Clinical Trials in 2020: A Year in Review
What has changed in 2020? How will 2021 shape up? Let’s evaluate.
2020 felt like a decade. So much change has happened in our lives, both personal and career wise, and we have forced ourselves to push the boundaries to implement novel clinical operational methodologies and technologies at breakneck speed. In February 2020, when I was
Pandemic shock
When most of the world shut down in Q1 2020,
When I shared
It was clear: the decentralized clinical trial (DCT) approach was the most viable solution to continue operating clinical trials during the pandemic.
Decentralization implementation is the new norm
Many biopharmaceutical sponsors and study sites, large and small,
However, some industry segments were successful in implementing DCTs, whereas others were not. Big Pharma was at a significant advantage; the
Quality refocus
As FDA warned in its guidance, clinical trial quality issues have likely arisen during the pandemic and have yet to be uncovered. Accordingly, clinical quality professionals have gone all hands-on deck to address clinical quality issues before they transpire into more significant problems. The biggest challenge during DCT implementation is that many sites have not had any experience with DCT approaches, and poorly designed DCT workflows have exposed study sites to compliance issues. Aside from the apparent remote site monitoring implementation, quality professionals focus on a solution that enables efficient virtual study quality assessments:
What will 2021 bring?
We will surely see a vaccine in 2021; nonetheless, experiencing a new “normal” will likely become a reality around 2024. Social distancing measures will still be in place for some time, governments will need to determine policies for vaccination validation, and COVID infection rates will need to be mostly eradicated before easing up COVID prevention measures. Additionally, people need time to get over the trauma of having dealt with a pandemic, and patients’ needs and expectations are changing drastically.
For clinical trials, 2021 will bring about a new norm for sponsors. Specifically, DCT approaches will likely be a part of every study’s design, and sponsors will have to deal with uncovering compliance issues and addressing them. 2020 has put us all through a journey; I’m optimistic 2021 will bring exciting opportunities for the clinical trials industry and the world as a whole.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.
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