This statement aims to confirm the current UK position on the use of Decentralised Trial (DCT) methods for trials involving investigational medicinal products. In this context DCT methods are trial-related activities that occur at locations other than clinical trial investigator sites. These trial-related activities may take place digitally, or at homes of trial participants or at health care or other facilities which are local to trial participants. This statement relates primarily to clinical trials of investigational medicinal products (CTIMPs) but the principles that apply to decentralised trial methods can be extended to other types of trials and investigations.
Technological advances with electronic communications and health data monitoring and collection mean that the need for in-person visits to clinical sites have reduced, in a clinical trial as well as clinical care context. Remote participation in clinical trials can be more convenient and reduce burden for trial participants and caregivers, better enabling equity of access. It can also make it easier for patients with rare diseases and reduced mobility to take part in clinical trials. This in turn may help improve trial participant engagement, recruitment, enrolment, and retention with a meaningfully diverse patient population. It also enables research to be delivered more sustainably.
Clinical trials must comply with relevant regulatory frameworks. Clinical trials of medicinal products must comply with the Medicines for Human Use (Clinical Trials) Regulations 2004 and comply with the International Conference on Harmonisation (ICH) conditions and principles of Good Clinical Practice (GCP). This current regulatory framework does allow for decentralised trial methods. However, the Clinical Trial Regulations and ICH-GCP (E6) are currently under revision and in part aim to better reflect advances in technology and provide for more flexible approaches to clinical trial delivery. The Health Research Authority (HRA), our partners in the devolved administrations in Wales, Scotland and Northern Ireland, and the Medicines and Healthcare products Regulatory Agency (MHRA), support and encourage remote trial delivery where safe and appropriate. Detailed guidance will be issued in due course to support revisions to the clinical trial regulations and ICH-GCP E6.
Key considerations for use of decentralised trial methods
- sponsors should involve people with relevant experience, including patients, family members and carers, in the design of trials which apply decentralised methods. This is to ensure assumptions are not made about the locations, methods or technologies that will work best participants
- sponsors must assess, verify and validate the technology, methodology and usability of any novel digital or other end-points that will be used to collect data directly from participants
- sponsors must do ongoing risk assessment to ensure that decentralised trial methods maximise the benefit to participants, without compromising participant safety and trial oversight. Sponsors should consider factors such as disease, developmental stage of the treatment, administration of the treatment, trial population and the reliability of assessments
- risk assessments must be clinically informed, and sponsors should consult relevant investigators to address the implications for investigator sites, and to ensure that the trial design allows for appropriate investigator oversight
Links to key resources
The National Institute for Health and Care Research (NIHR) has issued preliminary guidance from its Remote Trial Delivery Working Group. This guidance aims to provide support and practical examples for study teams, investigators and sponsors to adapt existing studies and design and plan new studies.
The Association of Clinical Research Organisations (ACRO) has released a decentralised trial toolkit which contains four resources to support planning and delivery of patient-centric clinical trials.
- Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralised Clinical Trials
- QbD Manual for Decentralised Clinical Trials: The Quick Reference Guide
- Decentralised Clinical Trials Risk Assessment Considerations
- Decentralised Clinical Trials Data Flow Maps
MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions.
Guidance on proportionate methods of providing participant information and seeking consent, that may be appropriate in some decentralised trials.
Guidance on investigator oversight and contractual arrangements for use when different locations are involved in delivering a trial.