Navigating Licensing Laws And Regulations On Decentralized Clinical Trials That Cross State Lines

Multistate studies have only increased with the widespread adoption of decentralized and hybrid clinical trials. The research style makes it easier for patients to participate in clinical trials from almost any location, thereby making it easier for studies to span multiple states. According to reports, more than 300 trials used digital data collection in 2021. That same year, almost 90% of sponsors used decentralized technology in at least one of their trials.⁴ To compare, from 2010 to 2016, only 25 DCTs were happening each year.³

DCTs and the research access they enable benefit every stakeholder in the clinical trial process: sponsors get more sites and patients, leading to faster research, and more sites can feed their research interests, help advance medicine, and augment their patient care. Patients also benefit from DCTs, as these trial models enable research participation with fewer life disruptions, increased access to new or advanced care, and the ability to improve medicine for loved ones and future generations. However, DCTs also come with unique challenges. Perhaps the most frustrating are the inconsistencies in state laws and regulations on medical licensing.

Take a deep dive into the various laws and regulations surrounding multistate licensing for clinical research. This paper will describe the differences in license requirements between PIs and sub-investigators, provide operational guidelines to ensure compliance, and explore additional considerations to set studies up for success.