Program: Digital Health Trials

About This Program


Decentralized Clinical Trials

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Legal, Regulatory, and Practical Considerations Affecting the Adoption of Decentralized Clinical Trials

Telemedicine and mobile healthcare providers have been used extensively in healthcare delivery, but have yet to be widely incorporated into clinical trials. This may be due in part to legal, regulatory, and practical considerations, which are viewed as potential barriers.

CTTI has worked to address these actual and perceived challenges to conducting decentralized clinical trials (DCTs) through telemedicine and mobile healthcare providers. We have explored several topics—including telemedicine state licensing issues, FDA review division reception, and Good Clinical Practice-related issues—and created recommendations to help advance widespread use of mobile technologies in DCTs.

To support a shift in the clinical trials ecosystem - forced by COVID-19 - to plan and conduct research in remote or virtual settings, CTTI is currently working to update its DCT recommendations to ensure they reflect the latest learnings and emerging best practices from the pandemic.

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Elements of current legal and regulatory frameworks are perceived by sponsors as barriers to conducting DCTs through telemedicine and mobile healthcare providers. However, not much data exist on which elements are most challenging or how to address these concerns. CTTI has identified areas of consideration that may pose challenges:

  • U.S. Food and Drug Administration (FDA) review division receptivity/readiness
  • Institutional review boards (IRB)
  • Investigator delegation and oversight
  • Safety monitoring
  • Shipping and receiving of investigational agents
  • Telemedicine state licensing issues

Mobile Clinical Trials (MCT) Program: Decentralized Clinical Trials (DCT) (2015 – ongoing)

View other projects within CTTI’s MCT Program.

  • Identify perceived and actual legal, regulatory, and practical barriers to conducting DCTs.
  • Identify opportunities to clarify and inform policies that affect the implementation of DCTs.

Increase the number of trials leveraging telemedicine and mobile nursing to conduct decentralized trials.

Currently, the scope of the project is limited to U.S. laws and regulations; however, advances made through the project may inform progress in other jurisdictions.

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.

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.

Project Team Members

Rolesort descending Name Affiliation
Project Manager Gerrit Hamre* Clinical Trials Transformation Initiative
Project Manager Lindsay Kehoe Clinical Trials Transformation Initiative
Social Science Lead Amy Corneli Clinical Trial Transformation Initiative
Team Leader Linda Coleman Yale University
Team Leader Gary Grabow Genentech - a member of the Roche Group
Team Leader Jan Hewett Food and Drug Administration
Team Leader Barak Richman Duke University
Team Member David Babaian Quorum Review Inc
Team Member Mark Borigini Food and Drug Administration
Team Member Matthew Bryant Amgen
Team Member Paul Conway American Association of Kidney Patients
Team Member Molly Flannery Food and Drug Administration
Team Member Amy Hummel Yale University
Team Member Gracie Lieberman Genentech - a member of the Roche Group
Team Member Eeshan Khandekar* Duke University
Team Member Kristen Miller Food and Drug Administration
Team Member Laura Podolsky Science37
Team Member Vaishali Popat Food and Drug Administration
Team Member Penny Randall IQVIA
Team Member Ken Skodacek Food and Drug Administration
Team Member Marissa Stroo Duke University
Team Member Jeffry Florian Food and Drug Administration
Team Member Maria Apostolaros PhRMA