Clinical trial NCT06751641: Survey of Adult Participants Enrolled in Decentralized Clinical Trials
Official title: A Longitudinal, Multicenter Survey of Adult Participants Enrolled in Decentralized Clinical Trials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinical Trial Incorporating Decentralized Elements
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population includes adults participating in traditional clinical trials for drugs that could adopt decentralized elements in the future. Eligible participants are patients or healthy volunteers enrolled in interventional trials evaluating one or more drugs, regardless of pathology, receiving treatments at the investigative site and/or their residence.

Examples include participants in trials for injectable drugs administered in hospitals, such as anticancer agents. However, trials with non-translatable procedures, like those involving critically ill patients in intensive care, are excluded. Anyone meeting these criteria is eligible for the DeCTris survey

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Laurent Flet, PharmD
role: PRINCIPAL_INVESTIGATOR
References: