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/ReportOther 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 languageEnglish
PublisherTrials@Home
Number of pages46
Publication statusPublished - 26 Aug 2020

Keywords

  • Clinical trial methodology
  • Decentralised clinical trials

ASJC Scopus subject areas

  • General Medicine

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