D1.1 First set of recommendations for RDCTs (to be implemented in the pan-EU pilot DCT)

Amy Rogers; Isla Mackenzie; Hawkins Kimberley

D1.1 First set of recommendations for RDCTs (to be implemented in the pan-EU pilot DCT)

Amy Rogers (Lead / Corresponding author), Isla Mackenzie (Lead / Corresponding author), Hawkins Kimberley

Research output: Book/Report › Other report

Abstract

Clinical trials are a crucial step in the development and testing of medical treatments. They are essential to ensure that new treatments are safe and effective.

Traditionally, clinical trials have taken place in hospitals or other research sites, often requiring participants to attend several face-to-face study visits. While these trials produce results, they can do so at a great burden to participants and risk excluding people who are unable or unwilling to travel to study visits.

Remote decentralised clinical trials (RDCTs) are one way to make trials more accessible. RDCTs are centred around participants. Using technology can allow people to take part in clinical trials in their own home with no need to travel to attend study visits or to take substantial time off work or away from family. RDCTs have the potential to make taking part in a clinical trial simple and convenient.

These draft recommendations are based on in-depth research, conducted over a 12-month period, into remote decentralised clinical trial methods. They apply to all aspects of RDCTs from design, planning and set-up to close-out and reporting.

3 Key Recommendations
Answer an important research question
Keep the focus on participants
Simplify the participant experience whilst maintaining quality and scientific rigour

Full recommendations will be published at the end of the IMI Trials@Home project in 2024.

Original language	English
Publisher	Trials@Home
Number of pages	46
Publication status	Published - 26 Aug 2020

Keywords

Clinical trial methodology
Decentralised clinical trials

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

https://trialsathome.com/first-set-of-recommendations-for-rdcts-d1-1/

1 Active

Trials@Home: Center of Excellence – Remote Decentralised Clinical Trials (Joint with 30 other participants, University Medical Centre Utrecht as lead)
MacDonald, T. (Investigator) & Mackenzie, I. (Investigator)
COMMISSION OF THE EUROPEAN COMMUNITIES
1/09/19 → 30/11/25
Project: Research

3 Article
2 Other contribution

A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)
Coyle, J., Rogers, A. (Lead / Corresponding author), Copland, R., De Paoli, G., MacDonald, T. M., Mackenzie, I. S. & Trials@Home Consortium, 30 Jul 2022, In: Trials. 23, 11 p., 614.
Research output: Contribution to journal › Article › peer-review

Open Access
File
10 Citations (Scopus)

63 Downloads (Pure)
A Systematic Review of Methods used to Conduct Decentralised Clinical Trials
Rogers, A. (Lead / Corresponding author), De Paoli, G., Subbarayan, S., Copland, R., Harwood, K., Coyle, J., Mitchell, L., MacDonald, T. M., Mackenzie, I. S. & Trials@Home Consortium, Jun 2022, In: British Journal of Clinical Pharmacology. 88, 6, p. 2843-2862 20 p.
Research output: Contribution to journal › Article › peer-review

Open Access
File
38 Citations (Scopus)

322 Downloads (Pure)
Learning from remote decentralised clinical trial experiences: a qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders
Coyle, J. (Lead / Corresponding author), Rogers, A., Copland, R., De Paoli, G., MacDonald, T. M., Mackenzie, I. S. & Trials@Home Consortium, Mar 2022, In: British Journal of Clinical Pharmacology. 88, 3, p. 1031-1042 12 p.
Research output: Contribution to journal › Article › peer-review

Open Access
File
35 Citations (Scopus)

165 Downloads (Pure)

1 Invited talk

Trials@Home - An Update from the European DCT Perspective.
Rogers, A. (Speaker)
18 Apr 2023 → 20 Apr 2023
Activity: Talk or presentation types › Invited talk

Cite this

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title = "D1.1 First set of recommendations for RDCTs (to be implemented in the pan-EU pilot DCT)",

abstract = "Clinical trials are a crucial step in the development and testing of medical treatments. They are essential to ensure that new treatments are safe and effective.Traditionally, clinical trials have taken place in hospitals or other research sites, often requiring participants to attend several face-to-face study visits. While these trials produce results, they can do so at a great burden to participants and risk excluding people who are unable or unwilling to travel to study visits.Remote decentralised clinical trials (RDCTs) are one way to make trials more accessible. RDCTs are centred around participants. Using technology can allow people to take part in clinical trials in their own home with no need to travel to attend study visits or to take substantial time off work or away from family. RDCTs have the potential to make taking part in a clinical trial simple and convenient.These draft recommendations are based on in-depth research, conducted over a 12-month period, into remote decentralised clinical trial methods. They apply to all aspects of RDCTs from design, planning and set-up to close-out and reporting. 3 Key Recommendations Answer an important research question Keep the focus on participants Simplify the participant experience whilst maintaining quality and scientific rigour Full recommendations will be published at the end of the IMI Trials@Home project in 2024. ",

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AB - Clinical trials are a crucial step in the development and testing of medical treatments. They are essential to ensure that new treatments are safe and effective.Traditionally, clinical trials have taken place in hospitals or other research sites, often requiring participants to attend several face-to-face study visits. While these trials produce results, they can do so at a great burden to participants and risk excluding people who are unable or unwilling to travel to study visits.Remote decentralised clinical trials (RDCTs) are one way to make trials more accessible. RDCTs are centred around participants. Using technology can allow people to take part in clinical trials in their own home with no need to travel to attend study visits or to take substantial time off work or away from family. RDCTs have the potential to make taking part in a clinical trial simple and convenient.These draft recommendations are based on in-depth research, conducted over a 12-month period, into remote decentralised clinical trial methods. They apply to all aspects of RDCTs from design, planning and set-up to close-out and reporting. 3 Key Recommendations Answer an important research question Keep the focus on participants Simplify the participant experience whilst maintaining quality and scientific rigour Full recommendations will be published at the end of the IMI Trials@Home project in 2024.

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PB - Trials@Home

ER -

D1.1 First set of recommendations for RDCTs (to be implemented in the pan-EU pilot DCT)

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Fingerprint

Projects

Trials@Home: Center of Excellence – Remote Decentralised Clinical Trials (Joint with 30 other participants, University Medical Centre Utrecht as lead)

Research output

A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

Learning from remote decentralised clinical trial experiences: a qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders

Activities

Trials@Home - An Update from the European DCT Perspective.

Cite this