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The Rebound: Learnings from China’s Climb out of the COVID-19 Trenches

The novel coronavirus has swept across the globe, first hitting China and then Italy and Spain, leaving in its wake sickness, sadness, and loss. No industry has been spared the devastating financial, logistical, and personal impacts of COVID-19. Specifically, the life science industry has seen massive disruptions in clinical trial timelines and milestones due to the diverting of resources, spatial challenges, and overall de-prioritization of non-COVID-19 activities in healthcare settings.

As the U.S. outbreak marches toward its peak, our industry must continue to support frontline response efforts. However, it’s also imperative that we begin to plan for our transition out of the response phase and into the recovery phase so that we can get our therapies to patients in need as quickly as possible. Now that China has entered its recovery phase, it’s important to learn as much as possible from their experience – specifically, conducting clinical trials amid the COVID-19 pandemic so that we can apply any relevant tactics on home soil to optimize our outcomes and accelerate our path back to normalcy.

I recently had the opportunity to attend a DIA-organized panel discussion[i] in which Chinese industry experts shared learnings and considerations around business continuity plans (BCPs), operations, site management, and ethics committee activity. My takeaways are detailed below.

Business Continuity Plan (BCP) Considerations

BCPs provide guiding principles, detail ways of working, align disparate parties, and focus on critical data and processes. To be effective, BCPs must include crisis management plans to minimize the impact.

Operational Considerations

To make the soundest clinical conduct decisions, clinical operations professionals must prioritize patient interests but also triage the demands of sites/vendors, the protocol, and proper documentation and processing. Balancing these priorities is particularly important during a pandemic when on-site patient visits are often not feasible.

Patient safety is paramount, especially when treatment will occur outside the normal site. Investigators must thoroughly assess any local clinics, labs, and imaging centers that patients might visit for safety and efficacy.

Site Management Considerations

China saw a huge impact on site activity due to COVID-19 caused by strict entrance criteria for all personnel entering sites.

Ethics Committee (EC) Considerations 

As evidenced by Chinese clinical operations during COVID-19, ECs have considerable flexibility in the process, with minor adjustments having a major impact.

Knowledge-sharing is critical in the life science industry, and it’s even more paramount in the midst of such an unprecedented global struggle.  Multi-national, cross-industry and cross-functional collaboration will only serve to benefit all of us as we navigate these trying times.  It’s my sincere hope that this forced connectivity, innovation, and creativity will produce lasting efficiencies, and reinforce our collective courage to continue our fight against COVID-19.

[i] DIA WEBINAR: COVID-19: Experts from China Speak on Conducting Clinical Trials During the Pandemic