Relevant bibliographies by topics / Surrogate endpoints

Academic literature on the topic 'Surrogate endpoints'

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Published: 4 June 2021
Last updated: 8 February 2022

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Journal articles on the topic "Surrogate endpoints"

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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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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. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation. Results Of the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports ( k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60–13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23–2.20; P = 0.55). Conclusions Handling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies.
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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 approaches to surrogate-endpoint validation based on meta-analysis in various advanced-tumor settings. We assessed the suitability of two surrogates (progression-free survival [PFS] and time-to-progression [TTP]) using three current validation frameworks: Elston and Taylor's framework, the German Institute of Quality and Efficiency in Health Care's (IQWiG) framework and the Biomarker-Surrogacy Evaluation Schema (BSES3).Results: A wide variety of statistical methods have been used to assess surrogacy. The strength of the association between the two surrogates and OS was generally low. The level of evidence (observation-level versus treatment-level) available varied considerably by cancer type, by evaluation tools and was not always consistent even within one specific cancer type.Conclusions: Not in all solid tumors the treatment-level association between PFS or TTP and OS has been investigated. According to IQWiG's framework, only PFS achieved acceptable evidence of surrogacy in metastatic colorectal and ovarian cancer treated with cytotoxic agents. Our study emphasizes the challenges of surrogate-endpoint validation and the importance of building consensus on the development of evaluation frameworks.
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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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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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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.ResultsSurrogate endpoints can be considered as case definitions for the endpoint of interest. Therefore, the performance of surrogate endpoints can be described using the classical terminology of diagnostic tests including sensitivity and specificity. Since such endpoints always focus on sensitivity with necessarily reduced specificity, efficacy estimates based on such endpoints are in general biased.ConclusionThe abovementioned has to be taken into account while interpreting the results of clinical trials and should not be ignored while planning or conducting a study.
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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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&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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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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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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Dissertations / Theses on the topic "Surrogate endpoints"

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Feng, Chunyao Seaman John Weldon. "Bayesian evaluation of surrogate endpoints." Waco, Tex. : Baylor University, 2006. http://hdl.handle.net/2104/4187.

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Nordman, Ina IC Clinical School St Vincent's Hospital Faculty of Medicine UNSW. "Surrogate endpoints of survival in metastatic carcinoma." Publisher:University of New South Wales. Clinical School - St Vincent's Hospital, 2008. http://handle.unsw.edu.au/1959.4/42791.

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In most randomised controlled trials (RCTs), a large number of patients need to be followed over many years, for the clinical benefit of the drug to be accurately quantified (1). Using an early proxy, or a surrogate endpoint, in place of the direct endpoint of overall survival (OS) could theoretically shorten the duration of RCTs and minimise the exposure of patients to ineffective or toxic treatments (2, 3). This thesis examined the relationship between surrogate endpoints and OS in metastatic colorectal cancer (CRC), advanced non-small cell lung cancer (NSCLC) and metastatic breast cancer (MBC). A review of the literature identified 144 RCTs in metastatic CRC, 189 in advanced NSCLC and 133 in MBC. The publications were generally of poor quality with incomplete reporting on many key variables, making comparisons between studies difficult. The introduction of the CONSORT statement was associated with improvements in the quality of reporting. For CRC (337 arms), NSCLC (429 arms) and MBC (290 arms) there were strong relationships between OS and progression free survival (PFS), time to progression (TTP), disease control rate (DCR), response rate (RR) and partial response (PR). Correlation was also demonstrated between OS and complete response (CR) in CRC and duration of response (DOR) in MBC. However, while strong relationships were found, the proportion of variance explained by the models was small. Prediction bands constructed to determine the surrogate threshold effect size indicated that large improvements in the surrogate endpoints were needed to predict overall survival gains. PFS and TTP showed the most promise as surrogates. The gain in PFS and TTP required to predict a significant gain in overall survival was between 1.2 and 7.0 months and 1.8 and 7.7 months respectively, depending on trial size and tumour type. DCR was a better potential predictor of OS than RR. The results of this study could be used to design future clinical trials with particular reference to the selection of surrogate endpoint and trial size.
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Wang, Hui. "Response Adaptive Randomization using Surrogate and Primary Endpoints." VCU Scholars Compass, 2016. http://scholarscompass.vcu.edu/etd/4517.

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In recent years, adaptive designs in clinical trials have been attractive due to their efficiency and flexibility. Response adaptive randomization procedures in phase II or III clinical trials are proposed to appeal ethical concerns by skewing the probability of patient assignments based on the responses obtained thus far, so that more patients will be assigned to a superior treatment group. General response-adaptive randomizations usually assume that the primary endpoint can be obtained quickly after the treatment. However, in real clinical trials, the primary outcome is delayed, making it unusable for adaptation. Therefore, we utilize surrogate and primary endpoints simultaneously to adaptively assign subjects between treatment groups for clinical trials with continuous responses. We explore two types of primary endpoints commonly used in clinical tirials: normally distributed outcome and time-to-event outcome. We establish a connection between the surrogate and primary endpoints through a Bayesian model, and then update the allocation ratio based on the accumulated data. Through simulation studies, we find that our proposed response adaptive randomization is more effective in assigning patients to better treatments as compared with equal allocation randomization and standard response adaptive randomization which is solely based on the primary endpoint.
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Bark, Charles. "CLINICAL SYMPTOMS AND MICROBIOLOGICAL OUTCOMES IN TUBERCULOSIS TREATMENT TRIALS." Case Western Reserve University School of Graduate Studies / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=case1307630776.

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Dimier, Natalie. "Statistical methodology for evaluation of time-to-event surrogate and true endpoints in small-sample meta-analysis of clinical trials." Thesis, University of Reading, 2017. http://centaur.reading.ac.uk/78463/.

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Clinical trials can be lengthy and costly, with new treatments taking more than a decade to become available to the patients who need them. It is therefore of great interest to improve efficiency in this process, such as replacing the primary endpoint of a clinical trial with an alternative endpoint that can be measured with greater ease, reduced cost or reduced observation periods. Such replacement endpoints are called surrogate endpoints, and there has been a vast amount of research conducted to establish statistical methodology that can reliably assess whether such endpoints are appropriate for future use. The aims of this research are therefore threefold; to identify appropriate methodology that can be used in the assessment of time-to-event surrogate and true endpoints; to examine the identified methods via simulation studies for the setting of small sample sizes, across a variety of scenarios, and in particular for surrogate endpoints that capture information on both an intermediate disease status and the long-term clinical outcome of interest; and finally to develop improved methodology that can advance the surrogacy evaluation process for these settings. The findings of the research build on the existing surrogate endpoint literature by demonstrating that the most commonly used approaches for evaluation of time-to-event surrogate and true endpoints can have potential limitations. As a result of this finding, and based on the identified strengths and weaknesses of the examined statistical approaches under the settings of interest, a novel methodology for the evaluation of time-to-event surrogate and true endpoints is proposed and evaluated. This method provides an alternative option for the evaluation of surrogate endpoints, and is recommended for further use.
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Savina, Marion. "Critères de Substitution à la Survie Globale dans les Essais Cliniques Randomisés en Cancérologie." Thesis, Bordeaux, 2017. http://www.theses.fr/2017BORD0894/document.

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Dans les essais cliniques randomisés (ECR) en cancérologie, un critère de substitution est une mesure biologique utilisée à la place d’un critère cliniquement pertinent pour le patient, par exemple la survie globale (SG), qui doit permettre de prédire l’effet attendu du traitement. Des critères alternatifs à la SG, par exemple la survie sans progression, sont de plus en plus fréquemment utilisés en tant que critère de jugement principal dans les ECR. En pratique cependant, les capacités de substitution à la SG de ces critères ne sont pas systématiquement évaluées. Nous avons dressé un état des lieux des critères de substitution validés en cancérologie à partir d’une revue systématique de la littérature. Par la suite, nous avons évalué par une approche méta-analytique des critères de substitution dans le contexte des sarcomes des tissus mous en situation avancée et du cancer du sein en situation adjuvante. Les résultats n’ont pas permis de définitivement valider de critères de substitution à la SG dans ces indications. La SG doit donc rester le critère de jugement principal des ECR, même si certains critères alternatifs restent informatifs dans des évaluations plus précoces (phase II, analyse de futilité), sous réserve que les données de survie continuent à être recueillies. Ce travail fournit des informations clés pour le développement des ECR en cancérologie afin notamment de sélectionner au mieux les critères de jugement de l’efficacité thérapeutique
In cancer randomized controlled trials (RCT), a surrogate endpoint is intended to substitute a clinically relevant endpoint, e.g. overall survival (OS), and it is supposed to predict treatment effect. Alternative endpoints, for example progression-free survival, are increasingly being used in place of OS as primary efficacy endpoints in RCTs. In practice however, the surrogate properties of these endpoints are not systematically assessed. We performed a systematic literature review to identify surrogate endpoints validated in oncology. We next conducted MAs to evaluate surrogate endpoints in two cancer settings: advanced soft-tissue sarcoma and adjuvant breast cancer. Results could not definitely validate surrogate endpoints in these indications. OS must remain the primary efficacy endpoint in these settings, even though alternative endpoints may provide valuable input in earlier phase studies (phase II trials, futility analyses). This work provides key information for the design of cancer RCTs, in particular for the choice of primary endpoints to assess treatment efficacy
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Branchoux, Sébastien. "Critères de substitution de la survie globale chez les patients atteints de cancer métastatique traités par inhibiteurs de points de contrôle immunologiques." Thesis, Bordeaux, 2020. http://www.theses.fr/2020BORD0253.

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La prise en charge du cancer au stade avancé ou métastatique a été profondément modifiée avec l’arrivée des inhibiteurs des points de contrôle immunologiques (immune-checkpoint inhibitors (ICI)). Ces anticorps monoclonaux immuno-modulateurs ont été développés pour soit déclencher une nouvelle réponse immunitaire anti-tumorale, soit réactiver une réponse existante pour lutter contre le cancer. L’espérance de vie des patients traités par ce type de thérapie est plus longue par rapport à ceux traités par les thérapies usuelles. Par conséquent, la puissance statistique requise dans un essai clinique randomisé (ECR) ayant pour objectif principal d’estimer l’effet relatif du traitement sur la survie globale (SG), critère de référence en oncologie, peut être difficile à atteindre. Dans ce contexte, il est important d’identifier et de valider des critères de substitution de la SG chez les patients traités par ICI afin notamment de permettre un accès précoce à ces traitements innovants. Nous avons tout d’abord effectué une revue systématique de la littérature des différents critères cliniques intermédiaires associés à la SG chez les patients traités par ICI. Puis, à partir des conclusions de cette revue et de la connaissance de la spécificité du mécanisme d’action des ICI, nous avons évalué les propriétés de substitution d’un nouveau critère, le « temps jusqu’à l’initiation d’un traitement systémique ultérieur » (time to next treatment (TNT)), chez les patients atteints d’un mélanome avancé ou d’un carcinome à cellules rénales avancé, à partir de modèles statistiques récemment développés pour la validation de critères de substitution. D’après les résultats de ces analyses, le TNT semble être un critère de substitution prometteur dans ces 2 populations. Nous encourageons les promoteurs d’ECR d’ICI à recueillir la date d’initiation du traitement systémique ultérieur afin de pouvoir réaliser des analyses similaires de plus grande ampleur et de confirmer ainsi nos résultats
Advanced cancer treatment has been recently revolutionized by the development of the immune-checkpoint inhibitors (ICI). These immunomodulatory monoclonal antibodies are designed to either elicit a novel anti-tumoral immune response or revitalize an existing one to fight against cancer. Patients with cancer are living longer due to these improved therapies. Powering a study for overall survival (OS), the gold standard primary endpoint in randomized controlled trial (RCT) of anticancer drugs is becoming increasingly challenging. Therefore, it is of importance to identify and validate novel surrogate endpoints (SE) for OS in ICI-treated patients for expediting patients’ access to innovative and potentially life extending medicines. We first systematically reviewed published studies reporting on an association between alternative endpoints and OS in ICI-treated patients. Then, based on the learnings from this systematic literature review and from the specificity of the mechanism of action of ICIs, we evaluated the surrogacy properties of an emerging intermediate endpoint in solid tumors, namely time to next treatment (TNT), in ICI-treated patients with advanced melanoma and renal cell carcinoma (aRCC), through recent innovative statistical models for the validation of SE. Based on the results of these surrogacy analyses, TNT seems a promising SE for OS in RCTs of ICI-treated patients with advanced melanoma and aRCC. We encourage sponsors of RCTs of ICI to carefully collect the date of subsequent systemic treatment, so that surrogacy analyses could consequently be performed with a larger number of RCTs in order to confirm our findings
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Sofeu, Casimir. "Développement de méthodes pour la validation de critères de substitution en survie : méta-analyses de cancer." Thesis, Bordeaux, 2019. http://www.theses.fr/2019BORD0383.

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Les critères de substitution peuvent être utilisés à la place du critère de jugement le plus pertinent pour évaluer l'efficacité d'un nouveau traitement. Dans un contexte de méta-analyse, l'approche classique pour la validation d'un critère de substitution est basée sur une stratégie d'analyse en deux étapes. Pour des critères de jugement à temps d’évènements, cette approche est souvent sujette à des problèmes d'estimations. Nous proposons une approche de validation en une étape s'appuyant sur des modèles conjoints à fragilités et à copules. Ces modèles incluent à la fois des effets aléatoires au niveau essai et au niveau individuel ou des fonctions de copule. Nous considérons des fonctions de risque de base non paramétriquesà l'aide des splines. Les paramètres des modèles et les fonctions de risque de base ont été estimés par une méthode semi-paramétrique, par maximisation de la vraisemblance marginale pénalisée, considérant différentes méthodes d'intégration numérique. La validation des critères de substitution à la fois au niveau individuel et au niveau essai a été faite à partir du tau de Kendall et du coefficient de détermination. Les études de simulation ont été faites pour évaluer les performances de nos modèles. Les modèles ont été appliqués aux données individuelles issues des méta-analyses sur le cancer afin de rechercher de potentiels critères de substitution à la survie globale. Les modèles étaient assez robustes avec réduction des problèmes de convergence et d'estimation rencontrés dans l'approche en deux étapes. Nous avons développé un package R convivial implémentant les nouveaux modèles
Surrogate endpoint can be used instead of the most relevant clinical endpointto assess the efficiency of a new treatment. In a meta-analysis framework, the classical approach for the validation of surrogate endpoint is based on a two-step analysis. For failure time endpoints, this approach often raises estimation issues.We propose a one-step validation approach based on a joint frailty and a joint frailty-copula model.The models include both trial-level and individual-level random effects or copula functions. We chose a non-parametric form of the baseline hazard functions using splines. We estimated parameters and hazard functions using a semi-parametric penalized marginal likelihood method, considering various numerical integration methods. Both individual level and trial level surrogacy were evaluated using Kendall's tau and coefficient of determination. The performance of the estimators was evaluated using simulation studies. The models were applied to individual patient data meta-analyses in cancer clinical trials for assesing potentiel surrogate endpoint to overall survival.The models were quite robust with a reduction of convergence and model estimation issues encountered in the two-step approach.We developed a user friendly R package implementing the models
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Qin, Lang. "Magnetic resonance imaging lesion count as a surrogate endpoint in relapsing-remitting multiple sclerosis clinical trials." Thesis, University of British Columbia, 2011. http://hdl.handle.net/2429/37092.

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The count of active lesions based on magnetic resonance imaging (MRI) is often used as a potential surrogate endpoint in phase 2 clinical trials for relapsing-remitting multiple sclerosis (RRMS) patients. However, this surrogacy relationship has not been completely validated. In this report, we study whether at the trial level, the MRI lesion count is a good surrogate endpoint for the relapse rate, the usual clinical endpoint for RRMS clinical trials. Two different approaches to assess this surrogacy relationship are applied to the dataset used by Sormani et al. [1] (SBRCMB) which contains the summary results from 23 randomized, placebo-controlled clinical trials in RRMS. The SBRCMB approach uses simple linear regression with weighted least squares estimation, while our more comprehensive approach develops a detailed model for the endpoints and the treatment effects to take into account estimation errors and the correlated contrasts. Both approaches are based only on the summary results from each clinical trial. The shortcomings of the SBRCMB approach are discussed and the results from the two approaches are compared. Both approaches show that the MRI lesion count is a good surrogate endpoint, while our more comprehensive approach shows a nearly perfect surrogacy relationship. When the estimated surrogacy relationship is used to predict the true treatment effect on the clinical endpoint for the trials in the SBRCBM dataset, the approaches give similar point predictions, but the approximate 95% prediction intervals from the comprehensive approach are generally shorter. In practice, the estimated surrogacy relationship based on the comprehensive approach can give a precise prediction for the true treatment effect on the clinical endpoint if the treatment displays a large effect on the surrogate endpoint, but may otherwise lead to an inconclusive result.
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Munoz, Daniel. "The Effects of Fruit and Vegetable Extracts on Surrogate Endpoint Biomarkers in Curatively Treated Head and Neck Squamous Cell Carcinoma Patients." Scholarly Repository, 2009. http://scholarlyrepository.miami.edu/oa_theses/186.

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Dietary factors have been implicated in the risk of head and neck squamous cell carcinoma (HNSCC). Much interest has been placed upon the effects of suspected chemopreventative agents found in fruit and vegetables associated with low HNSCC risk. However, studies investigating specific uptake of these agents have failed to show positive results. The possibility exists that single chemopreventative agents fail to provide the same beneficial effect as the various compounds found in a fruits and vegetables is examined. Curatively treated head and neck squamous cell carcinoma patients ingested Juice Plus, a F&V extract supplement containing multiple chemopreventative agents, for 12 weeks. Lymphocyte samples of participants were collect pre- and post- treatment and examined in pairs. Despite the study currently still blinded, surrogate endpoint biomarkers were evaluated to observer any modification between pre- and post treatment samples. Although a paired t-test showed no significant difference between pre- and post treatment samples on surrogate endpoint biomarkers, there is a significant difference in population distribution between treatment times signifying a modification of the surrogate endpoint biomarkers. The exact nature of this difference is pending due to the blinded status of the study.
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Books on the topic "Surrogate endpoints"

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Burzykowski, Tomasz, Geert Molenberghs, and Marc Buyse, eds. The Evaluation of Surrogate Endpoints. New York, NY: Springer New York, 2005. http://dx.doi.org/10.1007/b138566.

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Medicine), Roundtable for the Development of Drugs and Vaccines against AIDS (Institute of. Surrogate endpoints in evaluating the effectiveness of drugs against HIV infection and AIDS: September 11-12, 1989 : conference summary. Washington, D.C: National Academy Press, 1990.

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Morganroth, Joel, and E. Neil Moore, eds. Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affecting Antiarrhythmic Heart Failure and Hypolipidemia. Boston, MA: Springer US, 1990. http://dx.doi.org/10.1007/978-1-4613-1505-6.

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Alonso, Ariel. Applied Surrogate Endpoint Evaluation Methods with SAS and R. Boca Raton : CRC Press, 2017.: Chapman and Hall/CRC, 2016. http://dx.doi.org/10.1201/9781315372662.

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Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Institute of Medicine (U.S.). Board on Health Care Services, Institute of Medicine (U.S.). Board on Health Sciences Policy, Institute of Medicine (U.S.). Food and Nutrition Board, and National Academies Press (U.S.), eds. Perspectives on biomarker and surrogate endpoint evaluation: Discussion forum summary. Washington, D.C: National Academies Press, 2011.

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Symposium on New Drugs and Devices (10th 1989 Philadelphia, Pa.). Use and approval of antihypertensive agents and surrogate endpoints for the approval of drugs affecting antiarrhythmic heart failure and hypolipidemia: Proceedings of the Tenth Annual Symposium on New Drugs & Devices, October 31-November 1, 1989. Boston: Kluwer Academic Publishers, 1990.

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Kim, Sang-gyŏm. Saenghwahakchŏk pʻyojija mit taeri kyŏlgwa pyŏnsu ŭi PK/PD modelling chŏgyong e kwanhan yŏnʼgu =: The study for evaluation of PK/PD modeling using biomarker and surrogate endpoint. [Seoul]: Sikpʻum Ŭiyakpʻum Anjŏnchʻŏng, 2007.

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The Evaluation Of Surrogate Endpoints. Springer, 2010.

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Molenberghs, Geert, Marc Buyse, and Tomasz Burzykowski. The Evaluation of Surrogate Endpoints. Springer, 2009.

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Wagner, J. A. Surrogate Endpoints in Medicine (Disease Markers). Ios Pr Inc, 2002.

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Book chapters on the topic "Surrogate endpoints"

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Ekhtiari, Seper, Ryan P. Coughlin, Nicole Simunovic, and Olufemi R. Ayeni. "Surrogate Endpoints." In Evidence-Based Surgery, 85–92. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-05120-4_9.

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Fleming, Thomas R., Victor DeGruttola, and David L. Demets. "Surrogate Endpoints." In Methods and Applications of Statistics in Clinical Trials, 878–86. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2014. http://dx.doi.org/10.1002/9781118596005.ch74.

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Cleophas, Ton J., and Aeilko H. Zwinderman. "Validating Surrogate Endpoints." In Machine Learning in Medicine, 53–64. Dordrecht: Springer Netherlands, 2013. http://dx.doi.org/10.1007/978-94-007-6886-4_7.

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Molenberghs, Geert, Ziv Shkedy, Burzykowski Tomasz, Marc Buyse, Ariel Alonso Abad, and Wim Van der Elst. "Evaluation of Surrogate Endpoints." In Handbook of Statistical Methods for Randomized Controlled Trials, 567–600. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315119694-26.

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Ciccone, Giovannino, and Ileana Baldi. "Surrogate Endpoints of Clinical Benefit." In Imaging Tumor Response to Therapy, 3–14. Milano: Springer Milan, 2012. http://dx.doi.org/10.1007/978-88-470-2613-1_1.

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Shkedy, Ziv, and Franz Torres Barbosa. "Bayesian Evaluation of Surrogate Endpoints." In Statistics for Biology and Health, 253–70. New York, NY: Springer New York, 2005. http://dx.doi.org/10.1007/0-387-27080-9_15.

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Paoletti, Xavier, Federico Rotolo, and Stefan Michiels. "Assessing the Value of Surrogate Endpoints." In Textbook of Clinical Trials in Oncology, 425–46. Boca Raton, Florida : CRC Press, [2019]: Chapman and Hall/CRC, 2019. http://dx.doi.org/10.1201/9781315112084-20.

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George, Stephen L. "Surrogate Endpoints in Cancer Clinical Trials." In Statistical Models in Epidemiology, the Environment, and Clinical Trials, 251–72. New York, NY: Springer New York, 2000. http://dx.doi.org/10.1007/978-1-4612-1284-3_8.

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Cleophas, Ton J., and Aeilko H. Zwinderman. "Validating Surrogate Endpoints of Clinical Trials." In Statistics Applied to Clinical Studies, 569–78. Dordrecht: Springer Netherlands, 2011. http://dx.doi.org/10.1007/978-94-007-2863-9_52.

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Passiglia, Francesco, Giuseppe Cicero, Marta Castiglia, and Viviana Bazan. "Biomarkers as Prognostic, Predictive, and Surrogate Endpoints." In Current Clinical Pathology, 31–41. New York, NY: Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2047-1_4.

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Conference papers on the topic "Surrogate endpoints"

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Coxson, Harvey O., Michael L. Watkins, Nicholas W. Locantore, Peter M. Calverley, Bartolome Celli, and Victor M. Pinto-Plata. "Computed Tomography And Associations To Lung Mechanics The Evaluation Of COPD Longitudinally To Identify Predictive Surrogate Endpoints (ECLIPSE) Study." In American Thoracic Society 2010 International Conference, May 14-19, 2010 • New Orleans. American Thoracic Society, 2010. http://dx.doi.org/10.1164/ajrccm-conference.2010.181.1_meetingabstracts.a5136.

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Coxson, HO, HA Gietema, PS Bakke, SS Sharma, and LD Edwards. "Contributions of Airway Wall Thickening and Emphysema to Airflow Limitation: ”Evaluation of COPD Longitudinally To Identify Predictive Surrogate Endpoints” (ECLIPSE) Study." In American Thoracic Society 2009 International Conference, May 15-20, 2009 • San Diego, California. American Thoracic Society, 2009. http://dx.doi.org/10.1164/ajrccm-conference.2009.179.1_meetingabstracts.a6200.

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Anzueto, A., JA Wedzicha, JR Hurst, J. Vestbo, J. Yates, R. Tal-Singer, and DP Miller. "Diagnosis of COPD Exacerbations and Their Distribution Based on GOLD Severity Stages. Data from the Evaluation of COPD Longitudinally To Identify Predictive Surrogate Endpoints (ECLIPSE) Study." In American Thoracic Society 2009 International Conference, May 15-20, 2009 • San Diego, California. American Thoracic Society, 2009. http://dx.doi.org/10.1164/ajrccm-conference.2009.179.1_meetingabstracts.a1527.

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Coxson, Harvey O., Lisa Edwards, Per Bakke, Edwin K. Silverman, William MacNee, and &. ECLIPSE Investigators. "Relationship Between Lung Volumes And The Extent Of Emphysema As Assessed By Computed Tomography In The "Evaluation Of COPD Longitudinally To Identify Predictive Surrogate Endpoints" (ECLIPSE) Study." In American Thoracic Society 2011 International Conference, May 13-18, 2011 • Denver Colorado. American Thoracic Society, 2011. http://dx.doi.org/10.1164/ajrccm-conference.2011.183.1_meetingabstracts.a5781.

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Maselli, Diego J., Hana Müllerova, Nicholas W. Locantore, Jorgen Vestbo, John R. Hurst, Jadwiga A. Wedzicha, and Antonio Anzueto. "Risk Factors And Mortality Associated With Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Exacerbations During The 3-Year Follow-Up In The Evaluation Of COPD Longitudinally To Identify Predictive Surrogate Endpoints (Eclipse) Cohort." In American Thoracic Society 2011 International Conference, May 13-18, 2011 • Denver Colorado. American Thoracic Society, 2011. http://dx.doi.org/10.1164/ajrccm-conference.2011.183.1_meetingabstracts.a5374.

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Fuhlbrigge, A. L., T. W. Harrison, M. Fagerås, A. Jauhiainen, L. E. J. M. Scheepers, J. Zangrilli, and C. A. Da Silva. "An Investigation of Geographic Influence on CompEx, a Surrogate Endpoint for Severe Asthma Exacerbations." In American Thoracic Society 2019 International Conference, May 17-22, 2019 - Dallas, TX. American Thoracic Society, 2019. http://dx.doi.org/10.1164/ajrccm-conference.2019.199.1_meetingabstracts.a1298.

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Heckman-Stoddard, B., RA Lubet, AM Bode, and CJ Grubbs. "P3-11-07: Mammary Gland Biopsy To Examine Surrogate Endpoint Biomarkers of Preventive Agent Efficacy." In Abstracts: Thirty-Fourth Annual CTRC‐AACR San Antonio Breast Cancer Symposium‐‐ Dec 6‐10, 2011; San Antonio, TX. American Association for Cancer Research, 2011. http://dx.doi.org/10.1158/0008-5472.sabcs11-p3-11-07.

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Gabler, Nicole B., Benjamin French, Brian L. Strom, Harold I. Palevsky, Darren Taichman, Steven M. Kawut, and Scott D. Halpern. "Validation Of Six-Minute-Walk Distance As A Surrogate Endpoint In Pulmonary Arterial Hypertension Trials." In American Thoracic Society 2012 International Conference, May 18-23, 2012 • San Francisco, California. American Thoracic Society, 2012. http://dx.doi.org/10.1164/ajrccm-conference.2012.185.1_meetingabstracts.a4092.

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Harris, Wayne B., Dana C. Nickleach, Yuan Liu, Omer Kucuk, and Viraj A. Master. "Abstract C15: Inflammation-free survival as a surrogate endpoint for overall survival in patients with metastatic renal cell carcinoma." In Abstracts: Sixth AACR Conference: The Science of Cancer Health Disparities; December 6–9, 2013; Atlanta, GA. American Association for Cancer Research, 2014. http://dx.doi.org/10.1158/1538-7755.disp13-c15.

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Stamp, L., M. Morillon, W. Taylor, N. Dalbeth, J. Singh, and R. Christensen. "OP0267 Serum urate as a surrogate endpoint for gout flares: results of a systematic review and meta-regression analysis of randomized trials." In Annual European Congress of Rheumatology, 14–17 June, 2017. BMJ Publishing Group Ltd and European League Against Rheumatism, 2017. http://dx.doi.org/10.1136/annrheumdis-2017-eular.1544.

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