06/06/2023
Photo by Karsten Würth on Unsplash
The U.S. Food and Drug Administration (FDA) announced that the “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” draft guidance is available for comment. When finalized, the draft guidance fulfills the requirement for guidance on decentralized clinical trials under Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA).
Decentralized clinical trials (DCTs) are clinical trials where some or all of the trial related activities occur outside of a traditional clinical site. For example, this could be in the participant’s home or a local healthcare facility, and can utilize home health care providers, local health care providers, or telehealth. The investigational product is shipped to the participant’s home. The trial is considered hybrid if there is a combination of both onsite visits and remote activities.
The draft guidance recommends using a risk based approach to decision making regarding the use and extent of remote trial activities. Also recommended is an awareness of the potential for variability in the approach to trial related activities; quality control measures and regular review of data should be utilized to reduce the risks.
Some important considerations included in the draft guidance are:
Remote Visits:
Telehealth may be used when no in person assessment or activity is needed.
Some study related activities can be completed using local, non study related personnel. Complex or detailed study specific assessments should be completed by qualified personnel.
Identification of the participant is needed for each remote visit.
Digital Health Technologies (DHTs)
DHTs may be used for transmitting data back to the CRO or sponsor.
Roles and Responsibilities
The sponsor’s responsibilities are the same as for traditional clinical trials.
Oversight is even more important for DCTs.
One benefit of DCTs is the increased outreach possible, so sponsors are encouraged to include diverse populations as much as operationally feasible.
The protocol should describe how DCTs will be implemented.
The investigator’s responsibilities are the same as for traditional clinical trials.
The main difference is the oversight of remote visits and coordination with local healthcare providers.
Local healthcare providers who conduct trial related activities should be documented in a task log, which may be inspected by the FDA.
Informed Consent and Institutional Review Board (IRB) Oversight
Remote informed consent or electronic informed consent is permitted.
A central IRB is recommended.
Investigational Products (IP)
The safety profile and nature of the IP and the level of care needed after administration should be considered.
IP can be shipped directly to the participant’s home or local healthcare facility.
If the IP is considered safe to do so, the IP may be administered by a local healthcare provider or study representative.
Safety Monitoring Plan (SMP)
SMPs should adequately describe how the participant should report adverse events, contact site personnel, and seek follow up medical care.
The plan should describe what safety information the DHT will collect.
Software
Software used in the creation of clinical trial data fall under 21 CFR Part 11 requirements.
Telehealth visits are considered as live interactions and are not subject to Part 11.
The draft guidance is largely an expansion of some of the recommendations that stemmed from the pandemic that are included in the updated March 2020 guidance “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency.” The success of ongoing trials during the pandemic helped increase stakeholder acceptance of remote clinical trial activities and pathed the way for the modernization of clinical trials and DCTs.
Comment now through August 1, 2023 HERE.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.