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Journal articles on the topic 'Surrogate endpoints'

Author: Grafiati

Published: 4 June 2021

Last updated: 8 February 2022

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1

Banerjee, Buddhananda, and Atanu Biswas. "True endpoint reduction by surrogate endpoints." Communications in Statistics - Simulation and Computation 46, no. 8 (May 27, 2016): 6645–53. http://dx.doi.org/10.1080/03610918.2016.1171350.

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2

Ciani, Oriana, Bogdan Grigore, Hedwig Blommestein, Saskia de Groot, Meilin Möllenkamp, Stefan Rabbe, Rita Daubner-Bendes, and Rod S. Taylor. "Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies." Medical Decision Making 41, no. 4 (March 10, 2021): 439–52. http://dx.doi.org/10.1177/0272989x21994553.

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Background Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA). Objectives 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies. Methods We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. W

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3

Ciani, Oriana, Sarah Davis, Paul Tappenden, Ruth Garside, Ken Stein, Anna Cantrell, Everardo D. Saad, Marc Buyse, and Rod S. Taylor. "VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMORS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS." International Journal of Technology Assessment in Health Care 30, no. 3 (July 2014): 312–24. http://dx.doi.org/10.1017/s0266462314000300.

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Objectives: Licensing of, and coverage decisions on, new therapies should rely on evidence from patient-relevant endpoints such as overall survival (OS). Nevertheless, evidence from surrogate endpoints may also be useful, as it may not only expedite the regulatory approval of new therapies but also inform coverage decisions. It is, therefore, essential that candidate surrogate endpoints be properly validated. However, there is no consensus on statistical methods for such validation and on how the evidence thus derived should be applied by policy makers.Methods: We review current statistical ap

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4

Ellenberg, SS. "Surrogate endpoints." British Journal of Cancer 68, no. 3 (September 1993): 457–59. http://dx.doi.org/10.1038/bjc.1993.369.

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5

Hughes, Michael D. "Evaluating surrogate endpoints." Controlled Clinical Trials 23, no. 6 (December 2002): 703–7. http://dx.doi.org/10.1016/s0197-2456(02)00264-7.

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6

Hahn, Andreas, Andreas Podbielski, Markus M. Heimesaat, Hagen Frickmann, and Philipp Warnke. "Binary surrogate endpoints in clinical trials from the perspective of case definitions." European Journal of Microbiology and Immunology 11, no. 1 (March 30, 2021): 18–22. http://dx.doi.org/10.1556/1886.2020.00031.

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AbstractIntroductionSurrogate endpoints are widely used in clinical trials, especially in situations where the endpoint of interest is not directly observable or to avoid long trial periods. A typical example for this case is frequently found in clinical trials in oncology, where overall survival (OS) as endpoint of interest and progression free survival (PFS) as surrogate endpoint are discriminated.MethodsBased on the perspective of case definitions on surrogate endpoints, we provide a formal definition of such endpoints followed by a description of the structure of surrogate endpoints.Result

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7

Kuller, Lewis H. "Clinical trials: surrogate endpoints or hard endpoints?" American Journal of Cardiology 88, no. 2 (July 2001): 59–61. http://dx.doi.org/10.1016/s0002-9149(01)01786-6.

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8

&NA;. "Biomarkers and Surrogate Endpoints." American Journal of Therapeutics 6, no. 4 (July 1999): 179–80. http://dx.doi.org/10.1097/00045391-199907000-00001.

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9

Somberg, J. "Biomarker and Surrogate Endpoints." American Journal of Therapeutics 10, no. 4 (July 2003): 239–40. http://dx.doi.org/10.1097/00045391-200307000-00001.

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10

Furgerson, James L., William N. Hannah, and Jennifer C. Thompson. "Challenge of Surrogate Endpoints." Southern Medical Journal 105, no. 3 (March 2012): 156–60. http://dx.doi.org/10.1097/smj.0b013e318249891e.

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11

Aronson, J. K. "Biomarkers and surrogate endpoints." British Journal of Clinical Pharmacology 59, no. 5 (May 2005): 491–94. http://dx.doi.org/10.1111/j.1365-2125.2005.02435.x.

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12

Robb, Melissa A., Pamela M. McInnes, and Robert M. Califf. "Biomarkers and Surrogate Endpoints." JAMA 315, no. 11 (March 15, 2016): 1107. http://dx.doi.org/10.1001/jama.2016.2240.

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13

Srivastava, Sudhir, and John A. Wagner. "Surrogate Endpoints in Medicine." Disease Markers 18, no. 2 (2002): 39–40. http://dx.doi.org/10.1155/2002/182186.

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14

Rasnake, Crystal M., Paula R. Trumbo, and Therese M. Heinonen. "Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease." Nutrition Reviews 66, no. 2 (February 4, 2008): 76–81. http://dx.doi.org/10.1111/j.1753-4887.2007.00010.x.

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15

Santosh Kumar, Rada, and Ganesh Sai Myneni. "SURROGATE ENDPOINT: ALTERNATIVE FOR EARLY ASSESSMENT OF A POTENTIAL TREATMENT EFFECT." Journal of Drug Delivery and Therapeutics 9, no. 4-s (August 29, 2019): 819–21. http://dx.doi.org/10.22270/jddt.v9i4-s.3371.

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The efficacy of health technologies, medicines and medical devices should be demonstrated in trails that evaluate final patient-relevant outcomes such as survival or morbidity. We provide a summary of the present use of surrogate end points in health care policy, discussing the case for and against their reviewing and adoption validation methods. Although the use of surrogates can be problematic, they can be validated and selected properly, offers important chances for more efficient clinical trials and faster access to new health technologies that benefit health care systems and patients. In

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16

Dobler, Claudia C., Rebecca L. Morgan, Yngve Falck-Ytter, Victor M. Montori, and M. Hassan Murad. "Assessing the validity of surrogate endpoints in the context of a controversy about the measurement of effectiveness of hepatitis C virus treatment." BMJ Evidence-Based Medicine 23, no. 2 (February 26, 2018): 50–53. http://dx.doi.org/10.1136/bmjebm-2017-110852.

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Surrogate endpoints are often used in clinical trials, as they allow for indirect measures of outcomes (eg, shorter trials with less participants). Improvements in surrogate endpoints (eg, reduction in low density lipoprotein cholesterol, normalisation of glycated haemoglobin) achieved with an intervention are, however, not always associated with improvements in patient-important outcomes. The common tendency in evidence-based medicine is to view results based on surrogate endpoints as less certain than results based on long term, final patient-important outcomes and rate them as ‘lower qualit

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17

Royce, Trevor Joseph, Ming-Hui Chen, Jing Wu, Marian Loffredo, Andrew A. Renshaw, Philip W. Kantoff, and Anthony Victor D'Amico. "A comparison of surrogate endpoints for all cause mortality in men with localized unfavorable-risk prostate cancer." Journal of Clinical Oncology 35, no. 6_suppl (February 20, 2017): 21. http://dx.doi.org/10.1200/jco.2017.35.6_suppl.21.

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21 Background: Several surrogates for prostate cancer-specific mortality exist, but whether these are surrogates for all cause mortality (ACM), and how their performance compares, is unknown. We investigated the relative efficacy of 4 candidate surrogates for ACM using the proportion of treatment effect (PTE) metric. Methods: Two-hundred and six men with localized unfavorable-risk prostate cancer were randomized to radiation therapy (RT) or RT and 6 months of androgen-deprivation therapy (ADT) from 1995 to 2001 and followed for a median of 16.62 years. Among the 159 men with no or minimal como

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18

Weintraub, William S., Thomas F. Lüscher, and Stuart Pocock. "The perils of surrogate endpoints." European Heart Journal 36, no. 33 (May 13, 2015): 2212–18. http://dx.doi.org/10.1093/eurheartj/ehv164.

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19

Fleming, Thomas R. "Surrogate Endpoints in Clinical Trials." Drug Information Journal 30, no. 2 (April 1996): 545–51. http://dx.doi.org/10.1177/009286159603000230.

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20

Van Houwelingen, Hans C. "The Evaluation of Surrogate Endpoints." Biometrics 62, no. 3 (September 2006): 948–49. http://dx.doi.org/10.1111/j.1541-0420.2006.00588_12.x.

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21

Gilbert, Peter B., and Michael G. Hudgens. "Evaluating Candidate Principal Surrogate Endpoints." Biometrics 64, no. 4 (March 24, 2008): 1146–54. http://dx.doi.org/10.1111/j.1541-0420.2008.01014.x.

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22

Wortzel, Hal S., Peter M. Gutierrez, Beeta Y. Homaifar, Ryan E. Breshears, and Jeri E. Harwood. "Surrogate Endpoints in Suicide Research." Suicide and Life-Threatening Behavior 40, no. 5 (October 2010): 500–505. http://dx.doi.org/10.1521/suli.2010.40.5.500.

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23

Gelman, Simon. "Right, Wrong, and Surrogate Endpoints." Anesthesiology 82, no. 4 (April 1995): 1084. http://dx.doi.org/10.1097/00000542-199504000-00035.

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24

Khalil, Samia. "Right, Wrong, and Surrogate Endpoints." Anesthesiology 82, no. 4 (April 1995): 1084. http://dx.doi.org/10.1097/00000542-199504000-00036.

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25

Somberg, John. "Surrogate Endpoints and Drug Approval." American Journal of Therapeutics 13, no. 5 (September 2006): 388. http://dx.doi.org/10.1097/01.mjt.0000244278.30783.81.

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26

Koppman, Aaron F. "Surrogate Endpoints and Neuromuscular Recovery." Anesthesiology 87, no. 5 (November 1, 1997): 1029–31. http://dx.doi.org/10.1097/00000542-199711000-00001.

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27

Mamelok, Richard. "How controversial are surrogate endpoints?" Nature Biotechnology 12, no. 2 (February 1994): 134–35. http://dx.doi.org/10.1038/nbt0294-134.

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28

Friedman, Lawrence, and Salim Yusuf. "Surrogate endpoints in clinical trials." Controlled Clinical Trials 6, no. 3 (September 1985): 222. http://dx.doi.org/10.1016/0197-2456(85)90012-1.

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29

Qureshi, Mahin Iqbal, Matthew C. Cheung, Sierra Cheng, Di Maria Jiang, Erica McDonald, Vanessa Sarah Arciero, Doreen Anuli Ezeife, Alexandra Chambers, Kelley-Anne Sabarre, and Kelvin K. Chan. "Are surrogate endpoints unbiased metrics compared to hazard ratio for death? An evaluation of clinical benefit scores (CBS) in the American Society of Clinical Oncology (ASCO) value framework." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 6600. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.6600.

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6600 Background: Clinical benefit scores (CBS) are a key element of the American Society of Clinical Oncology (ASCO) value framework's Net Health Benefit valuation of cancer therapies. CBS are assigned based on a hierarchy of efficacy endpoints, from hazard ratio for death (HR OS), to median overall survival (mOS), HR for disease progression (HR PFS), median progression-free survival (mPFS), and response rate (RR). When HR OS is unavailable, other endpoints in the hierarchy are used as "surrogates" to calculate CBS via their scaling factors. We aim to examine whether surrogate-derived CBS offe

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30

Feigin, Andrew. "Evidence from biomarkers and surrogate endpoints." NeuroRX 1, no. 3 (July 2004): 323–30. http://dx.doi.org/10.1602/neurorx.1.3.323.

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31

Sikora, Karol. "Surrogate endpoints in cancer drug development." Drug Discovery Today 7, no. 18 (September 2002): 951–56. http://dx.doi.org/10.1016/s1359-6446(02)02434-0.

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32

Xu, Jane, and Scott L. Zeger. "The Evaluation of Multiple Surrogate Endpoints." Biometrics 57, no. 1 (March 2001): 81–87. http://dx.doi.org/10.1111/j.0006-341x.2001.00081.x.

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33

Burzykowski, Tomasz. "Surrogate endpoints: wishful thinking or reality?" Statistical Methods in Medical Research 17, no. 5 (February 19, 2008): 463–66. http://dx.doi.org/10.1177/0962280207081866.

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34

Huang, Ying, and Peter B. Gilbert. "Comparing Biomarkers as Principal Surrogate Endpoints." Biometrics 67, no. 4 (April 22, 2011): 1442–51. http://dx.doi.org/10.1111/j.1541-0420.2011.01603.x.

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35

Daskalakis, C., and E. Shenassa. "Inference about Mediators or Surrogate Endpoints." American Journal of Epidemiology 163, suppl_11 (June 1, 2006): S241. http://dx.doi.org/10.1093/aje/163.suppl_11.s241-b.

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36

Baker, Stuart G. "Surrogate Endpoints: Wishful Thinking or Reality?" JNCI: Journal of the National Cancer Institute 98, no. 8 (April 19, 2006): 502–3. http://dx.doi.org/10.1093/jnci/djj153.

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37

Ellenberg, Susan S., and J. Michael Hamilton. "Surrogate endpoints in clinical trials: Cancer." Statistics in Medicine 8, no. 4 (April 1989): 405–13. http://dx.doi.org/10.1002/sim.4780080404.

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38

Baak, Jan P. A. "Histological surrogate endpoints using quantitative cytometry." Journal of Cellular Biochemistry 53, S17G (1993): 96–97. http://dx.doi.org/10.1002/jcb.240531119.

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39

Hartman, Holly E., and William C. Jackson. "Surrogate Endpoints in Localized Prostate Cancer." Cancer Journal 26, no. 1 (2020): 48–52. http://dx.doi.org/10.1097/ppo.0000000000000422.

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40

Li, Nicole F. "Surrogate Endpoints in Oncology Drug Development." Annals of Oncology 25 (October 2014): v86. http://dx.doi.org/10.1093/annonc/mdu436.53.

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41

Gottlieb, Stephen S. "Surrogate Endpoints: Not the Real Thing." Journal of Cardiac Failure 22, no. 10 (October 2016): 761–62. http://dx.doi.org/10.1016/j.cardfail.2016.07.431.

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42

Berns, B., P. Démolis, and M. E. Scheulen. "How can biomarkers become surrogate endpoints?" European Journal of Cancer Supplements 5, no. 9 (December 2007): 37–40. http://dx.doi.org/10.1016/j.ejcsup.2007.09.003.

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43

Markman, Maurie. "Surrogate Efficacy Endpoints in Oncology Trials." Pharmaceutical Medicine 23, no. 5-6 (October 2009): 283–87. http://dx.doi.org/10.1007/bf03256783.

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44

Feigin, Andrew. "Evidence from biomarkers and surrogate endpoints." Neurotherapeutics 1, no. 3 (July 2004): 323–30. http://dx.doi.org/10.1007/bf03206617.

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45

Biglan, Kevin M., and Robert G. Holloway. "Surrogate endpoints in Parkinson’s disease research." Current Neurology and Neuroscience Reports 3, no. 4 (July 2003): 314–20. http://dx.doi.org/10.1007/s11910-003-0008-y.

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46

Ellenberg, Susan S. "Surrogate endpoints: the debate goes on." Pharmacoepidemiology and Drug Safety 10, no. 6 (October 2001): 493–96. http://dx.doi.org/10.1002/pds.655.

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47

Busch, MP, HA Perkins, P. Holland, and L. Petersen. "The CUE debate (continued): on surrogate tests and surrogate endpoints." Transfusion 31, no. 9 (November 1991): 869–71. http://dx.doi.org/10.1046/j.1537-2995.1991.31992094677.x.

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48

Ying, Jian, Andrew Redd, and Tom Greene. "2091." Journal of Clinical and Translational Science 1, S1 (September 2017): 22–23. http://dx.doi.org/10.1017/cts.2017.92.

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OBJECTIVES/SPECIFIC AIMS: The objective of this research is to determine under what conditions endpoints based on estimated glomerular filtration rate (eGFR) slope or on relatively small declines in eGFR provide valid and useful surrogate endpoints for pivotal clinical trials in chronic kidney disease (CKD) patients. METHODS/STUDY POPULATION: We consider 2 classes of surrogate endpoints. The first class includes endpoints defined by the average rate of change in eGFR during defined portions of the follow-up period of the trial, following initiation of the randomized treatment interventions. Th

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49

Cheng, Sierra, Matthew C. Cheung, Di Maria Jiang, Erica McDonald, Vanessa S. Arciero, Doreen Anuli Ezeife, Amanda Rahmadian, et al. "Are Surrogate Endpoints Unbiased Metrics in Clinical Benefit Scores of the ASCO Value Framework?" Journal of the National Comprehensive Cancer Network 17, no. 12 (December 2019): 1489–96. http://dx.doi.org/10.6004/jnccn.2019.7333.

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Background: Clinical benefit scores (CBS) are key elements of the ASCO Value Framework (ASCO-VF) and are weighted based on a hierarchy of efficacy endpoints: hazard ratio for death (HR OS), median overall survival (mOS), HR for disease progression (HR PFS), median progression-free survival (mPFS), and response rate (RR). When HR OS is unavailable, the other endpoints serve as “surrogates” to calculate CBS. CBS are computed from PFS or RR in 39.6% of randomized controlled trials. This study examined whether surrogate-derived CBS offer unbiased scoring compared with HR OS–derived CBS. Methods: U

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50

Michiels, S., A. Le Maître, M. Buyse, T. Burzykowski, J. Bogaerts, J. B. Vermorken, W. Budach, K. Ang, T. Pajak, and J. P. Pignon. "Surrogate endpoints for overall survival (OS) in head and neck squamous cell carcinoma (HNSCC): Evaluation using individual data of 23,737 patients." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 6035. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6035.

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6035 Background: The gold standard endpoint in randomized trials of HNSCC is OS. Our objective was to study if event-free survival (EFS) or loco-regional control (LRC) could be good surrogate endpoints to estimate the effect of radiotherapy (RT) and chemotherapy (CT) on OS. This would permit to decrease the duration and cost of the development of new treatments for HNSCC. Methods: EFS is the time from randomization to first event (loco-regional, distant recurrence or death), LRC the time from randomization to first loco-regional event. Individual patient data from two meta-analyses (MARCH; Bou

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