Mitsu Rana

How has your clinical research been impacted by the pandemic, and what would you say your biggest achievements have been during this time?
COVID-19 disrupted clinical research, making it more difficult to collect and access patient data. Often, staff were unable to enter sites, and patients were unable or unwilling to travel to sites for fear of contracting the disease.

The pandemic changed how we work. While industry-wide, we were able to continue to meet with colleagues and clients regularly — albeit virtually — COVID-19 accelerated the acceptance and adoption of decentralised clinical trials and remote study management.

Data collection for trials is typically done in person, however, during the pandemic, we utilised a remote platform for trial sites to upload data that we could access simultaneously. This meant that data could be monitored across any time zone, giving us full 24-hour access and speeding up our timelines.

In the end, our goal was to keep trials on track and support our clients to develop COVID-19 vaccines and treatments. The spirit of collaboration throughout our organisation — and across the industry, to deliver an effective vaccine for COVID-19 — has provided me with the greatest sense of achievement.

What can the pharma industry do to keep pushing the boundaries of clinical research?
The key lesson my team learned this past year was to always consider new options and to not be inhibited by preconceived limits. Running studies during the pandemic required collaboration and strong communication between ICON, study sponsors and our sites. We identified our goals, looked at innovative ways to achieve them and made adjustments as needed — while always ensuring patient safety, maintaining data quality and regulatory compliance.

What does ‘innovation’ mean to you in an ever-evolving clinical research landscape?
To me, innovation means any type of progress we can make within clinical research, whether a baby step or a giant leap. It’s whatever gets us to the next level – taking an idea and making it actionable.

Innovation doesn’t always lead you in the direction you initially were expecting. But you can adjust and may end up learning lessons that you apply to other areas. For example, our progress on remote monitoring for vaccine trials and treatments came as incremental steps. But these lessons can help ensure that future clinical trials run faster and more efficiently.

How has ICON adapted its clinical trial services in response to COVID-19?
Beyond decentralised trials, we’ve increased our use of data analytics behind all our processes, using real-time data to inform how we move forward with different aspects of our trials.

We’ve enhanced how we recruit participants by using strategies to enrol those who will benefit most from treatments. We’ve increased recruitment on social media, offered in-home visits and mobile wearables for data gathering — all to encourage diverse participation.

Despite the challenges presented by the pandemic, the collaborative experience and innovative environment will enhance the future of clinical operations.