Decentralized trials getting some attention on the international regulatory front

Updated 5 April 2023 to correct a reference ot the RADIAL trial*

BASEL, Switzerland – Work is progressing to overcome the obstacles associated with European decentralized clinical trials and advance their adoption, regulatory and industry officials said during a panel session at DIA Europe 2023. An upcoming guideline from the International Council on Harmonisation (ICH) may soon boost these efforts.
 
At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed some of the current challenges in conducting decentralized clinical trials in the EU, where differences among member states hinder its adoption among sponsors.
 
Monique Al, a scientific staff member for the Central Committee of Research Involving Human Subjects (CCMO), noted much regulatory “disharmony” in the EU regarding decentralized clinical research. CCMO is a government agency based in The Hague, Netherlands, established by the Dutch Medical Research Involving Subjects Act.

EU member states differ in their acceptance of electronic informed consent and e-signatures and their procedures for shipments of medicinal products to patients, home health visits, remote monitoring, and remote source data verification.
 
Panelists discussed ongoing studies exploring these discrepancies and proposed solutions to overcoming these obstacles.
 
There are different expectations regarding the level of detail for elements of decentralized clinical trials. While some health authorities accepted these protocols, others rejected them. Different countries requested different information from these trials. Also, some decentralized elements were not always consistent with the EMA’s recommendations on decentralized trials, released in December 2022 (RELATED: EMA recommendation paper: Safety, data integrity key to decentralized trial conduct, Regulatory Focus, 15 December 2022).
 
Scott Askin, global program regulatory director for Novartis in Basel, Switzerland, discussed learnings from a recent trial called RADIAL (Remote and Decentralized Innovative Approaches to clinical trials) submitted to the CTIS portal in March of last year.
 
He also discussed a recent paper from Trials@Home with some of the learnings of decentralized trials. The paper found that ethics reviews of decentralized clinical trials stress potential risk and that risk aversion may result in the overregulation of decentralized research. Trials@Home is an industry/academic consortium that aims to foster the use and acceptance of decentralized clinical trials in Europe.
 
From a regulatory standpoint, Andrew Thompson, a statistician with EMA, told the gathering that “it is your job to tell me whether to trust the data.” He added that while the agency accepts decentralized trials, it is not an “all or nothing proposition” and that applications can contain data from traditional and decentralized trials.
 
In the meantime, he highlighted an upcoming ICH to harmonize the principles and elements of conducting decentralized clinical research. The guideline will be an Annex 2 on the topic of “Additional considerations for non-traditional interventional clinical trials” and will complement the ICH Good Clinical Practices (GCP) E6(R2) guideline.
 
As a result of all this attention on decentralized trials, “we’re getting better” at conducting decentralized trials. Still, more work needs to be done in this area, especially to increase the diversity of clinical trial participants, said Lada Leyens, regulatory senior program director for F. Hoffmann-La Roche.
 
DIA meeting

A previous version of this story incorrectly referred to RADIAL as a mock trial. Regulatory Focus regrets the error.