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Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence

Published online by Cambridge University Press:  01 January 2021

Spencer Phillips Hey ,
William B. Feldman ,
Emily H. Jung ,
Elvira D'Andrea  and
Aaron S. Kesselheim
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Abstract

The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 3: Biomarker Research and Validation: Current Challenges, Future Opportunities , Fall 2019 , pp. 381 - 387
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

Kesselheim, A. S. and Karlawish, J., “Biomarkers Unbound — The Supreme Court's Ruling on Diagnostic-Test Patents,” New England Journal of Medicine 366, no. 25 (2012): 2338-2340.CrossRefGoogle Scholar
Fleming, T. R. and DeMets, D. L., “Surrogate End Points in Clinical Trials: Are We Being Misled?” Annals of Internal Medicine 125, no. 7 (1996): 605-613.CrossRefGoogle Scholar
US Food and Drug Administration, “Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure,” available at <https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm613636.htm> (last visited July 17, 2019).+(last+visited+July+17,+2019).>Google Scholar
Id.Google Scholar
Id.Google Scholar
Korn, E. L., Albert, P. S., and McShane, L. M., “Assessing Surrogates as Trial Endpoints Using Mixed Models,” Statistics in Medicine 24, no. 2 (2005): 163-182.CrossRefGoogle Scholar
Lipska, K. J. and Krumholz, H. M., “Is Hemoglobin A1c the Right Outcome for Studies of Diabetes?” JAMA 317, no. 10 (2017): 1017-1018.CrossRefGoogle Scholar
Reddel, H. K., Taylor, D. R., Bateman, E. D., Boulet, L. P., Boushey, H. A., Busse, W. W., Casale, T. B., Chanez, P., Enright, P. L., Gibson, P. G., and de Jongste, J.C., “An official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations: Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice,” American Journal of Respiratory and Critical Care Medicine 180, no. 1 (2009): 59-99.CrossRefGoogle Scholar
Saldanha, I. J., Dickersin, K., Wang, X., and Li, T., “Outcomes in Cochrane Systematic Reviews Addressing Four Common Eye Conditions: An Evaluation of Completeness and Comparability,” PloS One 9, no. 10 (2014): e109400.CrossRefGoogle Scholar