Table 1.

Challenges and Suggested Solutions from the Interviews and Considerations from the Expert Meeting.

Interviews: Main Perceived Challenges

• Ensuring that protocol-defined activities are carried out in a consistent manner throughout the study when relying on mobile HCPs, given the potential for varying medical qualifications of these providers and/or inconsistencies in their knowledge of the protocol • Remotely replicating the interactive part of the informed consent process, allowing investigators to gauge participant understanding and ensure that participants are adequately informed • Verifying trial participants’ identities and ensuring their privacy and confidentiality when research is completely remote • Identifying how to monitor safety within the context of remote clinical research • Planning for and implementing clinical research with telemedicine components may be difficult and time consuming due to inconsistent state telemedicine laws • Some states require a “supervising” physician be licensed to practice medicine in their state • Some states do not allow direct shipment of IMP to trial participants • Within states that allow the direct shipping of IMP to trial participants, IMP receipt and accountability is difficult because study sites are not involved in tracking the details of when an IMP is received by a study participant

Interviews: Main Suggested Solutions

• Starting trial planning early: • Engaging partners, collaborators, and stakeholders (including legal and regulatory) at the earliest stage of the clinical research trial planning and design • Reviewing and understanding individual state laws governing clinical trials, medical practice, distribution of IMP, and telemedicine • Developing systems for tracking receipt and drug accountability in remote trials • Enhancing current systems to include training and assessments for mobile HCPs • Adjusting current systems to include remote safety monitoring and privacy and confidentiality procedures • Using a problem-based design approach. For example, start with the design and build from that, rather than trying to add devices into an already established protocol • Using a participant-centered approach. For example, obtain participant feedback throughout trial design and implementation • Delineating the delegation of investigator responsibilities in the context of remote clinical research • Identifying physicians with medical licenses in multiple states • Clarifying federal regulations and standardizing state laws: • Clarifying guidance on the distribution, shipping, disposition, etc. of IMP within the context of remote clinical research • Allowing for more reciprocity between states • Staying focused and keeping the plan simple.

Considerations from the Expert Meeting

• Engage trial participants and regulatory agencies early in the trial design and development phase • Develop consensus on definitions for terms that are central to DCT design and conduct, e.g., what defines an “investigational site” in a DCT? • Glean inspiration and lessons learned from current and previous successful DCTs for implementing new DCTs • Consider fit-for-purpose study designs or starting with a DCT in which the safety profile of the IMP is well known • Highly varied state laws and regulations need to be thoroughly understood and recorded in an accessible location, e.g., a public database • Tasks or activities provided by third-party vendors may be leveraged when thoughtfully integrated in DCT design • Trials with a mobile component should be held to the same standards as traditional trials • Guidance from regulatory bodies is needed to define investigator responsibilities regarding participant care oversight and potential delegation of activities

DCT decentralized clinical trial, HCP healthcare provider, IMP investigational medical products.