COVID-19 Implications for I-O Patient Management

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This discussion board is devoted to conversations directly relevant to clinical care. Example topics include:
• Trends in demographics
• Trends in clinical presentation
• Issues regarding diagnostic testing
• Patient management issues/insights
• Observations on emerging natural history/patterns in clinical complications
• Difficult cases
  • 1.  Clinical trial endpoint preservation during Covid-19

    Posted 03-27-2020 08:17
    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?

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

  • 2.  RE: Clinical trial endpoint preservation during Covid-19

    Posted 04-15-2020 13:20
    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. 

    Jarushka Naidoo MD
    Assistant Professor
    Johns Hopkins Sidney Kimmel Cancer Center
    Baltimore MD