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Journal articles on the topic 'Survival endpoints'

Author: Grafiati
Published: 4 June 2021
Last updated: 9 March 2023

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1

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 (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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2

Snapinn, Steven M. "Survival Analysis with Uncertain Endpoints." Biometrics 54, no. 1 (1998): 209. http://dx.doi.org/10.2307/2534008.

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3

Overall, John E., and Robert S. Atlas. "Survival analysis with unreliable endpoints." Journal of Psychiatric Research 31, no. 3 (1997): 383–92. http://dx.doi.org/10.1016/s0022-3956(97)00005-8.

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4

Bauer, Peter. "Survival Endpoints and Adaptive Designs." Biometrical Journal 48, no. 4 (2006): 730–31. http://dx.doi.org/10.1002/bimj.200610245.

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5

Mushtaq, Muhammad Umair, Moazzam Shahzad, Ezza Tariq, et al. "Use of Endpoints in Phase III Randomized Controlled Trials for Hematopoietic Stem Cell Transplantation over the Last 15 Years: A Systematic Review." Blood 138, Supplement 1 (2021): 4910. http://dx.doi.org/10.1182/blood-2021-146218.

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Abstract Background: The use of objective endpoints is critical for the generalization and clinical implications of a study. Overall survival (OS) has traditionally been used as the gold standard for demonstrating the true clinical benefit of a therapy or intervention. Use of clinically meaningful pre-specified endpoints is essential for a successful clinical trial. In this systemic review, we aimed to investigate different primary and secondary endpoints used in phase III randomized controlled trials (RCTs) for hematopoietic stem cell transplantation (HCT), and their trends over a span of 15
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6

Edelmann, Dominic, Manuela Hummel, Thomas Hielscher, Maral Saadati, and Axel Benner. "Marginal variable screening for survival endpoints." Biometrical Journal 62, no. 3 (2019): 610–26. http://dx.doi.org/10.1002/bimj.201800269.

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7

Shafrin, Jason, Ron Brookmeyer, Desi Peneva, et al. "How well do surrogate endpoints and overall survival endpoints in clinical trials predict real-world survival?" Journal of Clinical Oncology 33, no. 15_suppl (2015): 6574. http://dx.doi.org/10.1200/jco.2015.33.15_suppl.6574.

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8

Buyse, M. E., K. J. Punt, C. H. Köhne, et al. "Endpoints in adjuvant trials: A systematic review of the literature in colon cancer and proposed definitions for future trials." Journal of Clinical Oncology 25, no. 18_suppl (2007): 4018. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.4018.

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4018 Background: Disease-free survival (DFS) is the primary endpoint of most trials testing adjuvant treatments. However many other endpoints are used. There is much confusion about these endpoints since different definitions were used among trials, or no definitions were provided at all. Moreover there is no consensus on either the definition of each endpoint or on the most relevant among these endpoints. This creates difficulties when comparing the results of various trials. Methods: Adjuvant trials in colon cancer were used as a model. A systematic review was performed on published adjuvant
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9

Gharzai, Laila A., Ralph Jiang, Elizabeth Jaworski, et al. "Candidate surrogate endpoints in advanced prostate cancer: Aggregate meta-analysis of 143 randomized trials." Journal of Clinical Oncology 40, no. 16_suppl (2022): 5039. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.5039.

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5039 Background: The Intermediate Clinical Endpoints (ICEs) in Cancer of the Prostate (ICECaP) working group identified metastasis-free survival as a valid surrogate endpoint for overall survival (OS) for patients with localized prostate cancer. No comparably validated surrogate endpoints for OS exist in advanced prostate cancer. Methods: In this meta-analysis, PubMed was searched for trials in advanced prostate cancer, defined as node positive (N1M0), metastatic castration-sensitive (mCSPC), non-metastatic (M0CRPC), or metastatic castration-resistant prostate cancer (mCRPC). Eligible randomiz
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10

Masson-Lecomte, Alexandra, Victoire Vaillant, Mathieu Roumiguié, et al. "Oncological Outcomes of Distal Ureterectomy for High-Risk Urothelial Carcinoma: A Multicenter Study by The French Bladder Cancer Committee." Cancers 14, no. 21 (2022): 5452. http://dx.doi.org/10.3390/cancers14215452.

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Upper urinary tract urothelial carcinoma (UTUC) is an uncommon disease and its gold-standard treatment is radical nephroureterectomy (RNU). Distal ureterectomy (DU) might be an alternative for tumors of the distal ureter but its indications remain unclear. Here, we aimed to evaluate the oncological outcomes of DU for UTUC of the pelvic ureter. We performed a multicenter retrospective analysis of patients with UTUC who underwent DU. The primary endpoint was 5-year cancer-specific survival (CSS), followed by overall survival (OS), intravesical recurrence-free (IVR) and homolateral urinary tract
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11

Diao, Guoqing, Jun Dong, Donglin Zeng, Chunlei Ke, Alan Rong, and Joseph G. Ibrahim. "Biomarker threshold adaptive designs for survival endpoints." Journal of Biopharmaceutical Statistics 28, no. 6 (2018): 1038–54. http://dx.doi.org/10.1080/10543406.2018.1434191.

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12

Lawrence, John. "Designing Group Sequential Trials with Survival Endpoints." Drug Information Journal 36, no. 1 (2002): 9–15. http://dx.doi.org/10.1177/009286150203600104.

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13

Shahzad, Moazzam, Muhammad Arslan, Sibgha Gull Chaudhary, et al. "Use of Endpoints in Phase III Randomized Controlled Trials for Acute Myeloid Leukemia over the Last 15 Years: A Systematic Review." Blood 138, Supplement 1 (2021): 4389. http://dx.doi.org/10.1182/blood-2021-145545.

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Abstract Background: The use of objective endpoints is critical for the generalization and clinical implications of a study. Overall survival (OS) has traditionally been used as the gold standard for demonstrating the true clinical benefit of therapy or intervention. We systematically evaluated the proportion of different primary and secondary endpoints used in phase III randomized controlled trials (RCTs) for acute myeloid leukemia (AML), and their trends over time. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, a comprehensive l
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14

Schmidt, Rene. "INSP-04. Confirmatory adaptive designs for survival trials with several time-to-event endpoints." Neuro-Oncology 24, Supplement_1 (2022): i187. http://dx.doi.org/10.1093/neuonc/noac079.700.

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Abstract Confirmatory adaptive designs comprise a range of statistical methods that allow to modify the sample size of an ongoing trial in a data-dependent way without compromising control of the type I error rate. For short-term endpoints (e.g., 3-month response rate), comprehensive methodology of adaptive designs exists. However, clinical trials in oncology often have a special focus on long-term outcome and therefore often choose a time-to-event endpoint as the primary endpoint. Typical examples are progression-free survival (PFS) or overall survival (OS). But subtle statistical problems ar
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Narayanan, Siva, Dong Shao, Anshul Shah, and Vidya Ramesh. "Use of intermediate clinical endpoints (ICE) as a primary efficacy endpoint in malignant melanoma." Journal of Clinical Oncology 35, no. 15_suppl (2017): e21075-e21075. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e21075.

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e21075 Background: Melanoma incidence in the US has seen a considerable increase, from 17.8 (1997) to 24.0 (2013) per 100,000, with localized melanoma accounting for 84% of all cases. Early detection and treatment can improve outcomes considerably, resulting in a 99% survival rate. The FDA, within its accelerated approval program, accepts ICE as a primary endpoint, shortening time for patient access to life saving medications. Our objective was to study use of ICE as a primary endpoint for therapies targeting non-metastatic/early-stage malignant melanoma. Methods: A systematic review was condu
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16

Ozols, R. F. "Treatment goals in ovarian cancer." International Journal of Gynecologic Cancer 15, Suppl 1 (2005): 3–11. http://dx.doi.org/10.1136/ijgc-00009577-200505001-00002.

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Ovarian cancer remains the number one gynecological killer in the Western world. Most ovarian cancer patients present with advanced-stage disease and are treated with cytoreductive surgery followed by combination chemotherapy. While the majority of patients respond to treatment, most will relapse such that the 5-year survival rates for advanced disease are approximately 20–25%. Overall survival and progression-free survival (PFS) are the primary endpoints in clinical trials in patients with advanced ovarian cancer. In patients with early-stage ovarian cancer, PFS may be the preferred trial end
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17

Emura, Takeshi, Casimir Ledoux Sofeu, and Virginie Rondeau. "Conditional copula models for correlated survival endpoints: Individual patient data meta-analysis of randomized controlled trials." Statistical Methods in Medical Research 30, no. 12 (2021): 2634–50. http://dx.doi.org/10.1177/09622802211046390.

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Correlations among survival endpoints are important for exploring surrogate endpoints of the true endpoint. With a valid surrogate endpoint tightly correlated with the true endpoint, the efficacy of a new drug/treatment can be measurable on it. However, the existing methods for measuring correlation between two endpoints impose an invalid assumption: correlation structure is constant across different treatment arms. In this article, we reconsider the definition of Kendall's concordance measure (tau) in the context of individual patient data meta-analyses of randomized controlled trials. Accord
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18

Carlson, Robert H. "Stronger correlation of surrogate endpoints with survival needed." Lancet Oncology 17, no. 7 (2016): e273. http://dx.doi.org/10.1016/s1470-2045(16)30210-8.

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19

Zhu, Andrew X. "Abstract IA14: Lessons learned from phase III trials in HCC: OS, PFS and ORR." Clinical Cancer Research 28, no. 17_Supplement (2022): IA14. http://dx.doi.org/10.1158/1557-3265.liverca22-ia14.

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Abstract Through well conducted phase III trials, recent development of molecularly targeted agents, immune checkpoint inhibitors, and combination strategies in advanced hepatocellular carcinoma (HCC) has significantly improved the treatment outcome in this disease. The median overall survival (OS) for patients receiving the new standard treatment, atezolizumab plus bevacizumab, has approached to 20 months in IMbrave150 trial. While OS remains the gold standard and main endpoint for phase III trials in advanced HCC, there is an increasing need to define surrogate endpoints including progressio
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20

Le Tourneau, C., S. Michiels, H. Gan, and L. Siu. "Reporting of endpoints and tracking of failures in randomized trials of radiotherapy or concurrent chemoradiotherapy for locally advanced head and neck squamous cell cancer (LA-HNSCC)." Journal of Clinical Oncology 27, no. 15_suppl (2009): 6072. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6072.

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6072 Background: Due to their anatomical complexity, the interactive effects of multiple treatment modalities, the difficulties in differentiating scar tissues versus residual disease and second cancers versus tumor recurrence, LA-HNSCC represent a challenging disease for the reporting of endpoints and the tracking of failures. Methods: We retrieved all randomized trials that began accrual on or after 1978, and enrolled previously untreated nonmetastatic HNSCC patients receiving primary (chemo)radiotherapy. The reporting of endpoints and the tracking of failures in these trials were analyzed.
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21

Mathoulin-Pelissier, S., S. Gourgou-Bourgade, F. Bonnetain, and A. Kramar. "Quality of reports related to survival events in randomized clinical trials: A review of recent cancer trials published in eight major journals." Journal of Clinical Oncology 25, no. 18_suppl (2007): 6611. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6611.

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6611 Background: About ten years ago, Altman pointed the low quality of survival analyses published in cancer journals. Despite the development of Consort statement, the lack of quality standards remained in the reports of randomized clinical trials (RCT).The aim of this study was to evaluate quality of definitions and reports of survival endpoints in recent cancer RCTs. Methods: A computerized search in Medline databases identified 274 cancer RCTs published from January 2004 to December 2004 in 4 general medical journals (BMJ, JAMA, Lancet, NEJM) and 4 clinical oncology journals (BJC, Cancer,
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22

Heller, Glenn, Robert Thomas Mccormack, Thian Kheoh, et al. "Circulating tumor cell (CTC) number as a response endpoint in metastatic castration resistant (mCRPC) compared with PSA across five randomized phase 3 trials." Journal of Clinical Oncology 35, no. 15_suppl (2017): 5007. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.5007.

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5007 Background: Radiographic progression and overall survival (OS) are the traditional clinical benefit measures for mCRPC trials. Reliable indicators of response that occur early are a critical unmet need in practice and clinical research. We explored a week 13 CTC and prostate-specific antigen (PSA) endpoint relative to baseline in 5 prospective randomized phase 3 registration trials that enrolled 5912 pts. OS was the primary endpoint. Methods: CTC number (CellSearch) and PSA values in patients who survived at least 13 weeks were evaluated as response endpoints in COU-AA-301, AFFIRM, ELM-PC
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23

Topkan, Erkan, Yurday Ozdemir, Ahmet Kucuk, et al. "Low Advanced Lung Cancer Inflammation Index Predicts Poor Prognosis in Locally Advanced Nasopharyngeal Carcinoma Patients Treated with Definitive Concurrent Chemoradiotherapy." Journal of Oncology 2020 (October 6, 2020): 1–10. http://dx.doi.org/10.1155/2020/3127275.

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Purpose. We aimed to retrospectively investigate the prognostic worth of pretreatment advanced lung cancer inflammation index (ALI) in locally advanced nasopharyngeal carcinoma (LA-NPC) patients treated with concurrent chemoradiotherapy (C-CRT). Patients and Methods. A total of 164 LA-NPC patients treated with cisplatinum-based definitive C-CRT were included in this retrospective cohort analysis. The convenience of ideal pre-C-CRT ALI cut-offs affecting survival results was searched by employing the receiver operating characteristic (ROC) curve analyses. The primary endpoint was the link betwe
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24

Sorrell, Lexy, Yinghui Wei, Małgorzata Wojtyś, and Peter Rowe. "Estimating the correlation between semi‐competing risk survival endpoints." Biometrical Journal 64, no. 1 (2021): 131–45. http://dx.doi.org/10.1002/bimj.202000226.

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25

Boelens, Jaap Jan. "Towards new long-term composite ‘Quality of Survival’ endpoints." Bone Marrow Transplantation 55, no. 10 (2020): 1898–99. http://dx.doi.org/10.1038/s41409-020-0883-8.

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26

Dongsheng, Tu, Benny Zee, and Joseph Pater. "Duration projection for equivalence clinical trials with survival endpoints." Controlled Clinical Trials 19, no. 3 (1998): S78. http://dx.doi.org/10.1016/s0197-2456(98)80189-x.

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27

Jóźwiak, Katarzyna, and Mirjam Moerbeek. "Power Analysis for Trials With Discrete-Time Survival Endpoints." Journal of Educational and Behavioral Statistics 37, no. 5 (2012): 630–54. http://dx.doi.org/10.3102/1076998611424876.

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28

WILLIAMS, PAIGE L. "SEQUENTIAL MONITORING OF CLINICAL TRIALS WITH MULTIPLE SURVIVAL ENDPOINTS." Statistics in Medicine 15, no. 21 (1996): 2341–57. http://dx.doi.org/10.1002/(sici)1097-0258(19961115)15:21<2341::aid-sim453>3.0.co;2-n.

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29

Candida Fratazzi and Jixiao Niu. "Accelerated orphan drug approval: surrogate endpoints." World Journal of Advanced Pharmaceutical and Medical Research 2, no. 1 (2022): 001–7. http://dx.doi.org/10.53346/wjapmr.2022.2.1.0021.

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Today, orphan drug development is confronted with significant challenges represented by the considerable complexity, diversity of clinical manifestations, and competition in study recruitment. Thus, surrogate endpoints adoption plays a crucial role in rare disease trials by minimizing costs, the number of subjects, and study duration. Surrogate endpoints, to substitute for a direct measure of how patients feel, function, or survive, must be biomarkers that directly correlate with disease clinical manifestations and predict the impact of study drug on the long-term disease progression. Validati
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30

Weiss, Emmanuel, Jean-Ralph Zahar, Jeff Alder, et al. "Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials." Clinical Infectious Diseases 69, no. 11 (2019): 1912–18. http://dx.doi.org/10.1093/cid/ciz093.

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Abstract Background Randomized clinical trials (RCTs) in hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP, respectively) are important for the evaluation of new antimicrobials. However, the heterogeneity in endpoints used in RCTs evaluating treatment of HABP/VABP may puzzle clinicians. The aim of this work was to reach a consensus on clinical endpoints to consider in future clinical trials evaluating antimicrobial treatment efficacy for HABP/VABP. Methods Twenty-six international experts from intensive care, infectious diseases, and the pharmaceutical industry wer
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31

Oulhaj, Abderrahim, Anouar El Ghouch, and Rury R. Holman. "Testing for qualitative heterogeneity: An application to composite endpoints in survival analysis." Statistical Methods in Medical Research 28, no. 1 (2017): 151–69. http://dx.doi.org/10.1177/0962280217717761.

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Composite endpoints are frequently used in clinical outcome trials to provide more endpoints, thereby increasing statistical power. A key requirement for a composite endpoint to be meaningful is the absence of the so-called qualitative heterogeneity to ensure a valid overall interpretation of any treatment effect identified. Qualitative heterogeneity occurs when individual components of a composite endpoint exhibit differences in the direction of a treatment effect. In this paper, we develop a general statistical method to test for qualitative heterogeneity, that is to test whether a given set
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32

Lee, Linda M., Lisa Wang, and Michael Crump. "Identification of Potential Surrogate Endpoints in Randomized Clinical Trials of Aggressive Non-Hodgkin Lymphoma: Correlation of Complete Response, Time-to-Event and Overall Survival Data." Blood 114, no. 22 (2009): 3699. http://dx.doi.org/10.1182/blood.v114.22.3699.3699.

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Abstract Abstract 3699 Poster Board III-635 Background Aggressive histology non-Hodgkin lymphomas (NHLs) are generally treated with curative intent. Establishing appropriate surrogate endpoints for overall survival (OS) may permit more rapid evaluation and approval of new agents for aggressive NHL. Treatment failure endpoints including event-free survival (EFS) or progression-free survival (PFS) permit earlier reporting of results, but their ability to predict OS is unknown. The purpose of this study is to correlate different efficacy endpoints with the goal of identifying an appropriate surro
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33

Hammel, Pascal, Ewa Carrier, Mairead Carney, Mark Eisner, and Thomas Fleming. "A novel event-free survival endpoint in locally advanced pancreatic cancer." Therapeutic Advances in Medical Oncology 13 (January 2021): 175883592110595. http://dx.doi.org/10.1177/17588359211059586.

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The treatment paradigm for locally advanced pancreatic cancer (LAPC) is evolving rapidly. The development of neoadjuvant therapies composed of combination therapies and the evaluation of their impact on conversion to borderline resectable (BR) status, resection, and ultimately overall survival (OS) are presently being pursued. These efforts justify re-visiting study endpoints in order to better predict therapeutic effects on OS, by capturing not only the achievement of R0 resection at the end of induction therapy but also the long-term reductions in the rate of local and distal recurrence. The
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34

Foster, N. R., Y. Qi, J. E. Krook, et al. "Comparison of progression-free survival (PFS) and tumor response as endpoints for predicting overall survival (OS) in untreated extensive-stage small cell lung cancer (ED-SCLC): Findings based on North Central Cancer Treatment Group (NCCTG) trials." Journal of Clinical Oncology 27, no. 15_suppl (2009): 8085. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.8085.

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8085 Background: Historically, tumor response has been the primary endpoint in phase II (P2) trials in ED-SCLC. We investigated the suitability of alternate PFS based endpoints to predict OS as early evidence of efficacy in the P2 setting. Methods: Individual patient (pt) data from 942 pts from 11 previously untreated ED-SCLC P2 and phase III (P3) platinum- or paclitaxel-based treatment trials were pooled. Best response (BR), response confirmed (RC), objective status at 16 weeks (RR16), and PFS rate at 5 and 6 months were considered. Percent agreement (PA) and kappa (k) for PFS5, PFS6, BR, RC,
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35

Tatla, Raman, Denis Landaverde, Charles Victor, David Miles, and Sunil Verma. "A review of clinical endpoints and use of quality-of-life outcomes in phase III metastatic breast cancer clinical trials." Journal of Clinical Oncology 30, no. 27_suppl (2012): 129. http://dx.doi.org/10.1200/jco.2012.30.27_suppl.129.

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129 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with most interventions intended to relieve disease symptoms, minimize treatment effects and prolong patient survival. The impact of disease and treatment on a patient's funcitonal abilities has led to an emphasis of incorporating quality of life (QoL) measures into clinical trials. The main objective of this study is to evaluate phase III clinical trials in MBC, and assess the inclusion of QOL as an endpoint, in addition to conventional efficacy endpoints. Methods: A structured PubMed search
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36

Flak, Rasmus V., Rune V. Fisker, Niels H. Bruun, Mogens T. Stender, Ole Thorlacius-Ussing, and Lars J. Petersen. "Usefulness of Imaging Response Assessment after Irreversible Electroporation of Localized Pancreatic Cancer—Results from a Prospective Cohort." Cancers 13, no. 12 (2021): 2862. http://dx.doi.org/10.3390/cancers13122862.

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(1) Background: Irreversible electroporation (IRE) is a nonthermal ablation technique that is being studied in nonmetastatic pancreatic cancer (PC). Most published studies use imaging outcomes as an efficacy endpoint, but imaging interpretation can be difficult and has yet to be correlated with survival. The aim of this study was to examine the correlation of imaging endpoints with survival in a cohort of IRE-treated PC patients. (2) Methods: Several imaging endpoints were examined before and after IRE on 18F-fluorodeoxyglucose positron emission tomography (PET) with computed tomography. Separ
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Doolub, N., RFD Dacosta, A. Grosvenor, GD Wang, and R. Macaulay. "P52 Surrogate Survival Endpoints: Are They Sufficient to Support Access?" Value in Health 25, no. 1 (2022): S12. http://dx.doi.org/10.1016/j.jval.2021.11.050.

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38

Jin, Brian, Dingxin Wang, Robert J. Lewandowski, et al. "Chemoembolization Endpoints: Effect on Survival Among Patients With Hepatocellular Carcinoma." American Journal of Roentgenology 196, no. 4 (2011): 919–28. http://dx.doi.org/10.2214/ajr.10.4770.

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39

Flandre, Philippe, and John O'Quigley. "A Two-Stage Procedure for Survival Studies with Surrogate Endpoints." Biometrics 51, no. 3 (1995): 969. http://dx.doi.org/10.2307/2532997.

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40

Walker, Stephen. "A Nonparametric Approach to a Survival Study with Surrogate Endpoints." Biometrics 54, no. 2 (1998): 662. http://dx.doi.org/10.2307/3109772.

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41

Gerds, Thomas A., and Michael Vogeler. "Endpoints and survival analysis for successful osseointegration of dental implants." Statistical Methods in Medical Research 14, no. 6 (2005): 579–90. http://dx.doi.org/10.1191/0962280205sm420oa.

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Jóźwiak, Katarzyna, and Mirjam Moerbeek. "Accrual by groups in trials with discrete-time survival endpoints." Clinical Trials: Journal of the Society for Clinical Trials 10, no. 1 (2012): 32–42. http://dx.doi.org/10.1177/1740774512464831.

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43

Shih, Joanna H. "Sample size calculation for complex clinical trials with survival endpoints." Controlled Clinical Trials 16, no. 6 (1995): 395–407. http://dx.doi.org/10.1016/s0197-2456(95)00132-8.

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Jóźwiak, Katarzyna, and Mirjam Moerbeek. "Cost-effective designs for trials with discrete-time survival endpoints." Computational Statistics & Data Analysis 56, no. 6 (2012): 2086–96. http://dx.doi.org/10.1016/j.csda.2011.12.018.

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Liu, Ping-Yu, and Steve Dahlberg. "Design and analysis of multiarm clinical trials with survival endpoints." Controlled Clinical Trials 16, no. 2 (1995): 119–30. http://dx.doi.org/10.1016/0197-2456(94)00030-7.

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46

Lonial, S., and K. C. Anderson. "Association of response endpoints with survival outcomes in multiple myeloma." Leukemia 28, no. 2 (2013): 258–68. http://dx.doi.org/10.1038/leu.2013.220.

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47

Johnson, Peter, Wolfgang Greiner, Imad Al-Dakkak, and Samuel Wagner. "Which Metrics Are Appropriate to Describe the Value of New Cancer Therapies?" BioMed Research International 2015 (2015): 1–9. http://dx.doi.org/10.1155/2015/865101.

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Patients with certain cancers are treated with curative intent, but for others the results are less favorable and different therapeutic approaches are needed. Early data suggest that new therapies, which modulate immune responses to cancers, may have potential for long-term survival in a proportion of cases. Therefore, it is timely to consider whether metrics generally used to describe the medical value of therapies for patients with common solid tumors remain appropriate for therapies with curative potential. Literature reviews were conducted to define how various stakeholders describe cure i
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48

Poad, Heather, Sam Khan, Lorna Wheaton, Anne Thomas, Michael Sweeting, and Sylwia Bujkiewicz. "The Validity of Surrogate Endpoints in Sub Groups of Metastatic Colorectal Cancer Patients Defined by Treatment Class and KRAS Status." Cancers 14, no. 21 (2022): 5391. http://dx.doi.org/10.3390/cancers14215391.

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Background and Aim: Findings from the literature suggest that the validity of surrogate endpoints in metastatic colorectal cancer (mCRC) may depend on a treatments’ mechanism of action. We explore this and the impact of Kirsten rat sarcoma (KRAS) status on surrogacy patterns in mCRC. Methods: A systematic review was undertaken to identify randomized controlled trials (RCTs) for pharmacological therapies in mCRC. Bayesian meta-analytic methods for surrogate endpoint evaluation were used to evaluate surrogate relationships across all RCTs, by KRAS status and treatment class. Surrogate endpoints
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Khader, Shameer, Youyi Zhang, Daniel Jackson, et al. "663 Correlation between early endpoints and overall survival in non-small-cell lung cancer: a trial-level meta-analysis." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (2020): A700. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0663.

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BackgroundIn clinical trials that assess novel therapeutic agents in patients with non-small-cell lung cancer (NSCLC), early endpoints (e.g. progression-free survival [PFS] and objective response rate) are often evaluated as indicators of biological drug activity, and are used as surrogate endpoints for overall survival (OS). Compiling trial-level data could help to develop a predictive framework to ascertain correlation trends between treatment effects for early (e.g. odds ratio [OR] for PFS at 6 months) and late endpoints (e.g. hazard ratio [HR] OS).MethodsA dataset was compiled, which inclu
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Bonnetain, Franck, Adelaide Doussau, Simone Mathoulin-Pelissier, et al. "International experts’ panel for the development of guidelines for the definition of time to event endpoints in clinical trials (DATECAN project): Results for pancreatic cancer." Journal of Clinical Oncology 30, no. 15_suppl (2012): 4053. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.4053.

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4053 Background: Variability in the definition of survival endpoints in oncology trials was identified (Mathoulin et al.JCO 2008). Lack of a formal consensus could cause this, which limits inter-trial comparisons. The DATECAN project aimed at obtaining a formal consensus recommendation for defining survival endpoints for randomized clinical trials (RCTs) in the following cancer sites: pancreas, sarcoma/GISTs, breast, colorectal, gastric/œsophagus, head and neck, kidney-bladder. We report results for pancreatic cancer. Methods: Based on a literature review of RCTs (2006-2009), we identified sur
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