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Healing from a Pandemic and Building Resilience into Future Clinical Trials

Lessons Learned from a Virtual Town Hall held on June 5, 2020

Halloran’s ninth town hall focused on how sponsors are looking beyond the pandemic to design and plan resilient clinical trials with the ability to withstand future pandemics and mitigate some of the key challenges experienced. Some of these challenges include the inability to treat patients, access to investigational products, missed patient visits and limited data collection. COVID-19 has forced our industry to do to critically examine and make decisions on what specific data we really need to assess the safety and efficacy of products. We must now rethink our design strategies and planning processes before starting studies to find the right ‘fit-for-purpose’ virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.

In previous town halls, sponsors have thoroughly discussed both reactive and proactive responses to the pandemic – whether it is switching to remote visits, investing in centralized monitoring platforms, investigating home healthcare options or simply taking a more patient-centric approach to study design. But what has truly changed, in the short-term, is that studies need to start because patients need to be treated and drug development cannot cease altogether. There is little doubt that the pandemic has significantly affected how studies are conducted, but are we seeing new studies now being designed and planned drastically different than those prior to the pandemic?

With 62% of the town hall attendees indicating that they have made changes to their documented processes (due to the pandemic), Halloran focused on understanding exactly what those changes are.

Considerations When Starting a New Trial

Flexibility is the driving force for developing new studies. From decreasing patient burden to diversifying sites to enforcing more rigorous risk management processes, sponsors have creatively enhanced their current processes versus completely re-engineering standard operating procedures (SOPs) that would require significant resource investment. These nimble changes lay the groundwork for future and widespread process changes, when necessary.

Site Selection

Protocol Flexibility and Simplify Study Design

Plan Development, Process Changes, and Committee Development

Barriers to Conducting Decentralized Trials

Sponsors have not seen significant barriers to utilizing decentralized methods and are taking advantage of the current circumstances, as an opportunity to accelerate acceptance of decentralized/virtual trials. However, there are some obstacles preventing complete adoption – these include the following:

Engaging in Multidisciplinary Teamwork

Site Engagement


COVID-19 has presented challenges across our industry. We can take lessons learned from this difficult situation and use them to improve trial design and planning by adopting a risk-based approach and utilizing our available resources effectively. For years, FDA guidance has encouraged us take advantage of decentralized trials (finally!). COVID-19 has helped us to accelerate into the future but remember success in this new paradigm is only possible with the right upfront design and planning processes. So take the time to do it right!

Please reach out to us if we can help in any way or would like to be included in any of our upcoming town halls.


Laurie Halloran, CEO |
Paola Murphy, Chief Client Officer |
Katie McCarthy, Chief Development Officer |
Sheila Gwizdak, VP, Quality |
Kim Raymer, VP, Regulatory Affairs |
Jason Milovanovic, VP, Clinical Development |