Observational studies are essential for assessing the safety and effectiveness of new therapies over time. There are two major shifts in the research environment: the need for longer, patient-centric studies for innovative therapies like CAR-T cell treatments, and the growing demand for patient involvement in the research process. To address these shifts, a new model of observational research is needed, one that is flexible, sustainable, and inclusive of the patient voice. Utilizing technology and regulatory support, a direct-to-patient approach can ease participation burdens, enhance data quality, and improve patient engagement, ultimately leading to better outcomes in developing new treatments.
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A Tailor-made Approach to Simplify Observational Research
