Increase Patient Safety: Quality Clinical Trial Data

Do deep analysis to ensure quality clinical trial data

Nancy Isaac joined us for the June 2014 panel discussion of ‘Leveraging Real-Time Reviews: Quality Clinical Trial Data’.

In an industry where clinical trial protocols are becoming more complex, it is more critical than ever to leverage real-time reviews of clinical outcome data. Our panel of clinical trial experts shared their specific experiences, challenges, and insights on obtaining and managing quality clinical trial data.

Nancy Isaac, VP Regulatory Compliance and Quality at NeoTract presented to the ClinOps Toolkit Bay Area meetup and networking group June 2014.  Her message was clear, we can increase patient safety through data vigilance.

Not the Magic 8-Ball Approach

Do deep analysis to look for trends and patterns.

You can’t rely on a magic 8 ball to let you know if your drug is working yes or no.

  • Why did some subjects respond and others did not?
  • Did the responding subjects all follow the same clinical course?

Nancy explains that as far as safety, we need to be able to look at the data in multiple dimensions and look for patterns. The most important thing is to look for patterns to mitigate risk and spot trends early (good or bad). So determine what is really happening and whether this product can be approved for the market.

What is the Cost of Quality Clinical Trial Data

“Clinical trials are very expensive” states Nancy “but there is only one thing more expensive that good data, and it is bad data.”

About The Author


Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

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