Review ArticleReview Article
Development of Novel, Value-Based, Digital Endpoints for Clinical Trials: A Structured Approach Toward Fit-for-Purpose Validation
M. D. Kruizinga, F. E. Stuurman, V. Exadaktylos, R. J. Doll, D. T. Stephenson, G. J. Groeneveld, G. J. A. Driessen and A. F. Cohen
Martin Michel, ASSOCIATE EDITOR
Pharmacological Reviews October 2020, 72 (4) 899-909; DOI: https://doi.org/10.1124/pr.120.000028
M. D. Kruizinga
Centre 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.)
F. E. Stuurman
Centre 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.)
V. Exadaktylos
Centre 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.)
R. J. Doll
Centre 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.)
D. T. Stephenson
Centre 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.)
G. J. Groeneveld
Centre 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.)
G. J. A. Driessen
Centre 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.)
A. F. Cohen
Centre 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.)
Martin Michel
Roles: ASSOCIATE EDITOR

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In this issue
Review ArticleReview Article
Fit-for-Purpose Validation of Novel Digital Endpoints
M. D. Kruizinga, F. E. Stuurman, V. Exadaktylos, R. J. Doll, D. T. Stephenson, G. J. Groeneveld, G. J. A. Driessen and A. F. Cohen
Pharmacological Reviews October 1, 2020, 72 (4) 899-909; DOI: https://doi.org/10.1124/pr.120.000028
Review ArticleReview Article
Fit-for-Purpose Validation of Novel Digital Endpoints
M. D. Kruizinga, F. E. Stuurman, V. Exadaktylos, R. J. Doll, D. T. Stephenson, G. J. Groeneveld, G. J. A. Driessen and A. F. Cohen
Pharmacological Reviews October 1, 2020, 72 (4) 899-909; DOI: https://doi.org/10.1124/pr.120.000028
Jump to section
- Article
- Visual Overview
- Abstract
- I. Introduction
- II. Potential Advantages of Value-Based Digital Endpoints
- III. Selection of Candidate Digital Endpoints
- IV. Technical Validation
- V. Clinical Validation
- VI. Case Building
- VII. Discussion
- VIII. Conclusion
- Acknowledgments
- Authorship Contributions
- Footnotes
- Abbreviations
- References
- Figures & Data
- Info & Metrics
- eLetters
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