Industry wants clarity on decentralized trials and informed consent in ICH GCP annex
Pharmaceutical industry groups in the EU are requesting more information on how to conduct decentralized trials to encourage their adoption. They also emphasized the need for clearer guidelines on informed consent in decentralized trials within the International Council for Harmonisation's (ICH) draft E6(R3) Annex 2 guideline on good clinical practice (GCP).The comments were submitted in response to the European Medicines Agency (EMA)’s call for feedback on the draft annex outlining principles for GCPs for sponsors and institutional review boards (IRBs) for collecting clinical data outside the traditional clinical trial setting, including real-world data (RWD) and data collected from decentralized trials.
ICH released the guideline to regulators in November 2024. EMA received 26 comments on the guidance from pharmaceutical groups and companies. (RELATED: ICH releases draft GCP annex, MIDD guideline, Regulatory Focus 18 November 2024)
Respondents want more clarity on decentralized trials
Respondents said they wanted more clarity on how decentralized clinical trials could facilitate clinical research. The annex defines decentralized clinical trials as “those trial-related activities conducted outside the investigator’s location (e.g., trial visit is conducted in the trial participant’s home, local healthcare centre or mobile medical units or when data acquisition is performed remotely using digital health technologies (DHTs)).”
The Association of Clinical Research Organizations (ACRO) said it “welcomes the extensive discussion of real-world data (RWD) in the draft guideline.” Yet, “The draft guideline could go much further in facilitating and enabling trials with decentralized elements,” the group wrote.
ACRO suggested that the annex should include more detailed discussions on the involvement of healthcare providers (HCPs) in decentralized trial elements. “Local HCPs are a valuable resource for decentralized trials.” However, the group said that in the Annex 2 draft guideline, the role of local HCPs in decentralized trials is mentioned only once.
ACRO recommends that the guideline include the final guidance from the US Food and Drug Administration (FDA) on conducting clinical trials with decentralized elements. The FDA guidance “provides a helpful summary of both the benefits of using local HCPs in decentralized trials and also the appropriately limited scope of a local HCP’s contributions to a decentralized trial.”
Medicines for Europe acknowledged the need for more information regarding the challenges of conducting decentralized research. The group stated that “more detailed guidance should be provided on handling specific challenges such as data integrity, participant monitoring, and regulatory compliance in these settings.”
Informed consent questions
Groups also said there is a need for clarity on how informed consent would operate in a decentralized setting, especially for diverse patient populations.
The European CRO Federation (EUCROF) said they “recommend adding guidance on monitoring participant comprehension during the informed consent process, especially in remote or technology-driven trials.”
The Lymphoma Coalition wrote that “the document lacks guidance on ensuring consent forms are understandable for diverse populations, including those with low health literacy or limited access to digital tools.”
The coalition recommended that informed consent processes should include health literacy assessments and offer information in multiple formats, such as videos, verbal explanations, and plain language documents. They also suggested providing options for human interaction, like having a patient navigator available. Additionally, informed consent materials should be accessible to participants with disabilities, utilizing formats such as Braille, sign language interpretation, or digital formats compatible with screen readers, to ensure equitable understanding and participation.
Other suggestions
Both Medicines for Europe and Teva suggested that the guidance provide more examples of how the quality by design approach can work in decentralized trials and trials using real-world data (RWD).
Medicines for Europe wrote that “the annex should provide more detailed guidance on how sponsors can effectively implement a QbD approach in clinical trials incorporating decentralized elements or real-world data.” The group suggested the use of practical examples to show how QbD could be used.
The European Federation of Pharmaceutical Industries and Associations (EfPIA) suggested the need for glossary. The group states that “a glossary would be useful to define terms such as decentralized trial, real world data – in some cases the terms are described in the text, however a reference such as a glossary would be very helpful.”
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