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.
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:
Mobile Clinical Trials (MCT) Program: Decentralized Clinical Trials (DCT) (2015 – ongoing)
View other projects within CTTI’s MCT Program.
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:
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.
|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|