How to conduct a Phase III program in a pandemic

Kathleen Rickard, chief medical officer, Verona Pharma, provides an Expert View to educate other executives who are considering going down the remote/flexible route for clincial trials.

Therapeutic development is based on a comprehensive benefit-risk assessment to develop new medications for patients. Conducting a global Phase III respiratory program can be a challenging task for larger pharmaceutical companies, let alone a small biotechnology company. In addition, the complexities of a global pandemic and a vulnerable patient population could make beginning a global Phase III program a daunting activity for any company to undertake.

As we prepared to launch the Phase III trials, the pandemic struck and while grappling with this new normal, we needed to adapt our initial plans. We had to consider how to ensure safety of trial subjects and staff, and provide operational flexibility within our Phase III program to mitigate the risk of COVID-19. Our specialized clinical team based in Raleigh, North Carolina, drew on their past experience of navigating challenges to clinical trials including volcanic eruptions, riots and other disease outbreaks such as SARS and Zika to anticipate and build workarounds for COVID-19.