This blog post provide basic information on decentralised clinical trials and links to guidance/resources available in various countries/region(s).
What is decentralisation?
Clinical trials on Investigational Medicinal Products are increasingly using procedures
conducted outside the traditional ‘clinical trial site’, a concept usually referred to as
decentralisation.1
What is the aim of decentralised clinical trials (DCTs)?
Traditionally, clinical trials have been conducted at specific clinical trial sites to which patients have to travel. 2
- The aim of DCTs is to make it easier for patients to participate in clinical trials by reducing the need to travel to central trial sites.
- This approach has the potential to make clinical trials available to a wider demographic of participants and reduce drop-out rates.2
How is decentralisation achieved?
Decentralisation is achieved by the advancement of digital tools, telemedicine and more mobile and local healthcare. It includes aspects such as: 2
- home health visits
- remote monitoring and diagnostics
- direct-to-patient shipment of study drugs
- electronic informed consent
Activities in a decentralised clinical trial
In a decentralized clinical trial (DCT), some or all of a clinical trial’s activities occur at locations other than a traditional clinical trial site. These alternate locations can include the participant’s home, a local health care facility, or a nearby laboratory.3
Why are DCTs and DHTs (Digital Health Technologies) becoming more prevalent?
DCTs and DHTs are gaining traction for many reasons. Technologies are improving, making it easier to collect, transfer, and store electronic data. Patients and providers are becoming much more tech savvy and comfortable with telemedicine.3
On a practical level, DCTs can reduce time and expenses in the long term, limiting or eliminating the need for the resources associated with a traditional site. However, there may be upfront technology and training costs.3
What are some of the the challenges with DCTs and DHTs?
While DCTs and DHTs can reduce barriers to clinical trial participation, they also introduce technical hurdles. People uncomfortable with wearable sensors, those without access to technology, and those who are unfamiliar with electronic instruments like cell phones and smart watches may opt out of participating. As a result, the clinical trial participants may be younger and more tech savvy than the actual patient population.
Available guidance/resources on DCTs by country/region:
| Country/Region | Agency/organisation | Webpage (if available) | Guidance/resources |
|---|---|---|---|
| Australia | ARCS | Common Terminology for Decentralised Trials (white paper, May 2023) This document was developed and released by ARCS Australia for those involved in the design, conduct or oversight of DCTs to ensure clear and effective communication between these stakeholders. It will require amendment as governance arrangements for the conduct of DCTs are developed and emerging technologies supporting DCTs are validated | |
| Canada | Health Canada | Consultations on clinical trials regulatory modernization initiative (spring and summer 2021) | |
| Denmark | Danish Medicines Agency | Guidance on the implementation of decentralised elements in clinical trials with medicinal products | The Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal products (September 2021) The purpose of this document is to provide guidance on the implementation of decentralised elements in clinical trials with medicinal products and to highlight challenges. |
| European Union | European Medicines Agency | Facilitating Decentralised Clinical Trials in the EU | Recommendation paper on decentralised elements in clinical trials Version 01, 13 December 2022 (HMA, EMA, European Commission) The paper recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected |
| Sweden | Swedish Medical Products Agency | Decentralised Clinical Trials | |
| Switzerland | Swissmedic | Position Paper on decentralised clinical trials (DCTs) with medicinal products in Switzerland (version 2.0 Dec 15 2022) This 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 in conducting clinical trials. | |
| USA | FDA | The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies | Decentralized Clinical Trials for Drugs, Biological Products, and Devices (Draft Level 1 guidance, May 2023) This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. In fully decentralized clinical trials, all activities take place at locations other than traditional trial sites |
Further reading
- Why Asia-Pacific is the next frontier for decentralised clinical trials, Juliet Martin, 5 January 2022, clinicaltrialsarena.com
- Interest in Decentralized Trials Rising in Asia-Pacific, Ryan Jiang and Wai Hong Yuen, 2 December 2022, pharmasalmanac.com
- Enhancing Patient-Centric Outcome measures and clinical trials with digital health technologies 12 -13 December 2022, EFPIA
References
- Recommendation paper on decentralised elements in clinical trials Version 01, 13 December 2022 (HMA, EMA, European Commission)
- Facilitating Decentralised Clinical Trials in the EU (EMA, 19 December 2022)
- The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies (FDA)
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