Clinical Trial Incorporating Decentralized Elements
Conditions
Brief summary
Clinical trials (CTs) have become increasingly complex, requiring significant commitment from participants. Decentralized clinical trials (DCTs) offer an alternative by shifting some activities away from traditional sites to locations like the patient's home. This reduces the burden on participants, improves accessibility, and enhances recruitment and retention rates. DCTs leverage digital tools such as telemedicine, electronic consent, and wearable devices for data collection. These methods enable fewer site visits, lowering costs and integrating trials more seamlessly into participants' daily routines. This survey aims to assess the willingness of participants already enrolled in traditional CTs to engage in DCTs. Their prior experience with trial procedures allows them to provide valuable insights into the perceived benefits and feasibility of decentralized elements.
Detailed description
The purpose of this survey is to assess the interest of adults enrolled in a traditional interventional clinical trial involving a drug in participating in a clinical trial incorporating decentralized elements.
Interventions
OTHERpatient participating in a clinical trial incorporating decentralized elements.
participating in a clinical trial incorporating decentralized elements.
Sponsors
Nantes University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Adults. Patients or healthy volunteers, ambulatory, enrolled in an interventional clinical trial evaluating a drug and receiving the trial treatment(s) either at the investigative site and/or at their place of residence.
Exclusion criteria
Individuals who have not expressed their non-opposition to participating in the survey. Individuals participating in a clinical trial with procedures that are not deemed translatable to decentralized procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the willingness of adults already enrolled in an interventional clinical trial involving a drug to participate in a similar trial that incorporates one or more decentralized elements. | 1 day | DCT Disposition, is an ordinal variable derived from the DeCTRis self-questionnaire. This scale has five levels, with higher scores indicating a greater willingness to participate in a Decentralized Clinical Trial (DCT). The minimum score is 1, representing the lowest willingness, while the maximum score is 5, indicating the highest willingness to participate in a DCT. |
Countries
France
Contacts
Primary ContactLaurent Flet, Pharm D
Backup ContactAlexandra Poinas
Outcome results
None listed