What Is A Virtual Approach?
The virtual/decentralized approach advocates the use of new technologies in an integrated, patient-centered approach, allowing patients to participate in clinical trials from the comfort of their homes.
Thanks to various digital tools, the different stages of a virtual clinical trial are conducted entirely or partially (hybrid approach) at a distance, while offering the participant the possibility of having direct contact in real time with the research team.
These tools actively engage participants and give them access to greater autonomy and flexibility, as well as allow for increased communication about the disease, the treatments being studied, and the stages of the clinical trial.
For research teams, these tools allow access to a larger number of participants, especially those dispersed throughout the country and suffering from rare diseases or those who cannot travel to a research site.
Benefits Of A Virtual Clinical Trial Conducted With These Tools:
| For Participants: | For The Research Team: |
|---|---|
|
Access to a greater number of studies |
Access to a larger pool of
potential participants |
|
Decreased travel (and associated stress, costs and risks) |
Access to more diverse populations (remote areas, rare diseases, etc.) |
|
Participation according to participant’s schedule in a comfortable environment (at home) |
Simplified monitoring and data collection |
|
Facilitate family member/caregiver participation |
Access to continuous data through wearable medical devices and digital sensors |
|
Greater participant involvement and autonomy |
Improved participant engagement and retention in the study |
|
Additional sources of information and support in a variety of formats (videos, images, animations, etc.) |
Reduced recruitment time and duration of trials |
|
Reduced dependency on the site staff through the use of digital tools |
Reduced clinical trial costs |
Conventional, Virtual or Hybrid?
There are several approaches to conducting clinical trials.
- Conventional: takes place in person at the research site.
- Virtual/decentralized: takes place remotely, no travel to the research site.
- Hybrid: takes place both at the research site and remotely.
100% On Site
- Recruitment at clinical sites
- Paper consent signed at clinical sites
- In-person visits at clinical sites: screening (validation of eligibility), recruitment and follow-up visits
- Distribution of study medication at clinical sites
- Samples and data collected at clinical sites
- Paper questionnaires completed at clinical sites with a research professional
100% Virtual/Decentralized
- Recruitment website: Participants pre-register online for the study (based on pre-eligibility)
- Electronic referencing by doctors
- Electronic consent
- Remote visits: screening, recruitment and follow-up visits by videoconferencing and/or phone calls with a research professional
- At home delivery of study medication and sample collection kits
- At home collection of samples and data: e.g. self-collection, home research professionals, digital medical devices and sensors
- Online questionnaires completed by the participant: electronic forms
The location of research procedures (e.g., recruitment, consent, follow-up visits, data collection) is based on the needs and capabilities of the study and the participants.