The State of Cardiac Safety in Clinical Research - 2020&Beyond - a podcast by ERT

What have you seen and experienced in cardiac safety in 2019?

Cardiac safety is typically seen as a very stable area. However, in 2019, there was a lot of evolution as sponsors began to look for ways to reduce patient burden and find real-world cardiac evidence. Enter wearables: advancements in these convenient devices have made it possible to track patients’ health and the safety and efficacy of therapies at home, as in Stanford Medicine’s Apple Heart Study. This trend also reflects the shift toward home-based monitoring, which was reflected in the FDA’s new guidance on ABPM.

What do you anticipate happening in the industry in 2020 and beyond?

It’s become clear that passive health monitoring is the future of clinical trials. Technology will allow sponsors to collect data while the patient goes about their everyday lives, without requiring them to remember to wear or charge a device, even one they already use. Advancements in science and technology are making it possible to monitoring patient health at home in ways that are increasingly less intrusive, deviceless, and home-based. These developments will continue beyond 2020. In the next year, we also anticipate a huge shift toward virtual trials, and the evolution of wearables as they become less exploratory and instead primary and secondary endpoints in clinical trials.

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