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Clinical Trial Conduct During COVID-19: Developing a Proactive Strategy Under Reactive Circumstances

Lessons Learned from a Virtual Town Hall held on April 24, 2020

As the COVID-19 pandemic continues to evolve, conversations around reopening strategies and business continuity have become increasingly important. Sponsors and sites have been executing contingency plans to minimize delays, protect data integrity, limit attrition, and ease site burden; yet, the challenge continues to be reacting quickly enough to keep up with a situation that changes by the hour. It’s becoming clear that we need proactive, collaborative planning and execution to mitigate the impact we’ll absorb when the pandemic loosens its grip on our industry, along with a significant effort to advance our virtual capabilities forward.

Halloran’s 6th Town Hall focused on proactively planning different scenarios for our new “normal”. Topics included, but were not limited to:

The open forum gave both sponsors and sites a voice in the conversation, allowing them an opportunity to communicate their needs, learnings, and challenges to an audience eager to learn from their perspectives and contribute themselves.

Stats and data

As we transition out of this pandemic and into our new “normal”, it’s important to seek input from biostatisticians on the coronavirus’s impact.  For example, failing to capture data from patients in clinical trials has become a common occurrence due to the hindrance caused by COVID-related mandates that limit patient access to sites. Statisticians, clinical teams, vendors, and sites need to collaborate to assess the magnitude of impact on the patient level while continuously prioritizing patient safety.

Additionally, stakeholders must build mitigations and rationale around any missing data and at-risk endpoints.

When thinking about your statistics strategy for missing data, remember to 1) collect what you can, 2) document what happened, and 3) analyze.

1) Collect what you can

2) Document what happened

3) Analyze

A quality expert’s advice to sponsors when planning for a post-COVID19 world

What sites need from sponsors

What sponsors need from sites

What patients need to feel comfortable participating in trials

To escape our current cycle of reactivity and set a new standard of proactivity, it’s critical to share information and knowledge beyond our industry silos. Increased collaboration and communication between sites and sponsors will only serve to bolster our collective ability to plan ahead, anticipate, and execute in a way that will reduce the impact on our patients.

Importantly, this is an opportunity for us to come together and establish new norms that will equip us with the agility necessary to deliver therapies to patients effectively and efficiently even under circumstances that are outside the norm.

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.