Covid-19: Considerations for Clinical Outcome Assessments in Clinical Trials

June 1, 2020

Cogstate senior scientists came together (digitally) from three continents to discuss clinical outcome assessments in the COVID-19 era. We invite you to watch the video of their roundtable discussion.

Virtual Roundtable Summary

COVID-19 is leading study teams worldwide to reconsider and adapt the methods by which they administer clinical outcome assessments (COAs). In speaking with many sponsors dealing with the myriad of new data collection complexities for clinical trials of CNS disorders, we’ve consistently heard similar questions, including:

  • What are the FDA guidelines around COVID-19 adjustments?
  • What are the consequences of not conducting assessments and having missing data?
  • How do we stay aligned with IRBs, scale authors, and regulators?
  • What adaptation options are there for Cogstate computerized tests?

Three of our senior scientists—Prof. Paul Maruff, Dr. Chris Edgar, and Dr. Pam Ventola—hosted an informal roundtable on the issues that have been the topic of so many meetings with our customers and collaborators. In the video roundtable, they share insights and give general guidance regarding modified delivery of COA administration.

As you consider the impact of these issues on ongoing and upcoming clinical trials, we encourage you to reach out to our team. Each trial is unique, and we are eager to partner in developing tailored and timely solutions to address the issues that will help keep your research efforts on track.

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