EU Regulators Told To ‘Normalize’ Decentralized Clinical Trials

EU drug regulators have received some candid responses from trial sponsors and other stakeholders on the aspects that should be urgently addressed in the next iteration of their guidance on decentralized clinical trials.
Mira Zuidgeest, Principal Investigator of the RADIAL trial conducted by the project, was interviewed for this article.

EU regulators looking for feedback on what stakeholders made of their recommendation paper on decentralized clinical trials, which was issued nearly a year ago, have been flooded with suggestions for improvement, starting with keeping an open mind and not holding DCTs to a higher degree of scrutiny than conventional site-based trials.

Regulators were told to refrain from “making assumptions” on what patients or principal investigators might prefer in a trial, and to provide guidance on how to involve local health care providers in DCTs if they are not part of the study team.

On top of that, stakeholders wanted the regulators to highlight areas of uncertainty and national differences on the acceptability of decentralized elements in EU member states, address issues around data variability and integrity, and clarify the pathway to support the faster approval of digital endpoints.

These and other suggestions were made by trial sponsors from academia and the pharmaceutical industry, as well as statisticians’ and patients’ representatives, at a multi-stakeholder workshop organized by the European Medicines Agency on 23 November. The workshop focused on ways to support the uptake of novel clinical trial methodologies, including DCTs, which allow some or all trial activities to be conducted in participants’ homes and local settings rather than at investigative sites.