Can Clinical Trial Assessments Be Conducted Remotely?

For selected clinician-administered assessments, yes. Remote delivery by video or telephone can reduce participant burden, improve access, and support hybrid clinical-trial designs. But it is not a simple change of venue. Sponsors need to determine whether the assessment remains valid and meaningful when it is conducted remotely, and apply the right rater training, calibration, and data-quality oversight.

Originally published in International Clinical Trials, this expert article examines when clinician-administered outcome assessments, known as ClinROs, may be suitable for remote delivery. It explores the evidence for structured psychiatric and neurological scales, practical adaptations for assessments that do not transfer directly to video or telephone, and options for site raters, central raters, and central scorers.

What you'll learn

• When video- or telephone-based clinical trial assessments may be appropriate
• Which types of assessments may need modified scoring, item omissions, or an in-person alternative
• Why changing from in-person to remote administration should be treated as a measurement change that requires evidence
• How site raters, central raters, and central scorers can support remote and hybrid trial designs
• How rater training, calibration, recording review, and statistical monitoring help maintain consistent assessment quality
• How FDA guidance on clinical trials with decentralized elements supports telehealth as a mechanism for remote trial activities

Authors

• Bill Byrom, PhD, Vice President, Product Intelligence and Positioning, Signant Health
• Marcela Roy, MA, Executive Director, Clinical Science and Medicine, Signant Health
• Rachel Berman, PhD, Signant Health