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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

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Development of Novel, Value-Based, Digital Endpoints for Clinical Trials: A Structured Approach Toward

M D Kruizinga¹, F E Stuurman¹, V Exadaktylos¹

¹Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.).

Pharmacological Reviews

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Summary

Novel digital endpoints offer promise for clinical trials but require clear validation. This paper presents a pragmatic framework for selecting and validating these digital measurements for reliable use.

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Area of Science:

Clinical trial methodology
Digital health technologies
Biomedical informatics

Background:

Novel digital endpoints from wearables and algorithms show potential for clinical trials.
Slow implementation is attributed to a lack of validation guidelines for these new measurements.

Purpose of the Study:

To propose a pragmatic approach for the selection and fit-for-purpose validation of digital endpoints.
To provide criteria for technical and clinical validation of digital measurements in clinical trials.

Main Methods:

Value-based selection focusing on meaningful patient outcomes.
Assessment of technological validity for devices.
Rigorous clinical validation including tolerability, patient-control differences, repeatability, event detection, and correlation with traditional endpoints.

Main Results:

A framework for evaluating digital endpoints based on technological and clinical validity.
Demonstration of how validated digital endpoints can support evidence generation in interventional trials.
Potential for digital endpoints to replace traditional measures like scales and questionnaires.

Conclusions:

Adoption of this pragmatic approach will facilitate timely implementation of digital measurements in clinical trials and healthcare.
Recommendations include increased data-sharing collaborations and integration of value-based measurements into clinical care.
Encourages researchers and regulators to adopt these criteria for advancing digital health in trials and healthcare.