Decentralised Clinical Trials and Digital Health Technologies

Health research is witnessing a rapid transition from a traditional model of in-clinic visits towards remote monitoring and data collection. Decentralised clinical trials (DCTs) move the focal point of research from the clinic to participants homes or local facilities using participant-centric approaches. The trend towards decentralisation was significantly accelerated by the COVID-19 pandemic, as remote monitoring became a key solution for continuing trials without the need for face-to-face contact (1,2).

Hybrid DCTs, which include a mix of remote and traditional settings are becoming increasingly common across all trial phases and therapeutic areas. Full DCTs, where all components occur within the participant ecosystem, are less common and likely to be later-phase or observational studies.

Decentralisation enables:

• Innovative approaches to trial design, data collection and statistical analysis
• The potential for increasing diversity, widening participation, and rapid recruitment
• Continuous monitoring, improving the efficiency and responsiveness of the trial process
• Diverse outcome measures and flexible methods of assessment
   

A key facilitator of ‘decentralisation’ has been the rise of digital health technologies (DHTs) such as telehealth, mobile apps and wearable devices, which can collect real-time data. These technologies enable high-frequency measurements within the participant’s typical daily environment, reducing the variability associated with episodic in-clinic assessments (3). However, DHTs and remote data collection also pose challenges, as measurements are taken in uncontrolled settings where contextual factors may be unknown, and missing data can be common (4,5,6).

Within the clinical trials industry recent regulatory guidance on DCTs and DHTs (7,8) has been forthcoming but there are still many unexplored operational and methodological challenges of these trial designs and few regulatory approved digital endpoints.

The journal Pilot and Feasibility Studies with an impact factor of 1.5 is planning to explore these opportunities and challenges by announcing a new Collection of Articles on Decentralised Clinical Trials and Digital Health Technologies.

The overall aim of Pilot and Feasibility Studies is to provide a peer-reviewed, high-quality forum for evidence and discourse on aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. For this Collection, we invite manuscripts that consider, but are not limited to, the following topics related to planning, conducting, and/or interpreting results of pilot and feasibility studies using DHTs for remote data collection:

• Selection, validation and feasibility of innovative outcome measures  
• Ethical and data privacy issues
• Navigating regulatory and legal challenges in DCTs and DHTs
• Health equity, participant engagement, retention, and experience
• Strategies to optimise participant adherence to DHTs
• Data security and integrity
• Managing sources of variability (e.g., device type, geographical location, setting)
• Analytic methods for processing real-time, high-frequency measurements and longitudinal data
• Approaches to addressing missing data challenges
• Economic effectiveness and cost-benefit analysis

The type of articles for this special series should include:

• Original research
• Methodology papers
• Commentaries
• Reviews
• Case Studies
• Protocols

The manuscripts are expected to follow the process of submission to Pilot and Feasibility Studies, with a flag for “Collection on Decentralised Clinical Trials” indicated in the cover letter and online submission.

References:

1. Hanley DF et al, Decentralised clinical trials in the trial innovation network: Value, strategies and lessons learnt, 2023 J Clin Transl Sci  https://doiorg.publicaciones.saludcastillayleon.es/10.1017/cts.2023.597
2. ICON White Paper: Advancing digital endpoints An end-to-end approach to managing wearable devices through clinical development    https://www.iconplc.com/insights/digital-disruption/mHealth-wearables/digital-endpoints/
3. Clinical Trials Transformation Initiative, CTTI Considerations for Developing Novel Endpoint Generated by Digital Technology for Use in Clinical Trials, 2021.  https://ctti-clinicaltrials.org/wp-content/uploads/2021/06/CTTI_Novel_Endpoints_Recs.pdf
4. Tackney MS, Carpenter JR , Villar SS, 2024, Unleashing the full potential of digital outcome measures in clinical trials: eight questions that need attention. BMC Medicine 22. https://biomedcentral-bmcmedicine.publicaciones.saludcastillayleon.es/articles/10.1186/s12916-024-03590-x
5. Tackney et al, 2024 Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event, Trials, 25:521 https://ora.ox.ac.uk/objects/uuid:7f986868-0b48-4b52-baa3-1f66a3cee75b/files/rw0892c10j
6. Abbott R, Irvin E Making the most of Biodata in remote studies.  SRA Research Matters, March 2024:9  https://the-sra.org.uk/common/Uploaded%20files/Research%20Matters%20Magazine/sra-research-matters-march-2024-edition.pdf
7. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders, FDA, Dec 2023 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations
8. Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties, FDA, Sept 2024, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements

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All submissions in this collection undergo the journal’s standard peer review process. Similarly, all manuscripts authored by a Guest Editor(s) will be handled by the Editor-in-Chief. As an open access publication, this journal levies an article processing fee (details). We recognise that many key stakeholders may not have access to such resources and are committed to supporting participation in this issue wherever resources are a barrier. For more information about what support may be available, please visit OA funding and support, or email OAfundingpolicy@springernature.com or the Editor-in-Chief.