Holmusk representatives contribute to Duke-Margolis Real-World Evidence Collaborative white paper on improving patient subgroup representation using real-world data

November 7, 2023

In December 2022, representatives from Holmusk participated in a private, virtual convening hosted by the Duke-Margolis Real-World Evidence Collaborative, along with other industry representatives, research groups, sponsors, patient advocacy groups, and data vendors. These efforts informed the publication of a white paper by the Duke-Margolis Center for Health Policy entitled Improving Patient Subgroup Representation with Real-World Data – Real World Efficacy and Patient Subgroups.

Evidence generated from real-world data (RWD), or data generated outside of traditional clinical trial settings, has the potential to be broadly applicable to subgroups of patients who are often excluded or disengaged from clinical trials. Studies using RWD can enable inclusion of traditionally underrepresented subgroups; leveraging EHR-derived data collected in routine care settings presents fewer barriers to research participation than conducting randomized controlled trials (RCTs).

Studies that incorporate RWD enable the investigation and measurement of on-label or off-label treatment effects and safety outcomes in patient subgroups. Importantly, variations in treatment effect across patient subgroups may warrant tailored clinical approaches to treat and clinically manage these patients in real-world settings.

In this white paper, opportunities and challenges associated with using real-world data to estimate and measure treatment effects among and across patient subgroups are discussed.

In addition, the authors discuss:

  • terminology uses and considerations that accompany measures of therapeutic effect in real-world versus clinical trial settings
  • supplementing clinical trials with RWD for subgroup analysis
  • leveraging RWD to address data missingness
  • improving care among patient subgroups

“It is exciting to see how real-world evidence can be used to complement the findings from RCTs for many use cases, such as identifying which factors may be important to consider when selecting the most effective treatments.” - Maithri Vangala, Senior Director - RWE Strategy and Operations, Holmusk and Duke-Margolis Real-World Evidence Collaborative participant

To read the white paper, click here.

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