Last updated: 10 February 2025
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Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products from version version 2.0 of 15 December 2022 to Version 3.0 of 5 February 2025.
- According to Swissmedic, the position paper has been extensively supplemented and updated (new version 3.0).
- One new feature is a comparison of Switzerland with European member states with regard to the feasibility of various DCT elements.
The following is a snapshot of some of the main points discussed/addressed in the position paper.
Aim of the position paper
The position paper reflects the current state of thinking of swissethics and Swissmedic on decentralised clinical trials (DCTs) with medicinal products in Switzerland interpreting their respective areas of responsibility.
The aim is to encourage and invite stakeholders to intensify the dialogue on this innovative way of conducting clinical trials and to find relevant information on the interpretation of the current legal situation in Switzerland
- This paper describes a broad variety of topics starting from the recruitment, trail conduct, sponsor- and investigator responsibilities and how oversight should be ensured in decentralised clinical trials.
- Guidance is also provided on content requirements for drafting the trial protocol, conduct of monitoring visits and task delegation. As this type of clinical trial is relatively new, changes to existing laws and regulations may be required over time and will be included in this guidance on an ongoing basis.
- In general, the developing practices associated with DCTs require careful scrutiny on a caseby-case basis for compatibility with applicable law.
About Decentralised Clinical Trials (DCTs)
When Conventional clinical trials performed with medicinal products can require trial subjects to commit a great deal of time and are also often expected to have a high degree of mobility since they have to travel to a trial site for trial-related visits.
- One objective of “decentralised clinical trials” (DCTs) is to partly transfer the trial-related visits or assessments from the trial site to the subject’s home in order to reduce the practical obstacles to trial participation and to integrate the visits more smoothly into the subject’s daily routine.
- DCTs are research projects in which the digital recording and/or transmission of data in the context of trial-related interventions play a significant role. They may involve, for example:
- digital recruitment of trial participants,
- trial visits performed using telemedicine in the patient’s home or digital recording and
- digital recording and transmission of data using wearables (computer technology worn on the body) or smart devices such as tablets or smartphones.
- Other aspects such as informed consent of subjects, monitoring and the associated verification of the source data are also affected by digital technologies
- A further characteristic element of DCTs is the direct delivery of the investigational medicinal product (IMP) to the trial subject at home, where it is stored and in some cases administered by qualified trial nurses. Wherever possible, trial-related interventions are performed and documented in the patient’s home by trained trial nurses.
Hybrid DCTs
In “hybrid DCTs” some of the interventions are performed in the conventional setting at a trial site, and others are performed in a decentralised setting in the trial subject’s home. Whether or not parts of a clinical trial can be performed in a decentralised way depends on many components – including the type of disease, the phase of the trial and the type of IMP, and on the prevailing legal framework.
International interest in DCTs
There is great interest, both internationally and in Switzerland, in performing clinical trials in a decentralised manner.
- The ICH (International Council for Harmonization) is developing a comprehensive update on the global GCP (Good Clinical Practice) Guideline ICH E6 (R3).
- Annex 1 contains considerations for interventional clinical trials and has been supplemented compared to ICH E6 (R2) with regard to DCTs by the following aspects (list not exhaustive): selection of service providers (e.g., for home nursing care) and associated agreements, qualifications of home nurses, remote consent, supply of investigational medicinal products to the patient, timely access and review by the investigator of data collected remotely, etc.
- Annex 2 addresses the GCP considerations that arise from the increased use of a wider range of design elements and data sources.
- It provides additional GCP considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic elements and/or realworld data (RWD).
- It also provides a definition of DCTs:
- On 4 May 2021, the Danish Medicines Agency published guidance on the implementation of decentralised elements of clinical trials with medicinal products. These guidelines explain the opportunities of the new trial setting and challenges while ensuring patient safety and data integrity during DCTs.
- On 14 December 2022, the European Commission Directorate-General for Health and Food Safety published the recommendation paper on decentralised elements in clinical trials. The recommendation paper addresses the roles and responsibilities of the sponsor and investigator, electronic informed consent, IMP delivery, trial related procedures at home, data management and monitoring in a decentralised clinical trial setting. It also provides an overview of the current national provisions applicable in each Member State (MS) in relation to the topics addressed in the paper.
Both Swissmedic and swissethics are committed to support researchers and sponsors in this innovative step.
- This guidance paper focuses on clinical trials with medicinal products and is intended for sponsors and researchers who are planning DCTs and want to perform them in Switzerland.
- This document considers the major challenges relating to DCTs and is based on the current position of Swissmedic and swissethics interpreting their respective areas of responsibility (art. 25 and art. 32 ClinO).
- The continuation of the present dialogue will identify areas in which further action or adaptation is required. The intention in general is not to communicate additional regulatory hurdles but rather to remove obstacles and to facilitate further innovation in clinical research in Switzerland.
- Swissmedic and swissethics are open for further mutual exchange regarding DCTs in Switzerland. This position paper contains information from existing EMA and FDA publications to DCTs, supplemented with additional content and requirements from Swissmedic and swissethics.
Information is provided in the position paper under the following headings:
1.3. Legal framework in Switzerland
2 DCT aspects
2.1. Recruitment through digital channels
2.2. Performance of trial-related interventions outside the trial site
2.3. Trial Oversight and responsibilities
2.3.1.1 Trial Protocol
2.3.1.2 Monitoring
2.3.2 Investigator responsibilities
2.3.3 Delegation of tasks
2.4. Sponsor responsibilities
2.5. Dispensing and administration/ingestion of the IMP outside the trial site
2.6. Data capture outside the trial site using mobile devices
2.7. The question of CE certification of the technology employed
2.8. Remote source data verification (rSDV)
2.9. Organisational aspects for regulatory GCP inspections
3 Summary and outlook
There is great interest, both internationally and in Switzerland, in performing fully decentralised clinical trials, or clinical trials that incorporate decentralised elements.
Both Swissmedic and swissethics are committed to support researchers and sponsors in this innovative step. This
guidance paper focuses on clinical trials with medicinal products and is intended for sponsors
and researchers who are planning DCTs and want to perform them in Switzerland.
This document considers the major challenges relating to DCTs and is based on the current
position of Swissmedic and swissethics interpreting their respective areas of responsibility
(art. 25 and art. 32 ClinO). The continuation of the present dialogue will identify areas in which
further action or adaptation is required. The intention in general is not to communicate
additional regulatory hurdles but rather to remove obstacles and to facilitate further innovation
in clinical research in Switzerland. Swissmedic and swissethics are open for further mutual
exchange regarding DCTs in Switzerland.
This position paper contains information from existing EMA4 and FDA7 publications to DCTs,
supplemented with additional content and requirements form Swissmedic and swissethics.