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28min

An Exciting Time for Real World Data with Michelle Hoiseth of Parexel


Summary

During this episode of Real World Talk, host Zoe Li has a conversation with Michelle Hoiseth, the Chief Data Officer of Parexel. Michelle talks about this being an exciting time for real world data and the opportunity that exists for the life sciences industry.

Highlights

  • Michelle Hoiseth opens up the conversation by stating how she feels like, with real world data in clinical development, we’re in an incredibly exciting time for change that we haven’t really seen for 15 years.
  • Michelle mentions how real world data has the opportunity to play a critical role in the clinical development continuum.
  • According to Michelle, real world data is “showing up” in many places throughout the cycle, including up front in a clinical trial, during design, as a source of patient level data, during changes in the regulatory environment and in the prescribing environment.
  • Leveraging the experience of groups like epidemiology, and health economics – that have had more experience with data in the clinical development end of the spectrum – is key to gaining more traction with real world data.
  • Michelle covers some of the barriers to the adoption of RWD in clinical development and regulated uses. 
  • In the COVID environment, Michelle talks about how the industry has a lot of tolerance now to try new methods and it’s forcing the industry to figure things out – like plumbing, traceability matrices and data lineage.
  • Michelle talks about one of the positive results of organizing as a society around COVID includes changes on the healthcare provider side around data. 
  • Michelle mentions that for a long time, there was opacity in the data. This included a lot of variability and insufficient access to data. Technologies are now catching up and it’s really changing the industry.
  • Michelle mentions that protocol design is often the very first point of failure.
  • Michelle discusses the key steps, as a drug developer, that must take place in order to rethink the planning of protocol design.
  • Michelle discusses whether the current ecosystem is set up for using more real world data in clinical development.
  • For CROs, many are exposed to study execution across a broader number of studies in a certain therapy area…but are not always brought in during the design stage. This means that a CRO’s ability to spark discussion isn’t always soon enough.
  • Michelle talks about how, “we as patients and the loved ones of patients”, want the safest and most efficacious therapies available. And, this ultimately all comes down to trust.
  • So much of trust is about transparency and that’s why Michelle believes the life science industry must operate differently. Most of the time, there’s a lack of transparency because there’s a concern about intellectual property.
  • Michelle highlights that no single organization is going to pierce through all of these data challenges and that it’s important to come together as an industry.

Key Points

  • According to Michelle, there are a number of barriers that have prevented the adoption of RWD, “There have been a number of barriers to the adoption of RWD in clinical development and regulated uses. And they have spanned from things like cost and budget to uncertainty about the reliability of the data to risk aversion coming from uncertainty of the regulatory acceptance of that as a data source. It has really spanned an array of issues.”
  • Michelle states that “Being data agnostic matters, being clear about how you’re going to use the data matters.”
  • When asked whether the industry can collaborate better to bring in real world data, Michelle stated “It’s a big heavy yes, because it’s such a complex environment as we’re, thinking about all the different players and in the way that we interact…the points of interaction today in our standard way of working. And it’s complex in that we have a number of different industry initiatives going on around real world data that aren’t necessarily coordinated or talking together. “
  • Michelle pointed out that, “…as we move into leveraging new sources of data, it’s on us to be able to look any patient in the eye and say, ‘We’ve done the best job we can here. We stand behind this result and the analysis, and that’s us all coming to the table together.’”

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