Swissmedic has published an eight page position paper on Decentralised Clinical Trials (DCTs) with medicinal products. This position paper could be of interest amongst other, to anyone who has an interest in the increasing digitisation and/or digitalisation of clinical trials.
There is great interest, both internationally and in Switzerland, in performing clinical trials in a decentralised manner.
- The ICH (International Council for Harmonisation) is planning to develop an Annex 2 on the topic of “Additional considerations for non-traditional interventional clinical trials” as part of the modernisation of the global GCP (Good Clinical Practice) Guideline ICH GCP E6 (R2). Work on drafting the Annex is already scheduled. Additional considerations for DCTs will be one of the topics specified in detail in this document.
- 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.
About Decentralised Clinical Trials (DCTs)
The development of novel technologies and digitalisation in the field of therapeutic products offers new opportunities. According to the paper, 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 transmission of data using wearables (computer technology worn on the body) or on 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.
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.
Perceived advantanges of DCTs
Stakeholders involved in clinical trials in Switzerland are convinced that DCTs are set to play an increasingly important role in the future. At the Swissmedic Round Table Innovation event held in October 2019 the stakeholders emphasised their wish to support innovation in Switzerland in this context.
In an introductory summary they stated their intention of giving potential subjects in Switzerland the opportunity to take part in DCTs. The anticipated advantages are the following:
- rapid, digital recruitment through new channels;
- trial implementation that can be better integrated into trial subjects’ day-to-day routine by reducing the time and mobility required;
- digital automation of data capture with a possible improvement in data quality;
- possibility of performing clinical trials for rare diseases.
The paper provides further detail on all of the following aspects in relation to DCTs:
- Legal framework in Switzerland
- DCT aspects -In regulatory and ethical terms there are four main aspects related to DCTs, which are considered in detail below.
- Optimal medical care, the rights and safety of subjects must be ensured at all times.
- The IMP must be safely dispensed, ingested/administered and returned.
- The data recorded during the clinical trial must be credible and reliable.
- The data protection requirements must be met in full.
- Recruitment through digital channels
- Performance of trial-related interventions outside the trial site
- Dispensing and administration/ingestion of the IMP outside the trial site
- Data capture outside the trial site using mobile technologies
- The question of CE certification of the technology employed
- Remote source data verification
Source: Swissmedic website