VT-ONE
Research type
Research Study
Full title
The development of a virtual trial; participant’s perception of challenges of implementation and comparison with traditional site-dependent trial methods.
IRAS ID
310544
Contact name
Cho Ee Ng
Contact email
Clinicaltrials.gov Identifier
researchregistry8013, Research Registry
Duration of Study in the UK
0 years, 6 months, 6 days
Research summary
New digital solutions are developed to help patients take part in clinical research. These burdens have previously been shown to affect a patient’s decision to sign up for a study. This can cause poor recruitment in some studies and delay progress in healthcare.
Virtual trials are a type of study that uses these digital solutions and remote connectivity. This enables remote participation in the research study. Moreover, it has the potential to improve accessibility and overcome inequalities in healthcare research.
RELIEVE IBS-D is the UK’s first interventional virtual trial. The study started in 2018 as a site-based trial (ST) and changed to a virtual trial design in 2020. This allowed the study to continue despite COVID-19 pandemic restrictions. These patients could take part and use less time to recruit the number of participants by enabling broader participation.
With the VT-ONE study, we want to understand the consequences of using a virtual trial design. We want to explore the differences in the participant’s experiences when taking part in the research. As well as if this will impact the recruitment and retention during the trial.
VT-ONE study will be a discussion with RELIEVE IBS-D participants to learn about their experiences. They are a unique group with some patients having a traditional clinical trial experience while others had a virtual trial experience. Both groups still experienced the same research study. We want to compare their experiences to find proof of the impact of a virtual trial.
We also plan to compare our findings to published concepts. We want to describe what are the influences of digital innovation in research. The aim will be to determine the consequences for the participants when implementing the virtual trial design and identify digital innovations that can influence participants’ recruitment and retention during research trials.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/PR/0917
Date of REC Opinion
19 Aug 2022
REC opinion
Further Information Favourable Opinion