The Limited Future of Real-World Data

May 12, 2022

Michael J. Howley, PA-C, MBA, PhD Peter Malamis, MBA

Survey among pharma and CRO executives evaluates current usage of RWD.

Real-world data is enjoying prominence after how well it performed during the COVID-19 pandemic. The market for real-world data is now expected to grow at 14.4% annually (MarketsandMarkets, 2022). At the same time, however, buying, curating, and protecting real-world data is becoming increasingly expensive.

Are the benefits of real-world data worth the cost?

As a first step to researching this question, we surveyed 133 pharma and CRO executives to see how real-world data is currently being used. Here is how these executives rated their current usage across functions.

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Three points stand out to us about these findings:

  • Current usage averaged across all functions is a Themediocre 5.8 on a scale of 1 to 10. Executives we spoke to about these results agreed. Real-world has a role in clinical trials, but it will not replace randomized control trials.
  • There was a narrow range of usage ratings. Real-world data may have mediocre usage, but it is used broadly within organizations when adopted. Our executives described a situation where data is getting so expensive that it is becoming centralized with all functions encouraged to use for their particular purpose. There is also a ‘cool factor’ with using these data.
  • Real world data has low usage in its principle function—FDA submission for approval. It has higher usage in supporting functions. This may get better when the FDA finalizes their guidance and companies figure out how to meet those expectations.

We also heard about the challenges involved with using real-world data. It is not just the expense of acquiring the data. You have to wrap the data with an ecosystem that allows access to the different functions and protects the data.

To assess the future uptake of real-world data, we then asked our respondents to assess their anticipated future usage of real-world data.

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The significant findings from this analysis were:

  • There was a greater spread of usage across functions, indicating a varied usage of real-world data across functions. These data may be cool right now, but over time we will see where it works best.
  • Future usage was higher in all functions, but the average was only 0.6 higher usage on a scale of 1 to 10.
  • FDA submission was ranked second-from-the-bottom, confirming our discussion above.

The difference between current and future usage illuminates the growth potential. Across all functions, there was a 0.6 increase in anticipated usage, on a scale of 1 to 10. There was anticipated usage increases across all functions, but we were surprised at how modest the gains were.

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None of the functions saw an increase of usage greater than 1 point—about 10%. FDA submission did show a lot of potential for growth, but there are still more supportive function ahead of it.

We were surprised by the modest enthusiasm for real-world data usage and anticipated growth seen in our data. But remember that we approached the question from a granular level—the specific functionality of real-world data. If we had asked a more generic question about the future of real-world data, we suspect we would have received more positive responses.

This modest enthusiasm also overlooks the ability real-world data to diffuse throughout organizations. So while real-world data may have limited depth across the industry, we find there is breadth of use across the functions.

What does our data say about how we can enhance the uptake of real-world data? That is the topic for an upcoming blog.

Michael Howley PA-C, MBA, PhD, and Peter Malamis MBA

The authors of this blog thank the many executives who reviewed these findings, including the Pharmaceutical Executive Roundtable participants on March 10, 2022.

Reference

  1. MarketsandMarkets. (2022). Real World Evidence/RWE Solutions Market by Component (Dataset (Claims, Clinical, Pharmacy, Patient), Services), Therapeutic Area (Oncology, Cardiovascular, Neurology), End User (Pharma, Medtech, Payers, Providers) Covid-19 Impact – Global Forecast to 2026. Retrieved from https://www.marketsandmarkets.com/Market-Reports/real-world-evidence-solution-market-76173991.html

Source: https://www.appliedclinicaltrialsonline.com/view/the-limited-future-of-real-world-data