Finding the Light in a Dark Situation: Lessons Learned from the COVID Crisis
This blog was authored by Fiona Maini, Global Compliance and Strategy Principal, Medidata.
The last 20 months have been like no other, with all of us having our lives affected by COVID to some degree. Thanks to the roll out of vaccines, we can now see some optimism surrounding the virus, but the impact of the pandemic is yet to be fully measured, with some forecasts predicting long-term societal and financial consequences for many countries. While there has been a tragic loss of life and impact on quality of life over the past 20 months, there are some positives that will emerge from the pandemic.
COVID-19: A Catalyst for Change
Reflecting on the past 20 months, we have seen strength through adversity across all industries and indeed all of society. What’s more, although COVID-19 has been a significant humanitarian crisis, it has also been a catalyst for innovation and the widespread adoption of current technologies. Our industry in particular was quick to react, adjusting to new models which use remote strategies to allow existing trials to continue and new trials to start despite restrictions and social distancing measures. Without this rapid response and willingness to adapt to an ever-changing situation, new treatments such as the vaccines we have relied upon could still be in development now.
An Industry-Wide Response
To describe how the clinical trial industry responded in a few words: collaboration, community, resilience, and innovation. For those working in the industry, their key roles in developing new vaccines, therapeutics, and diagnostics held the greatest prominence and urgency, which brought about unprecedented collaboration between regulators, academia, and competitors to help unravel this crisis. These partnerships revolutionised the way that medicines and products could be developed in the future; hopefully what we’ve seen during the pandemic leads to a greater commitment to human health across the board.
In terms of community, we've seen armies of frontline workers and volunteers across the world rising to the challenges of the pandemic. These individuals have directly placed themselves in clear danger, while resilience has enabled individuals, communities, organisations, and countries to cope with the stresses and pain of the pandemic.
Looking at innovation, human inventiveness knows no bounds when confronted with significant challenges and the COVID crisis was no different. We've seen people find new ways to do things and leverage new technologies to help us continue to work and develop new treatments despite the constraints of lockdowns and social distancing.
Decentralized Clinical Trials: the New Normal Post-COVID
Regulators also reacted very quickly to the pandemic, introducing lots of flexibilities and remote strategies, such as decentralized clinical trials (DCTs). The pandemic exposed the urgent need for clinical trials driven by next-generation technologies, and these will continue to evolve over the coming years. Decentralized clinical trials are not a new thing, but they became increasingly prevalent during the pandemic and will become even more common as part of the new normal beyond COVID-19.
The remote monitoring capabilities of virtual trials give participants greater flexibility, helping them to fit trial participation around their daily lives. Participants also have peace of mind that they won’t be exposed to unnecessary risks at trial sites, which has obviously been hugely important during the pandemic. Virtual participation also allows for greater diversity and the inclusion of larger populations, as well as enhancing patient recruitment, engagement, and retention. Clearly, a fully decentralized model is not suitable for all trials, but a hybrid option can work in many cases. Going forward, the industry will be more willing and able to explore all of the options available outside of the traditional clinical development model.
While the past 20 months have been challenging for us all in numerous ways, we should not overlook the positives that have emerged from the crisis. As we continue forward, it will be vital that we don’t forget all of the lessons learned, relationships formed, and technological innovations developed—all of which will serve to make our industry and society stronger and more prepared for any future crisis.