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Surrogate endpoint

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https://www.readbyqxmd.com/read/28623775/cancer-immunotherapy-opportunities-and-challenges-in-the-rapidly-evolving-clinical-landscape
#1
REVIEW
Leisha A Emens, Paolo A Ascierto, Phillip K Darcy, Sandra Demaria, Alexander M M Eggermont, William L Redmond, Barbara Seliger, Francesco M Marincola
Cancer immunotherapy is now established as a powerful way to treat cancer. The recent clinical success of immune checkpoint blockade (antagonists of CTLA-4, PD-1 and PD-L1) highlights both the universal power of treating the immune system across tumour types and the unique features of cancer immunotherapy. Immune-related adverse events, atypical clinical response patterns, durable responses, and clear overall survival benefit distinguish cancer immunotherapy from cytotoxic cancer therapy. Combination immunotherapies that transform non-responders to responders are under rapid development...
June 14, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28620783/advanced-neuroimaging-of-cerebral-small-vessel-disease
#2
REVIEW
Gordon W Blair, Maria Valdez Hernandez, Michael J Thrippleton, Fergus N Doubal, Joanna M Wardlaw
Cerebral small vessel disease (SVD) is characterised by damage to deep grey and white matter structures of the brain and is responsible for a diverse range of clinical problems that include stroke and dementia. In this review, we describe advances in neuroimaging published since January 2015, mainly with magnetic resonance imaging (MRI), that, in general, are improving quantification, observation and investigation of SVD focussing on three areas: quantifying the total SVD burden, imaging brain microstructural integrity and imaging vascular malfunction...
July 2017: Current Treatment Options in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28611537/therapeutic-advances-and-new-directions-for-triple-negative-breast-cancer
#3
REVIEW
Eleni Andreopoulou, Catherine M Kelly, Hayley M McDaid
Triple-negative breast cancer (TNBC) is a molecularly diverse grouping with poor prognosis for which chemotherapy remains the foundation of treatment. The molecular heterogeneity of the disease rationalizes its diverse biological behavior and differential response to treatment. Estimates of up to 20% of patients diagnosed have germline mutations in DNA-damage repair-pathway genes, namely BRCA1 and 2, and this can be used to select patients likely to respond to platinums and/or inhibitors of poly(ADP-ribose) polymerase (PARP)...
March 2017: Breast Care
https://www.readbyqxmd.com/read/28597754/characteristics-of-pediatric-pulmonary-hypertension-trials-registered-on-clinicaltrials-gov
#4
Jordan D Awerbach, Richard A Krasuski, Kevin D Hill
The investigation of pediatric pulmonary hypertension (PH) drugs has been identified as a high priority by the United States National Institutes of Health (NIH). Studying pediatric PH is challenging due to the rare and heterogeneous nature of the disease. We sought to define the pediatric PH clinical trials landscape, to evaluate areas of trial success or failure, and to identify potential obstacles to the study of pediatric PH drugs. Interventional pediatric (ages 0-17 years) PH trials registered on ClinicalTrials...
April 2017: Pulmonary Circulation
https://www.readbyqxmd.com/read/28592276/different-strategies-for-mechanical-ventilation-during-cardiopulmonary-bypass-cpbvent-2014-study-protocol-for-a-randomized-controlled-trial
#5
Elena Bignami, Marcello Guarnieri, Francesco Saglietti, Enivarco Massimo Maglioni, Sabino Scolletta, Stefano Romagnoli, Stefano De Paulis, Gianluca Paternoster, Cinzia Trumello, Roberta Meroni, Antonio Scognamiglio, Alessandro Maria Budillon, Vincenzo Pota, Alberto Zangrillo, Ottavio Alfieri
BACKGROUND: There is no consensus on which lung-protective strategies should be used in cardiac surgery patients. Sparse and small randomized clinical and animal trials suggest that maintaining mechanical ventilation during cardiopulmonary bypass is protective on the lungs. Unfortunately, such evidence is weak as it comes from surrogate and minor clinical endpoints mainly limited to elective coronary surgery. According to the available data in the academic literature, an unquestionable standardized strategy of lung protection during cardiopulmonary bypass cannot be recommended...
June 7, 2017: Trials
https://www.readbyqxmd.com/read/28590293/pediatric-pulmonary-arterial-hypertension-on-the-eve-of-growing-up
#6
Johannes M Douwes, Rolf M F Berger
PURPOSE OF REVIEW: Current recommendations for diagnosis and treatment of pulmonary arterial hypertension (PAH) during childhood are expert opinion based, because of lacking pediatric data. In recent years, however, important pediatric data have emerged on PAH. RECENT FINDINGS: PAH in children shows similarities as well as differences compared to adults. Neonates and children know specific clinical presentations and a hemodynamic profile that differs from adults with PAH...
June 5, 2017: Current Opinion in Pulmonary Medicine
https://www.readbyqxmd.com/read/28571299/patient-centered-outcomes-in-periodontal-treatment-an-evidenced-based-approach
#7
REVIEW
Ekta Bharatbhai Shah, Bhavesh Bhupendrabhai Modi, Monali Amit Shah, Deepak Harishbhai Dave
Transformation of research into clinical practice is the most challenging step in evidence based dental practice. Designing the most reliable research with applicable endpoint evaluation is very important as it can lead to successful research outcomes that can be accepted in clinical practice. In the periodontal research few accepted endpoints are used frequently as they are believed to be the gold standard in measuring the periodontal disease and the treatment outcomes. However, a wide range of endpoints used are surrogate endpoints and these endpoints have no direct correlation with the patient centered outcomes...
April 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28567400/secondary-endpoints-surrogate-interest-or-supplementary-table
#8
EDITORIAL
Luca Gianotti, Marta Sandini
No abstract text is available yet for this article.
May 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28557956/-model-for-early-allograft-function-outperforms-early-allograft-dysfunction-as-a-predictor-of-transplant-survival
#9
Ina Jochmans, Steffen Fieuws, Diethard Monbaliu, Jacques Pirenne
BACKGROUND: The Model of Early Allograft Function (MEAF) grades the severity of liver graft dysfunction. Unlike the categorical Early Allograft Dysfunction (EAD) classification, MEAF is a continuous score, based on bilirubin, international normalised ratio, and alanine aminotransferase within 3 days posttransplant. METHODS: Multivariable regression models were used to validate the MEAF score in 660 liver-only transplants performed between 2000-2014. MEAF performance for prediction of transplant survival was compared with that of EAD in univariable and multivariable models by means of Harrell's c-indices, integrated discrimination improvement, and net reclassification improvement...
May 27, 2017: Transplantation
https://www.readbyqxmd.com/read/28555109/rethinking-the-appraisal-and-approval-of-drugs-for-fracture-prevention
#10
Juan Erviti, Javier Gorricho, Luis C Saiz, Thomas Perry, James M Wright
Background: In January 2014, the EMA's Pharmacovigilance Risk Assessment Committee recommended that strontium ranelate no longer be used for osteoporosis. However, EMA's Committee for Medicinal Products for Human Use decided to restrict its use rather than ban it. Starting from this fact, evidence of drugs for fracture prevention over the last 30 years was reviewed and lessons to be learnt from this story are highlighted. Findings: The general belief that drug therapy may become a "solution" for fragility fractures is challenged...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28548626/correlates-of-protection-for-inactivated-enterovirus-71-vaccine-the-analysis-of-immunological-surrogate-endpoints
#11
Wenbo Zhu, Pengfei Jin, Jing-Xin Li, Feng-Cai Zhu, Pei Liu
BACKGROUND: Inactivated Enterovirus 71 (EV71) vaccines showed significant efficacy against the diseases associated with EV71 and a neutralizing antibody (NTAb) titer of 1:16-1:32 was suggested as the correlates of the vaccine protection. This paper aims to further estimate the immunological surrogate endpoints for the protection of inactivated EV71 vaccines and the effect factors. METHODS: Pre-vaccination NTAb against EV71 at baseline (day 0), post-vaccination NTAb against EV71 at day 56, and the occurrence of laboratory-confirmed EV71-associated diseases during a 24-months follow-up period were collected from a phase 3 efficacy trial of an inactivated EV71 vaccine...
June 12, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28544622/an-investigation-into-the-two-stage-meta-analytic-copula-modelling-approach-for-evaluating-time-to-event-surrogate-endpoints-which-comprise-of-one-or-more-events-of-interest
#12
Natalie Dimier, Susan Todd
Clinical trials of experimental treatments must be designed with primary endpoints that directly measure clinical benefit for patients. In many disease areas, the recognised gold standard primary endpoint can take many years to mature, leading to challenges in the conduct and quality of clinical studies. There is increasing interest in using shorter-term surrogate endpoints as substitutes for costly long-term clinical trial endpoints; such surrogates need to be selected according to biological plausibility, as well as the ability to reliably predict the unobserved treatment effect on the long-term endpoint...
May 19, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28537565/surrogate-and-clinical-endpoints-for-studies-in-peripheral-artery-occlusive-disease-are-statistics-the-brakes
#13
Matthias W Waliszewski, Ulf Redlich, Victor Breul, Jörg Tautenhahn
BACKGROUND: The aim of this review is to present the available clinical and surrogate endpoints that may be used in future studies performed in patients with peripheral artery occlusive disease (PAOD). Importantly, we describe statistical limitations of the most commonly used endpoints and offer some guidance with respect to study design for a given sample size. The proposed endpoints may be used in studies using surgical or interventional revascularization and/or drug treatments. METHODS: Considering recently published study endpoints and designs, the usefulness of these endpoints for reimbursement is evaluated...
April 30, 2017: Polski Przeglad Chirurgiczny
https://www.readbyqxmd.com/read/28531261/age-of-acquiring-causal-human-papillomavirus-hpv-infections-leveraging-simulation-models-to-explore-the-natural-history-of-hpv-induced-cervical-cancer
#14
Emily A Burger, Jane J Kim, Stephen Sy, Philip E Castle
Background.: Although new human papillomavirus (HPV) infections can occur at all ages, the age at which women acquire their "causal" HPV infection that develops into cervical cancer is poorly understood and practically unobservable. We aimed to estimate the age distribution at which individuals acquired their causal HPV infection in the absence of HPV vaccination or screening to help guide the optimal use of both. Methods.: Using an empirically calibrated mathematical model that simulates the natural history of cervical cancer, we estimated the cumulative number of causal HPV infections by age, stratified by HPV genotype (HPV16 vs...
May 20, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28529147/norursodeoxycholic-acid-improves-cholestasis-in-primary-sclerosing-cholangitis
#15
Peter Fickert, Gideon M Hirschfield, Gerald Denk, Hanns-Ulrich Marschall, Istvan Altorjay, Martti Färkkilä, Christoph Schramm, Ulrich Spengler, Roger Chapman, Annika Bergquist, Erik Schrumpf, Frederik Nevens, Palak Trivedi, Florian P Reiter, Istvan Tornai, Emina Halilbasic, Roland Greinwald, Markus Pröls, Michael P Manns, Michael Trauner
Primary sclerosing cholangitis (PSC) represents a devastating bile duct disease lacking effective medical therapy. 24-norursodeoxycholic acid (norUDCA) is a side chain-shortened C23 homologue of UDCA and has shown potent anti-cholestatic, anti-inflammatory and anti-fibrotic properties in a preclinical PSC mouse model. AIM: To evaluate the safety and efficacy of 3 doses of oral norUDCA (500mg/d, 1000mg/d or 1500 mg/d) compared with placebo in PSC in a RCT including 38centers from 12European countries...
May 18, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28525561/decade-long-profile-of-imaging-biomarker-use-in-ophthalmic-clinical-trials
#16
Edoardo Villani, Domenico Massaro, Matteo Scaramuzzi, Pedram Hamrah, Felipe A Medeiros, Paolo Nucci
Purpose: The purpose of this study was to investigate the use of imaging biomarkers in published clinical trials (CTs) in ophthalmology and its eventual changes during the past 10 years. Methods: We sampled from published CTs in the fields of cornea, retina, and glaucoma between 2005-2006 and 2015-2016. Data collected included year of publication, phase, subspecialty, location, compliance with Consolidated Standards for Reporting Trials, impact factor, presence and use of imaging biomarkers (diagnostic, prognostic and predictive; primary and secondary surrogate endpoints), and use of centralized reading centers...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28525388/association-between-body-mass-index-and-presence-of-carotid-plaque-among-low-income-adults-aged-45-years-and-older-a-population-based-cross-sectional-study-in-rural-china
#17
Yongzhong Lou, Bin Li, Lan Su, Zhenhong Mu, Minghao Sun, Hongfei Gu, Jingxian Ni, Yanan Wu, Jun Tu, Jinghua Wang, Xianjia Ning
Carotid plaque is a good surrogate endpoint for assessing arterial atherosclerosis, and atherosclerosis is a reliable predictor of cardiovascular diseases. However, the effect of body mass index on carotid plaque is unknown. Therefore, we aimed to explore the association between body mass index and carotid plaque in a low-income Chinese population. Residents aged ≥45 years and free of stroke and cardiovascular diseases were enrolled and divided into four groups based on body mass index. B-mode ultrasonography was performed to measure carotid plaque...
May 4, 2017: Oncotarget
https://www.readbyqxmd.com/read/28524743/nanoparticle-exposures-from-nano-enabled-toner-based-printing-equipment-and-human-health-state-of-science-and-future-research-needs
#18
Sandra Vanessa Pirela, John Martin, Dhimiter Bello, Philip Demokritou
Toner formulations used by laser printers (LP) and photocopiers (PC), collectively called "toner-based printing equipment" (TPE), are nano-enabled products (NEP) because they contain several engineered nanomaterials (ENM) that improve toner performance. It has been shown that during consumer use (printing), these ENM are released in the air, together with other semi-volatile organic nanoparticles, and newly formed gaseous co-pollutants such as volatile organic compounds (VOC). The aim of this review is to detail and analyze physico-chemical and morphological (PCM), as well as the toxicological properties of particulate matter (PM) emissions from TPE...
May 19, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28515862/guidelines-for-collection-and-processing-of-lungs-from-aged-mice-for-histological-studies
#19
John Morton, Timothy A Snider
Pulmonary inflammation and the development of spontaneous lung tumors are important age-related lesions in mice. Therefore, gross and histological examination of the respiratory system is a critical component of geropathology research studies for translating surrogate endpoints to clinical aging studies. Collection, trimming, and processing of lung tissue from aged mice require a high-quality sequential process since aged mice are irreplaceable resource-intensive animal models. This protocol provides a basic technique that provides excellent sections for histological evaluation of the respiratory system of old mice suitable for most research applications...
2017: Pathobiology of Aging & Age related Diseases
https://www.readbyqxmd.com/read/28509580/use-of-minimal-residual-disease-assessment-in-the-treatment-of-chronic-lymphocytic-leukemia
#20
Carolyn Owen, Anna Christofides, Nathalie Johnson, Tatiana Lawrence, David MacDonald, Carol Ward
Progress in chronic lymphocytic leukemia (CLL) therapies has extended greatly the length and depth of remission, with the goal of treatment advancing towards a cure for some patients. Accordingly, clinical endpoints must evolve to capture these outcomes, and to provide faster access to novel therapies. Minimal residual disease (MRD) is an important endpoint representing more accurately the depth of remission than complete response (CR), and is highly prognostic of progression-free survival (PFS) and overall survival (OS)...
May 16, 2017: Leukemia & Lymphoma
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