The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development. Lathia, C., Amakye, D, Dai, W, Girman, C, Madani, S, Mayne, J, MacCarthy, P, Pertel, P, Seman, L, Stoch, A, Tarantino, P, Webster, C, Williams, S, & Wagner, J. Clinical Pharmacology & Therapeutics, 86(1):32-43, 7, 2009. Mesures de resultats; Surrogate endpoints; Regulació; Exemples![The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development [link]](https://bibbase.org/img/filetypes/link.svg "link")
Paper doi abstract bibtex The acceptance and use of either surrogate end points (SEPs) or efficient clinical end points are associated with greater and more rapid availability of new medicines as compared with disease situations for which clinical end points are inefficient or no surrogates exist. This review of the history of the development, qualification, and acceptance of key SEPs shows that both successes and failures had three key characteristics: (i) apparent biologic plausibility, (ii) prognostic value for the outcome of the disease, and (iii) an association between changes in the SEP and changes in outcome with therapeutic intervention–the three factors recommended for SEPs in the International Conference on Harmonisation's "Statistical Principles for Clinical Trials." We recommend that only prognostic value be an absolute prerequisite for surrogacy, because therapeutic interventions may not exist a priori, and biological plausibility can be subjective. Ideally, all three of these factors would be traded off against one another in a consistent and transparent risk-management process.
@article{Lathia2009,
abstract = {The acceptance and use of either surrogate end points (SEPs) or efficient clinical end points are associated with greater and more rapid availability of new medicines as compared with disease situations for which clinical end points are inefficient or no surrogates exist. This review of the history of the development, qualification, and acceptance of key SEPs shows that both successes and failures had three key characteristics: (i) apparent biologic plausibility, (ii) prognostic value for the outcome of the disease, and (iii) an association between changes in the SEP and changes in outcome with therapeutic intervention--the three factors recommended for SEPs in the International Conference on Harmonisation's "Statistical Principles for Clinical Trials." We recommend that only prognostic value be an absolute prerequisite for surrogacy, because therapeutic interventions may not exist a priori, and biological plausibility can be subjective. Ideally, all three of these factors would be traded off against one another in a consistent and transparent risk-management process.},
added-at = {2023-02-03T11:44:35.000+0100},
author = {Lathia, CD and Amakye, D and Dai, W and Girman, C and Madani, S and Mayne, J and MacCarthy, P and Pertel, P and Seman, L and Stoch, A and Tarantino, P and Webster, C and Williams, S and Wagner, JA},
biburl = {https://www.bibsonomy.org/bibtex/21557730b5a6d3f9fd2a1bc4a4a315cb6/jepcastel},
doi = {10.1038/clpt.2009.69},
interhash = {23318dd5b5e783e5719d70b73c5ab1f5},
intrahash = {1557730b5a6d3f9fd2a1bc4a4a315cb6},
issn = {0009-9236},
journal = {Clinical Pharmacology & Therapeutics},
keywords = {imported},
month = {7},
note = {Mesures de resultats; Surrogate endpoints; Regulació; Exemples},
number = 1,
pages = {32-43},
pmid = {19474783},
timestamp = {2023-02-03T11:44:35.000+0100},
title = {The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19474783 http://doi.wiley.com/10.1038/clpt.2009.69},
volume = 86,
year = 2009
}
Downloads: 0
{"_id":"PA9eggXgekNriKBT6","bibbaseid":"lathia-amakye-dai-girman-madani-mayne-maccarthy-pertel-etal-thevaluequalificationandregulatoryuseofsurrogateendpointsindrugdevelopment-2009","author_short":["Lathia, C.","Amakye, D","Dai, W","Girman, C","Madani, S","Mayne, J","MacCarthy, P","Pertel, P","Seman, L","Stoch, A","Tarantino, P","Webster, C","Williams, S","Wagner, J."],"bibdata":{"bibtype":"article","type":"article","abstract":"The acceptance and use of either surrogate end points (SEPs) or efficient clinical end points are associated with greater and more rapid availability of new medicines as compared with disease situations for which clinical end points are inefficient or no surrogates exist. This review of the history of the development, qualification, and acceptance of key SEPs shows that both successes and failures had three key characteristics: (i) apparent biologic plausibility, (ii) prognostic value for the outcome of the disease, and (iii) an association between changes in the SEP and changes in outcome with therapeutic intervention–the three factors recommended for SEPs in the International Conference on Harmonisation's \"Statistical Principles for Clinical Trials.\" We recommend that only prognostic value be an absolute prerequisite for surrogacy, because therapeutic interventions may not exist a priori, and biological plausibility can be subjective. Ideally, all three of these factors would be traded off against one another in a consistent and transparent risk-management process.","added-at":"2023-02-03T11:44:35.000+0100","author":[{"propositions":[],"lastnames":["Lathia"],"firstnames":["CD"],"suffixes":[]},{"propositions":[],"lastnames":["Amakye"],"firstnames":["D"],"suffixes":[]},{"propositions":[],"lastnames":["Dai"],"firstnames":["W"],"suffixes":[]},{"propositions":[],"lastnames":["Girman"],"firstnames":["C"],"suffixes":[]},{"propositions":[],"lastnames":["Madani"],"firstnames":["S"],"suffixes":[]},{"propositions":[],"lastnames":["Mayne"],"firstnames":["J"],"suffixes":[]},{"propositions":[],"lastnames":["MacCarthy"],"firstnames":["P"],"suffixes":[]},{"propositions":[],"lastnames":["Pertel"],"firstnames":["P"],"suffixes":[]},{"propositions":[],"lastnames":["Seman"],"firstnames":["L"],"suffixes":[]},{"propositions":[],"lastnames":["Stoch"],"firstnames":["A"],"suffixes":[]},{"propositions":[],"lastnames":["Tarantino"],"firstnames":["P"],"suffixes":[]},{"propositions":[],"lastnames":["Webster"],"firstnames":["C"],"suffixes":[]},{"propositions":[],"lastnames":["Williams"],"firstnames":["S"],"suffixes":[]},{"propositions":[],"lastnames":["Wagner"],"firstnames":["JA"],"suffixes":[]}],"biburl":"https://www.bibsonomy.org/bibtex/21557730b5a6d3f9fd2a1bc4a4a315cb6/jepcastel","doi":"10.1038/clpt.2009.69","interhash":"23318dd5b5e783e5719d70b73c5ab1f5","intrahash":"1557730b5a6d3f9fd2a1bc4a4a315cb6","issn":"0009-9236","journal":"Clinical Pharmacology & Therapeutics","keywords":"imported","month":"7","note":"Mesures de resultats; Surrogate endpoints; Regulació; Exemples","number":"1","pages":"32-43","pmid":"19474783","timestamp":"2023-02-03T11:44:35.000+0100","title":"The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development","url":"http://www.ncbi.nlm.nih.gov/pubmed/19474783 http://doi.wiley.com/10.1038/clpt.2009.69","volume":"86","year":"2009","bibtex":"@article{Lathia2009,\n abstract = {The acceptance and use of either surrogate end points (SEPs) or efficient clinical end points are associated with greater and more rapid availability of new medicines as compared with disease situations for which clinical end points are inefficient or no surrogates exist. This review of the history of the development, qualification, and acceptance of key SEPs shows that both successes and failures had three key characteristics: (i) apparent biologic plausibility, (ii) prognostic value for the outcome of the disease, and (iii) an association between changes in the SEP and changes in outcome with therapeutic intervention--the three factors recommended for SEPs in the International Conference on Harmonisation's \"Statistical Principles for Clinical Trials.\" We recommend that only prognostic value be an absolute prerequisite for surrogacy, because therapeutic interventions may not exist a priori, and biological plausibility can be subjective. Ideally, all three of these factors would be traded off against one another in a consistent and transparent risk-management process.},\n added-at = {2023-02-03T11:44:35.000+0100},\n author = {Lathia, CD and Amakye, D and Dai, W and Girman, C and Madani, S and Mayne, J and MacCarthy, P and Pertel, P and Seman, L and Stoch, A and Tarantino, P and Webster, C and Williams, S and Wagner, JA},\n biburl = {https://www.bibsonomy.org/bibtex/21557730b5a6d3f9fd2a1bc4a4a315cb6/jepcastel},\n doi = {10.1038/clpt.2009.69},\n interhash = {23318dd5b5e783e5719d70b73c5ab1f5},\n intrahash = {1557730b5a6d3f9fd2a1bc4a4a315cb6},\n issn = {0009-9236},\n journal = {Clinical Pharmacology & Therapeutics},\n keywords = {imported},\n month = {7},\n note = {Mesures de resultats; Surrogate endpoints; Regulació; Exemples},\n number = 1,\n pages = {32-43},\n pmid = {19474783},\n timestamp = {2023-02-03T11:44:35.000+0100},\n title = {The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development},\n url = {http://www.ncbi.nlm.nih.gov/pubmed/19474783 http://doi.wiley.com/10.1038/clpt.2009.69},\n volume = 86,\n year = 2009\n}\n\n","author_short":["Lathia, C.","Amakye, D","Dai, W","Girman, C","Madani, S","Mayne, J","MacCarthy, P","Pertel, P","Seman, L","Stoch, A","Tarantino, P","Webster, C","Williams, S","Wagner, J."],"key":"Lathia2009","id":"Lathia2009","bibbaseid":"lathia-amakye-dai-girman-madani-mayne-maccarthy-pertel-etal-thevaluequalificationandregulatoryuseofsurrogateendpointsindrugdevelopment-2009","role":"author","urls":{"Paper":"http://www.ncbi.nlm.nih.gov/pubmed/19474783 http://doi.wiley.com/10.1038/clpt.2009.69"},"keyword":["imported"],"metadata":{"authorlinks":{}},"html":""},"bibtype":"article","biburl":"http://www.bibsonomy.org/bib/author/williams?items=1000","dataSources":["9yEa5Kjt9P75Q7HKD"],"keywords":["imported"],"search_terms":["value","qualification","regulatory","use","surrogate","end","points","drug","development","lathia","amakye","dai","girman","madani","mayne","maccarthy","pertel","seman","stoch","tarantino","webster","williams","wagner"],"title":"The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development","year":2009}