful process for clinical trials in the future. So, if there ever was a 'right' time to start thinking about taking your clinical trial online, it's now.