11/18/2024
Photo by Marcelo Leal on Unsplash
On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT). Decentralized elements are a relatively new innovation to clinical trials with the advances in digital health technologies (DHT), that allow of many trial-related activities to be done remotely by transmitting data from the participant’s location to the trial site or the clinical laboratory facilities. Decentralized elements include but are not limited to:
Home Health Care Provider Visits: Qualified site staff or contracted health care providers (HCP) may go to participant’s homes to conduct tests, questionnaires, or other trial-related activities, this can be very beneficial for participants who struggle with mobility and travel.
Local Health Care Visits: On top of the routine health care participants receive at their local HCP, trial-related activities can also be conducted at the same time and place which is often more convenient for participants and can reduce the number of missed visits.
Telehealth Visits: Many questionnaires able to be done over the phone or video calls with qualified site staff which, again, is often more convenient for most participants especially those that have issues making it to the trial site on time for their scheduled visits.
While these decentralized elements can streamline many processes within trials, they also can present quality and reliability issues to the trial data if not properly implemented or lack effective oversight. An important concept that the guidance reiterates in multiple sections is to have the decentralized elements outlined in the trial protocol in order to limit variability in the data collected and ensure the integrity of the trial. Outlined points in the protocol can include:
What trial-related activities/visits can be performed remotely.
Who is qualified to perform remote trial-related activities.
How adverse events should be identified and reported remotely.
What DHTs are acceptable during the trial.
The longest section of this guidance is “Roles and Responsibilities” which is subcategorized into “Sponsor” and “The Investigator and Delegation of Trial-Related Activities”. On top of all the responsibilities the Sponsor has in non-DCTs, when adding the decentralized elements, they are also responsible for ensuring the protocol addresses all of the points mentioned above, as well as making sure the decentralized elements are being properly monitored and are in compliance with local laws and regulations. Decentralized elements will often include CRO’s, such as networks of HCPs, which will require further coordination by the Sponsor in order to ensure these contracted services are following the trial protocol. Choosing the investigator is still the Sponsor’s responsibility in a DCT, however, once chosen the investigator must further delegate trial related activities to qualified site staff or to the contracted HCPs and is responsible for keeping track of how the trial is being conducted when decentralized elements are in use.
The entire guidance can be found on the FDA’s website here and is open to comments from the public at any time. Those who wish to comment can find the link here. DCTs have been a growing point of interest in recent years as technology continues to provide new ways to conduct trials from outside of the trial site while maintaining the security and integrity of the data. Clinical Pathways has done multiple blog entries on the subject (links will be provided below for those who are interested in learning more) and will continue to post more as new developments from the FDA unfold. If you would like to be kept up to date on topics such as DCT as well as other FDA activity, please consider signing up for the Clinical Pathways’ newsletter at the following link: https://www.clinicalpathwaysresearch.com/blog.
-The Clinical Pathways Team
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