MedCity News September 11, 2024
Daniel R. Drozd

A direct-to-patient model for observational research will ease the participation burden, better incorporate the patient voice, and empower individuals to take control of their health – all while meeting the growing demands for robust evidence in developing new drugs and therapeutics.

Observational studies are critical in evaluating the long-term safety and effectiveness of new therapies on patients’ lives. However, two major shifts are significantly changing the research environment.

First, groundbreaking and often curative treatments like CAR-T cell therapies demand research that extends far beyond traditional timelines. These innovative therapies require studies spanning decades, making traditional site-based approaches impractical.

For instance, how many patients would enroll and stay engaged in a fifteen-year study? Likely none. To meet this new requirement,...

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