The Principal Investigator (PI) has the responsibility to oversee all trial related activities including any activities delegated to other personnel. To protect participants’ rights, safety, and welfare, the PI must have the human and technological resources to implement the trial as designed, assess adverse events, and ensure the conduct appropriately minimizes risks to participants. In decentralized trials, a 3rd party vendor may be engaged to perform in home services. PI and institution may have other concerns about meeting requirements for ensuring adequately qualified staff, providing training on the protocol, and assuring the integrity of study data.
Ethics and Regulatory:
- Guidance from regulatory bodies is needed to define investigator responsibilities regarding participant care oversight and potential delegation of activities in a decentralized model.
- Investigator delegation and oversight: sites may be hesitant to act as the REB of record for a sponsor-engaged vendor over which it has little actual authority.
- Evaluate local and/or mobile HCP’s role in a clinical trial and in relationship to regulations.
- Sponsor, CRO and site must maintain current and up to date knowledge of legal and regulatory landscape as it applies to use of remote in person and virtual telepresence.
Privacy and IT :
- Consider using sites that are familiar with and have robust telemedicine systems in place and significant user awareness.
- PI must be licensed in jurisdictions in which study participants reside.
- Investigator delegation and oversight must meet the same standards as traditional trials.
- Sponsors may need to offer contractual indemnification related to that activity of 3rd party vendors.
- Sponsors and sites must consider appropriate site management strategies:
- Sites should decide who is responsible for the management of source documents at decentralized sites (i.e., source documents from local physicians, or source documents generated by study participants and collected at home visits by the clinical investigator, trial personnel, or third-party vendors.)
- Sponsors and sites should indicate where and how local source documents and electronic information will be stored.
- Technological support and training should be provided for all who will be using the clinical trial technology (e.g., local physician/HCP, trial participant, and/or their caregiver).
- The sponsor, CRO or trial site should ensure that only the study participant or other appropriate study-related personnel enters data when a device is used for data collection.
- Investigators should train staff on processes unique to decentralized clinical trials.
- Trial participants should be educated on what to do in the case of an adverse event.
- Sites and the PI must consider requirements for trial-specific procedures to determine:
- Activities that must occur at the investigative site (e.g., due to equipment/facility requirements or medical expertise).
- Activities that can be performed by a local or mobile healthcare provider who can travel to the trial participant.
- Activities that are able to be performed remotely using virtual solutions.
- “Routine care” and “practice of medicine” and “clinical trial-related activities” should be defined in the decentralized clinical trial context. These terms are generally understood within traditional trials with pre-specified investigative sites but may not be as clear in decentralized trials.
- Safety monitoring must be held to the same standard as traditional trials.
- Investigative staff must be trained in remote safety monitoring procedures.
- A record-keeping protocol should be established to ensure compliance and a protocol-specific safety monitoring plan, and a communication escalation plan should be developed.
- If mobile healthcare providers are able to perform clinical assessments, blood draws, IMP or treatment administration, participant education, and in-home compliance check, these tasks should be assigned to qualified personnel required by the protocol, as informed by scope of practice parameters defined by applicable regulatory bodies.
- Trial operators using mobile healthcare providers should create SOPs focused on applicable activities, such as specimen storage and shipping, as well as basic policies around travel and accommodations
- Sponsors should consider engaging PIs that have experience with integrating mobile care into clinical trials.
Patient / Caregiver:
- Sites with larger participant pools will require partnerships with local and mobile healthcare providers to account for additional participants under their care and to manage any distance that cannot be bridged by virtual means.
- Communication is key for the participant. Having a primary point of contact for the study is important.
Opportunity to improve access to/uptake of decentralized approaches:
- Develop guidance on PI oversight when a patient is transferred to another institution
- Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018
- 3-CTN CRAFT Framework
- Apostolaros, M., Babaian, D., Corneli, A. et al.Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci 54, 779–787 (2020). https://doi.org/10.1007/s43441-019-00006-4