Challenges of Virtual Trials, Data Integrity and Patient Privacy Protection
3:20 PM - 3:40 PM
• Semantic challenges: They aren't "decentralized", they aren't "siteless". Protocol schedules use “visit”, but the term is confusing for remote trials. Such trials are “Remote" and "Virtual". How will medical writers adapt jargon?
• Logistical challenges: Include drawing samples, examining patients, how to comply with safety oversight (e.g. suicidality, Informed consent), site inspections; reminder fatigue, providing trial records for each site; accommodating "site-shifters"
• Compliance: ClinROs (Clinician Reported Outcomes) and patient questionnaires, e.g. joint man.
• Operations: Remote collaboration—There is enhanced relative value of evidence that can be gathered without physical presence: particularly helpful for emergent disease, exploration of symptoms, and for tracking symptom severity as an efficacy endpoint.