Leveraging Real-World Data Without Compromising Patient Privacy

The value of real-world data (RWD) and real-world evidence (RWE) in clinical trials is being increasingly recognized by researchers, payers, and other healthcare decision-makers. However, much of the current RWD sources contain personally identifiable information, greatly complicating access to these resources. In a new Clinical Leader article, learn more about complicated issues surrounding RWD and RWE and privacy and find out how the industry is moving forward.

According to Enno Behrendt and Liisa M. Eisenlohr, “The more applicable and practical the real-world data, the better the insights and options for informed decision-making and rapid advancement. However, therein lies a dilemma: innovators need personally identifiable information to most accurately aggregate and analyze data as well as to match patients in a synthetic control arm as closely as possible to the trial inclusion and exclusion criteria and study endpoints. Yet in many countries and regions, these details are strongly protected by data privacy laws. To solve this dilemma, innovators generally collect data with patient consent from participants in product or disease registries and other “opt-in” means, or they purchase anonymized data from other parties.”

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(Source: Clinical Leader, September 26^th, 2022)