Innovating Clinical Trials: Real World Data in Drug Development

Randomized clinical trials are the gold standard for evaluating the efficacy and safety of medicines, but they come with many drawbacks including high monetary and time costs, a lack of representation compared to the general public, and ethical limitations. Historically, these trials were the main mechanism to understand the effects of a medicine. But more recently, real world data from sources such as electronic health records, insurance claims and billing activities, disease registries, and wearable devices, is having a greater effect on understanding a medicine’s usage and effects. Although this information is collected outside of clinical trials, clinical researchers incorporate it during the earliest phases of clinical development to gain additional information and speed up the drug development process.

In this episode, we talk to Brian Bradbury, vice president of the Center for Observational Research at Amgen, about the increased utilization of real world data and its potential to revolutionize every stage of clinical research, from trial design to regulatory requirements to outcomes measurement.

To dive further into this topic, please join Amgen scientists at the Innovating Clinical Trials Q&A webinar discussion on September 28, 2022. Register for the event here.

 

Welcome to Innovating Clinical Trials, a special edition podcast series produced by The Scientist’s Creative Services Team. This series is brought to you by Amgen, a pioneer in the science of using living cells to make biologic medicines. They helped invent the processes and tools that built the global biotech industry, and have since reached millions of patients suffering from serious illnesses around the world with their medicines.

Clinical trials are desperate for innovation. Speed and efficiency need to improve as many patients cannot wait over a decade for new, potentially lifesaving medicines, and trial participants often do not reflect the patient population. Because clinical trials are complex and multidisciplinary, there is not a single, simple solution for accelerating progress. In this series, Rob Lenz, senior vice president of Global Development at Amgen, explores the latest approaches in clinical trial design and execution and highlights real-world examples of how scientists can run trials better and faster to develop optimal medicines that benefit patients.