Finding Solutions to Legal and Regulatory Challenges of Conducting Mobile Clinical Trials

Mobile clinical trials (MCTs) offer several potential advantages, such as greater patient convenience, efficiencies in data collection, potential for novel endpoints, and enhanced participant retention.

However, despite the successful conduct of several MCTs for regulatory submission, the MCT model has yet to be widely adopted. This is due in part to presumed legal and regulatory issues in the U.S., such as the complexity of navigating different state medical licensing laws, patient and investigator oversight, and issues with the drug supply chain of custody.

In July 2017, CTTI convened a multi-stakeholder expert meeting to explore the legal and regulatory challenges inhibiting more widespread practice of MCTs, and to identify potential solutions. A meeting summary is now available highlighting main points from the discussion, including the following:

• Highly varied state laws and regulations need to be thoroughly understood and recorded in an accessible location, e.g., a public database.
• Guidance from regulatory bodies is needed to define principal investigators’ responsibilities regarding patient care oversight and potential delegation of activities,
• Trials with a mobile clinical component should not be held to higher standards than traditional trials.
• Patients and regulatory agencies should be engaged in trial design early in the development phase.

CTTI’s MCT Legal and Regulatory Project team will leverage themes and specific solutions from the multi-stakeholder discussions to develop recommendations and tools that will help address legal and regulatory challenges currently associated with MCTs.

This work is part of CTTI’s MCT Program, which is also exploring other topics and barriers related to planning for and conducting MCTs.