Table 2.

CTTI Recommendations and Considerations for Decentralized Clinical Trials.

Approaches and Protocol Design	The design and implementation of DCTs does not have to be an all-or-nothing approach. Use a partially decentralized (hybrid) approach if applicable Engage all stakeholders early and often Implement fit-for-purpose designs (see also Table 3) Proactively address and map data flow and communications Partner with those experienced with telemedicine
Telemedicine State Licensing	Maintain an investigator in each state in which the DCT is conducted Utilize investigators licensed in multiple states Contract with qualified mobile HCP research services Consult appropriate experts regarding telemedicine laws Seek reliable legal expertise and/or partnerships
Direct-to-Trial Participant IMP Accountability	Consult and ensure compliance with relevant federal and state statutes and regulations Clearly describe IMP procedures in the protocol Outline accountable parties at each step of the supply chain in the Investigational Plan Engage vendors/pharmacies with direct-to-trial participant experience
Mobile Healthcare Providers	Consider as a substitute for visits to investigative sites Delegate responsibilities consistent with state laws and the protocol, and only to qualified personnel Consider consulting/partnering with a mobile HCP vendor
Investigator Delegation and Oversight	Hold to the same standards as traditional trials Define “routine care”/“practice of medicine” as opposed to “clinical trial-related activities” clearly in the protocol Evaluate local and/or mobile HCP’s role in clinical trial and in relationship to FDA regulations Delegate authority and responsibilities in the same way as for traditional trials Consult FDA regulations and guidance when determining whether or not and how to list HCPs on the Form FDA 1572
Safety Monitoring	Hold to the same standard as traditional trials Clearly articulate remote safety monitoring procedures and train investigative staff Establish record-keeping protocol to ensure compliance Develop protocol-specific safety monitoring and communication escalation plans

DCT decentralized clinical trial, FDA Food and Drug Administration, HCP healthcare provider.