COVID-19 Implications for I-O Patient Management

Would be interested to hear discussion on what investigators and sponsors can do to support protocol endpoint preservation during this crisis.  Regulators have made statements of understanding about increased protocol deviations and encouraging telemedicine, etc. to minimize exposure.  However, I'm concerned that statistical impact and loss of population evaluability will have a dramatic impact on clinical trial analyses (both safety and efficacy), potentially requiring replacement of patients and protraction of trial timelines.  Certainly patient safety is paramount, but these things could ultimately delay trial outcomes and scientific progress. How do we mitigate?

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Jim Wise, MS
Exec Director - Head of IO, Cellular, and Gene Therapy
PRA Health Sciences
Charlottesville VA
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Hi Jim. I don't think there is a good answer here. Patient and provider safety in this case has to take precedence over ideal methods we use to assess clinical trial endpoints (CT scans, in person visits). I think sponsors of clinical trials need to think about how trials can be adapted to be able to assess key endpoints, while minimizing risks to patients and providers. Allowing remote visits for long-term follow-up visits, broadening windows for standard assessments etc will be useful. 


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Jarushka Naidoo MD
Assistant Professor
Johns Hopkins Sidney Kimmel Cancer Center
Baltimore MD
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Original Message:
Sent: 03-27-2020 08:16
From: Jim Wise
Subject: Clinical trial endpoint preservation during Covid-19

Would be interested to hear discussion on what investigators and sponsors can do to support protocol endpoint preservation during this crisis.  Regulators have made statements of understanding about increased protocol deviations and encouraging telemedicine, etc. to minimize exposure.  However, I'm concerned that statistical impact and loss of population evaluability will have a dramatic impact on clinical trial analyses (both safety and efficacy), potentially requiring replacement of patients and protraction of trial timelines.  Certainly patient safety is paramount, but these things could ultimately delay trial outcomes and scientific progress. How do we mitigate?

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Jim Wise, MS
Exec Director - Head of IO, Cellular, and Gene Therapy
PRA Health Sciences
Charlottesville VA
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