Euro Roundup: Swissmedic updates position on decentralized clinical trials

The Swiss Agency for Therapeutic Products (Swissmedic) has “comprehensively amended and updated” its position paper on decentralized clinical trials (DCTs), including a comparison of what decentralized aspects of trial design are allowed in Switzerland and other European countries.

Swissmedic published the second version of its DCT position paper in conjunction with the Swiss Association of Research Ethics Committees, late in 2022. That eight-page document described DTCs, the legal framework in Switzerland and the acceptability of specific decentralized design elements such as recruitment through digital channels and remote data capture.

In the latest paper, Swissmedic and swissethics have added two new sections to the list of DCT elements, created three appendices, and made changes to the existing text. The two new sections cover trial oversight and responsibilities and organizational aspects for good clinical practice inspections.

The oversight and responsibilities section states sponsors must define the roles of third-party service providers such as home nurses. As in centralized trials, Swissmedic expects sponsors to define the roles and responsibilities of all personnel in a site-specific delegation log, but the agency said decentralization poses particular challenges.

“A decentralized study sets higher demands on the oversight on both the investigator but also the sponsor to ensure the safety and well-being of the trial participants as well as the credibility of the data collected,” the paper states. “It must be ensured by design, how the sponsor and the investigator can fulfil their duties and responsibilities.”

The oversight and responsibilities section features multiple subsections about the sponsor, trial protocol, monitoring, investigators, and the delegation of tasks. The subsections explain what sponsors need to do in relation to data management plans, study oversight, describing the operational aspects of the trial in the protocol and ensuring the predefined monitoring plan is followed.

Delegating tasks “is of key importance and requires thorough oversight of all parties involved,” Swissmedic said. Sponsors that delegate tasks to service providers should include “a high-level rationale and extent of their involvement” in the protocol and “a more detailed description” in a referenced document.

The first of three new appendices features a table about what is allowed in different European countries. The table features questions about DCTs, such as “Is it possible to deliver [investigational medicinal products] directly to trial participants from any delegated pharmacy” and yes/no answers for European countries. The table shows Switzerland allows more DCT elements than many European countries.

Swissmedic Notice

MHRA creates decision tree to address uncertainty about regulation of nanomedicines

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a decision tree to help researchers use international and European guidelines to support nanomedicine development.

MHRA said it has “received an increase in interest and scientific advice queries on nanomedicines in recent years, particularly on lipid nanoparticles (LNPs).” LNPs are vehicles that enable the delivery of medicinal products such as mRNA vaccines.

“There appears to be a perception that there is no clear regulatory pathway available for these products and researchers are unclear how to develop their products in accordance with the various guidelines currently in place,” MHRA said.

The decision tree is intended to clear up the uncertainty by guiding researchers to the relevant guidance. The tree features a series of questions, such as “Is it a biological product?” By answering the questions, researchers are guided toward documents such as a European reflection paper on liposomal products and guidelines on biosimilars that may be applicable to their programs.

MHRA said the tree “may help support development of medicinal products involving ‘nano’ drug delivery systems,” but the tool has limitations. The list of regulatory documents is “not meant to be exhaustive,” MHRA said, and “the nanomedicine decision tree is not considered as a substitute for a regulatory or scientific advice meeting.”

MHRA Notice

MDCG shares advice on how notified bodies can avoid unnecessary work duplication

The Medical Device Coordination Group Document (MDCG) has updated its advice to explain how notified bodies can use previous assessments to avoid unnecessary duplication of work.

In 2022, MDCG responded to notified body capacity constraints with a position paper that encouraged organizations to “develop a framework for leveraging evidence” to avoid the unnecessary duplication of work.

“Manufacturers and notified bodies should discuss and agree in the pre-application phase if / which evidence provided with previous applications by the manufacturer can be referred to,” MDCG said. “In principle, this is possible as long as the evidence provided still meets the ‘state of the art’.”

MDCG said manufacturers can facilitate the approach by clearly indicating “which parts of a technical documentation have changed compared to previous ones.” Notified bodies can then make use of their previous assessments of the evidence.

Such reuse is “generally recommended” provided certain conditions are met, MDCG said. Requirements such as harmonized standards cannot have changed since the previous evaluation and the original assessment must have been performed by personnel who meet the qualification requirements. Finally, reporting requirements must be met and traceability ensured.

MDCG Paper

European Commission discusses medical devices in guidelines on AI system definition

The European Commission has published guidelines on the artificial intelligence system definition to facilitate the application of new legislation.

The first rules under the AI Act, including the AI system definition, took effect on 2 February. To help companies determine if software constitutes an AI system, the Commission has approved draft guidelines on the definition. The guidelines feature references to medical devices.

The Commission cited “medical device diagnostic systems trained on medical imaging labeled by human experts” as an example of an AI system based on supervised learning. Such AI systems learn from labeled data and generalize the knowledge to new, unseen data, for example, to support the analysis of medical images.

The guidelines also reference “early generation expert systems intended for medical diagnosis.” Such systems, which are an example of AI based on logic, are developed by encoding knowledge of a range of medical experts and “intended to draw conclusions from a set of symptoms of a given patient.”

Press Release

EMA task force plans update to COVID-19 vaccine reflection papers, flu vaccine guidelines

The European Medicines Agency’s (EMA) Emergency Task Force has outlined plans to update reflection papers on COVID-19 vaccines and guidelines on protecting against influenza.

In its three-year work plan, the task force said, “The current guidance documents for vaccine development need to be revised based on current criteria for approval of new COVID-19 vaccines.” The planned changes will address “guidance on immuno-bridging strategies and scenarios in which use of immune makers for inferring protection is not appropriate.”

The task force also plans to update a 2016 guideline on the clinical and non-clinical modules for flu vaccines. Since the text was published, several requests for scientific advice and marketing authorization applications “have pointed to the need to update and clarify certain sections of this guidance to make it clearer and more comprehensive on specific matters,” EMA said.

Work Plan

Euro Roundup: Swissmedic updates position on decentralized clinical trials

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