In evidence-based clinical trials, the success of a trial is based on measurable clinical outcomes known as endpoints. For example, measuring blood markers as surrogate endpoints for diabetes. Typically, endpoints have focused on traditional types of measurements usually taken in a hospital setting such as measuring biomarkers, cell counts or ECG.
However, new health technologies are opening up opportunities for other types of clinical endpoints such as novel digital endpoints (NDEs). For instance, digital monitoring technologies like wearables can be used to collect valuable around-the-clock patient data regarding activity and sleep. NDEs that measure sleep quality can be correlated with improved quality of life for patients with diseases such as Parkinson’s disease, rheumatoid arthritis, or depression.
Although NDEs are starting to be used in a few clinical trials, more work needs to be done to develop the framework for NDEs and gain regulatory and clinical acceptance. To accelerate this work, the Clinical Trial Transformation Initiative (CTTI) has developed a bold vision for 2030 where clinical trials not only leverage NDEs, but also utilize other digital technologies to ensure that clinical trials are patient-centric, accessible to patients, and fully integrated into our healthcare systems.