Study identification

PURI

https://redirect.ema.europa.eu/resource/106207

EU PAS number

EUPAS106035

Study ID

106207

Official title and acronym

Comparison of participant characteristics in decentralized clinical trials, conventional clinical trials, and real-world patients: a descriptive study

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Decentralized clinical trial (DCT) approaches have the promise of improving trial representativeness, by improving trial access, allowing the inclusion of immobile participants or participants from rural areas, and lowering the burden of trial participation. Therefore, an eligible participant who would not participate in a conventional trial with regular on-site trial-related procedures may participate in a decentralized trial. Broad representativeness improves the generalizability of the study results, which may benefit regulatory and clinical decision-making. However, it is unclear whether the promise of increased representativeness can be met in practice. This study aims to compare the participant characteristics of those who participated in a fully decentralized trial and a comparable clinical trial to real-world patients who were intended to be treated and those who would have been eligible to participate. To this end, we selected a decentralized and conventional trial that both evaluated the effect of aspirin for the primary prevention of vascular events in patients with diabetes.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Gardarsdottir Helga

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme

More details on funding

IMI Trials@Home
Study protocol
Updated protocol

20240411_Research protocol_ENCEPP_v2.pdf

English (987.19 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable