- Pandemic Impact: COVID-19 delayed 50% of clinical trials, forcing a transition toward virtual and decentralized models.
- Regulatory Support: The FDA and other bodies now provide clear guidance on remote consent and home-based medication delivery.
- Expanded Reach: Virtual trials remove geographical barriers, allowing for recruitment from a wider radius and more diverse populations.
- Operational Continuity: Digital infrastructure ensures research can continue during lockdowns or future global disruptions.
How the pandemic changed clinical trial conduct
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 substantial 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. The case for virtual trial infrastructure is now well-supported by both regulatory guidance and operational evidence from trials conducted during the pandemic.
How virtual models kept trials running during lockdowns
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 epicenters 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.
With the help of 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.
How regulatory guidance enabled remote trial participation
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.
The FDA recommendations for virtual trials include:
- Switching to telephone or video check-ins.
- Direct-to-patient medication delivery (for self-administered treatments).
- Electronic methods for obtaining remote patient consent.
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 virtual recruitment
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 beyond a hospital or doctor's office means that the study can attract more participants. This, in partnership with virtual participation, means a broader candidate pool, including populations that have historically been underrepresented in clinical research.
Digital recruitment strategies, including social media outreach, allow trial teams to reach broader and more diverse participant communities, including those with specific medical conditions who may not be connected to a nearby research facility. 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 in the post-COVID era
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 virtualization has allowed clinical trials to resume and even begin during the lockdowns over the past two years.
With 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 beyond the pandemic. As trials resume, the operational and regulatory lessons learned during this period can be applied to build more resilient and inclusive trial infrastructure. The learnings and advancements from this crisis can be implemented to create a more successful process for clinical trials in the future. Sponsors who can integrate elements from decentralized or virtual trials will be better prepared for healthcare emergencies or systemic disruptions.