Initial input on legal, regulatory, and practical challenges was solicited from sponsors during interviews conducted between October 2016 and January 2017. Particular challenges were identified including, but not limited to: the complexity of navigating different state laws and regulations; the need for physicians with licensing in multiple states; issues with the drug supply chain of custody; legal responsibilities of the principal investigator (PI) regarding trial oversight and patient care; and clarity regarding regulatory agency receptivity.

In July 2017, CTTI convened a multi-stakeholder expert meeting to engage stakeholders in deep discussion, grounded in data and experience, to identify solutions to the legal and regulatory challenges inhibiting the widespread adoption of mobile technologies in DCTs. Themes from the meeting included:

• Current state laws and regulations are highly varied, including drug supply considerations with investigational and marketed products, and therefore need to be thoroughly understood and recorded in an accessible location (e.g., a public database).
• Guidance, or modification to existing guidance, is requested by investigative sites, industry sponsors, and IRBs to delineate the PI’s responsibilities regarding patient care oversight and potential delegation of activities.
• Guidance from regulatory bodies is of particular interest.
• MCTs should not be held to higher standards than traditional trials, and issues common to all clinical trials should not be a more daunting hindrance to MCTs.
• This effort should strive to engage patients and regulatory agencies in trial design early in development.
• Consensus is needed on definitions for terms that are central to MCT design and conduct:
• What defines a “site” in an MCT?
• What is included in “standard medical care,” and how would this differ from “treatment” or “research?”
• Inspiration for the design and conduct of MCTs can be gleaned from current and previous successful remote clinical trials.
• Tasks or activities provided by third-party vendors may be leveraged when thoughtfully integrated in MCT design.

A meeting summary is available with more details on topics discussed. 

In September 2018, CTTI released final recommendations on overcoming the legal, regulatory, and practical hurdles for planning and conducting DCTs. These evidence-based and practical recommendations address barriers—including varying state medical licensing laws and issues with the drug supply chain of custody—that could be hindering the widespread use of DCTs. Other recommendations are related to DCT protocol design, investigator delegation and oversight, use of mobile health care providers, and safety monitoring.