Key Decentralized Clinical Trial Terms
Bring Your Own Device (BYOD) – Also called bring your own technology, bring your own phone, and bring your own personal computer —refers to being allowed to use one’s personally owned device, rather than being required to use an officially provided device. BYOD is an important part of the approach to DCTs.
Decentralized Clinical Trial (DCT) – Decentralized trials, also known as hybrid trials, virtual(ized) clinical trials, remote trials, and direct-to-patient trials, employ a method of conducting clinical trials where parts or all of the trial happen outside a traditional physical clinic or trial site. Example elements of a DCT include the use of apps or websites for telemedicine, to provide information, to gain consent, and to report symptoms. DCT can also include mobile health units, home care and monitoring, and therapies or medication shipped directly to patients. Any trial procedures that don’t require a visit to the trial site are part of a DCT.
Direct-to-Patient (DtP) services – Brings investigational medicinal products directly to a patient’s home, bypassing the need for the patient to travel directly to a site.
Electronic Consent (eConsent) – Electronic consent (eConsent) is used in lieu of traditional paper and wet signatures gathered at a site and enables patients to learn about their studies through an educational video,followed by written details and guidelines.
Electronic Clinical Outcome Assessment (eCOA) – Measures and records how a patient is feeling or functioning. It is used as part of a clinical trial to measure the efficacy of a health intervention.
Electronic Data Capture (EDC) is a computerized system designed for the collection of clinical data in electronic format for use mainly in clinical trials. EDC replaces the former paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.
Electronic Medical Records (EMRs) are a digital version of the paper charts in the clinician’s office. An EMR typically contains the medical and treatment history of the patients in one practice.
Electronic Patient-Reported Outcome (ePRO) – Electronic patient-reported outcomes (ePRO) in a clinical trial allow patients to answer questions and report on their health through an electronic device, such as a smartphone or tablet.
Patient Centricity – Outcome analysis based on patient’s perspective, measuring patient’s wellness and quality of life and not just reversal of disease or extension of longevity.
Remote Monitoring – Monitoring of specific and often high-risk clinical trial activities performed by the monitor at a location that is removed from the investigative site. Remote monitoring is often used in combination with reduced source data verification (SDV) and reduced source document review (SDR).
Virtual Trial – Also known as decentralized clinical trial (DCT).