Decentralised Clinical Trials: Advancing Accessibility and Innovation
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There is a growing focus on decentralised clinical trials across Europe. This page provides information about DMP’s work in this area and developments happening across the continent.
What Are Decentralised Clinical Trials?
Traditionally, clinical trials are conducted at dedicated study centres or hospitals, where participants attend in-person for examinations and to receive investigational medicinal products. However, clinical trials are evolving rapidly, with increasing adoption of digital tools and decentralised approaches.
Decentralised clinical trials utilise technologies such as digital consent, virtual consultations, electronic data collection systems, and wearable devices that measure activity or outcomes. These innovations enable parts or even the entirety of a trial to be conducted remotely, without participants needing to visit a study centre or hospital.
This approach opens up new possibilities for conducting clinical trials, promoting greater equity in access to healthcare across regions, and making it easier for patients to participate in trials.
DMP’s Classification of Decentralised Clinical Trials
DMP categorises decentralised clinical trials into three models:
Conventional Trials
- Conducted at dedicated study centres with investigator teams.
- Participants travel to the study centre for all trial activities.
- Monitoring is conducted on-site.
Hybrid Models
- Some aspects of the trial are conducted at the study centre, while other elements are carried out remotely.
Fully Decentralised Trials
- All trial activities are conducted remotely.
- Data collection and participant follow-up are facilitated through telemedicine, digital technology, or local healthcare services.
- Investigational medicinal products are delivered directly to participants.
DMP’s Role in Decentralised Clinical Trials
Implementing decentralised trials requires new infrastructure, expertise, and support for those conducting the studies. DMP is committed to fostering competency development and facilitating the efficient execution of these innovative trial models.
DMP encourages dialogue with stakeholders and welcomes applicants to advisory meetings before submitting any type of application. This collaborative approach ensures that sponsors and researchers are equipped to navigate the complexities of decentralised trials effectively.
What’s Happening in Europe?
Across Europe, various initiatives are underway to support decentralised clinical trials. During the COVID-19 pandemic, the European Commission published guidance on conducting clinical trials during a pandemic, which includes recommendations for decentralised elements. These documents are available on the European Commission’s website (external link).
Building on this, three working groups within the European regulatory network—Clinical Trials Coordination Group (CTCG), Clinical Trial Expert Group (CTEG), and GCP Inspectors Working Group (GCP IWG)—are actively working on this topic.
The working groups have published a Recommendation Paper on decentralised elements in clinical trials. You can access the document here.