In trials using decentralized elements, sponsors and investigators have ultimate responsibility for ensuring the integrity of the data generated, says a draft EU guideline, placing additional oversight duties on their plates.

The release of the paper by the European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies comes at a time when researchers have expressed concern about regulatory barriers to decentralized trials (DCT) (CenterWatch Weekly, Dec. 12).

“Introducing decentralized elements should be considered as an extension of the … site with the inclusion of the trial participants’ home, resulting in an additional obligation of oversight for investigators and sponsors,” the draft says.

“The protocol should reflect that the sponsor and the investigator are in full control of their respective areas of responsibilities at all times, e.g., with respect to the data processing, the communication flow and, ultimately, the rights, safety, dignity and well-being of the trial participants and reliability of the trial data,” the paper reads.

For example, sponsors and investigators should ensure the assignment of activities to different parties is well defined whenever a DCT methodology is introduced. Clearly document which tasks are done when, by whom and in which setting, such as at the trial site or the patients’ homes, as well as how the required oversight by the sponsor or investigator will be achieved. An overview of the workflow for these tasks should be laid out generally in the protocol and in greater detail in a protocol-related document, the guidance says.

In addition, trial-specific activities shopped out to a service provider should be specified in a written agreement between the responsible party (as directed in ICH E6) and the provider.

When a sponsor chooses a provider and the investigator is not involved in the agreement, the contract between the sponsor and investigator should clearly document that agreement between the sponsor and service provider when it relates to tasks under the investigator’s responsibility, the guidance says. By doing this, the investigator can agree or disagree to the use of service providers for medical care-related trial tasks.

The guidance also offers the EMA’s perspective on informed consent in DCTs, the delivery and administration of investigational products at home, the conduct of trial-related procedures at home, data collection and management, and trial monitoring.

Read the full draft guidance here: https://bit.ly/3hDQLau.