Preparing For The Next Pandemic: Lessons Learned

Last year showed the impact of COVID-19 on how clinical trials are being conducted and the need to stay ahead of emerging viruses and infection diseases. This is a particularly opportune moment for introspection and reflection on the measures undertaken, to note achievements and failures, and perhaps to see what measures and approaches would most likely continue to be implemented after the pandemic. During 2020, Sponsors, CROs and other stakeholders were forced to shift to a remote working environment to alleviate disruptions and mitigate risks caused by the spread of the virus. Trial participants had to follow new public health recommendations. According to some accounts, enrollment into clinical studies was down nearly 70% in the early months of the pandemic. Decision making authorities around the world established new rules and put new processes in place regarding protocols that have allowed trials to continue: home visits, drug delivery and remote monitoring. The recent Food & Drug Administration guidance (published March 2020 and updated July 2020) acknowledged that the impact of COVID-19 may require companies conducting studies to consider virtual patient visits in order to increase patient diversity and retention rate in clinical research.

The New Clinical Development Paradigm