Abstract:
:The current cost of developing a successful drug is typically over a billion dollars, with the registration trial(s) determining the success or failure of the entire development program. Often the primary endpoint of these trials is a subjective assessment. For registration trials with subjective endpoints, a regulatory agency may require a blinded independent central review (BICR) of the trial data. The BICR is a mechanism to reduce bias in open-labeled trials and to potentially increase accuracy and precision. A decision tree algorithm has been developed that can be used to determine when and what type of a BICR is needed. The US FDA draft Guidance Standard for Clinical Trial Imaging Endpoints can be used as an effective process map in exploring the value and use of BICRs in imaging, and in any hard to interpret variable subjective assessment in general.
journal_name
Biomark Medjournal_title
Biomarkers in medicineauthors
Walovitch RC,Chokron P,Agarwal Sdoi
10.2217/bmm.12.74subject
Has Abstractpub_date
2012-12-01 00:00:00pages
839-47issue
6eissn
1752-0363issn
1752-0371journal_volume
6pub_type
杂志文章,评审abstract::The field of aortopathy, in common with other genomic disorders, is undergoing a revolution. This is largely driven by the implementation of newer forms of genetic sequencing (massively parallel or next-generation sequencing). Advantages conferred by this technology include reduced costs, reduced sequencing time and t...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm.13.74
更新日期:2013-08-01 00:00:00
abstract::The natriuretic peptide system comprises three structurally related peptides: atrial natriuretic peptide, B-type natriuretic peptide and C-type natriuretic peptide. In circulation, they play an important endocrine role in the regulation of cardiovascular homeostasis by maintaining blood pressure and extracellular flui...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm.10.67
更新日期:2010-08-01 00:00:00
abstract:AIM:LncRNAs may act as promising biomarkers in esophageal cancer (EC). Here, we illustrate the LncRNA profile and their clinical relevance in EC. PATIENTS & METHODS:In this study, we utilized the Cancer Genome Atlas RNA-sequencing and clinical data from 186 patients and 13 normal samples. Various statistical and gene ...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2018-0032
更新日期:2018-10-01 00:00:00
abstract:AIM:The aim of the present study is to evaluate the relationship between coronary collateral circulation (CCC) grade and serum IGF-1 levels in patients diagnosed with stable coronary artery disease. METHODS:Totally, 190 consecutive patients with stable coronary artery disease who underwent coronary angiography were in...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2016-0354
更新日期:2017-07-01 00:00:00
abstract::Tuberculosis (TB) and diabetes mellitus Type 2 (DM2) are two diseases as ancient as they are harmful to human health. The outcome for both diseases in part depends on immune and metabolic individual responses. DM2 is increasing yearly, mainly due to environmental, genetic and lifestyle habits. There are multiple evide...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm-2018-0050
更新日期:2018-09-01 00:00:00
abstract::In recent years, immune checkpoint inhibitors have rapidly changed treatment paradigms and have been pivotal for the treatment of advanced NSCLC patients. However, many patients don't respond to immunotherapy, and toxicities are a concern. Mounting evidence suggests that PD-L1 expression and tumor mutational burden ar...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2020-0310
更新日期:2020-10-01 00:00:00
abstract:AIM:To investigate the role of gelsolin-like actin-capping protein (CapG) in prostate cancer (PCa). MATERIALS & METHODS:CapG expression and its correlation with clinicopathological characters and patient prognosis were analyzed in 76 cases of PCa by immunohistochemistry and qRT-PCR. Then, the influence of CapG downreg...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2016-0186
更新日期:2016-12-01 00:00:00
abstract::Aim: Noninvasive assessments of C-reactive protein (CRP) in stress contexts have seldom been compared. This study evaluated CRP response to acute social stress as measured in saliva and dried blood spot (DBS). Materials & methods: African-Americans (N = 118; mean age = 32 years) participated in a laboratory-based soci...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2019-0391
更新日期:2020-04-01 00:00:00
abstract::Dr Jake Micallef speaks to Hannah L Wilson, Commissioning Editor: Dr Micallef has 20 years of experience in research and development and in the management of early-stage biotechnical companies, including the manufacture of biotechnology products and the establishment of manufacturing operations. Dr Micallef gained thi...
journal_title:Biomarkers in medicine
pub_type: 传,历史文章,面试
doi:10.2217/bmm.14.47
更新日期:2014-01-01 00:00:00
abstract:AIM:To evaluate the relationship between mean platelet volume (MPV) and red cell distribution width (RDW), and disease activity in rheumatoid arthritis (RA). PATIENTS & METHODS:Hundred RA and 100 controls were included. RESULTS:MPV and RDW were higher in RA (p < 0.0001). The cut-off levels of RDW and MPV were 14.8 an...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2016-0148
更新日期:2016-09-01 00:00:00
abstract:AIM:To establish a database for the associations between idiosyncratic drug reactions (IDRs) and human leukocyte antigens (HLAs) and to systematically assess the characteristics of the drug-HLA associations. MATERIALS & METHODS:Electronic databases were searched to extensively identify drug-HLA association studies fro...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm.15.98
更新日期:2015-01-01 00:00:00
abstract::With the regulatory approvals in Europe and the USA of trastuzumab-based anti-HER2 targeted therapy for upper gastrointestinal cancers in 2010, HER2 testing has now become universal for newly diagnosed cases of both breast cancer and adenocarcinomas of esophagus, stomach and gastroesophageal origin. In the 12 years or...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm.11.31
更新日期:2011-06-01 00:00:00
abstract:AIM:To determine the performance of plasma calprotectin as a marker of sepsis on intensive care unit (ICU) admission and as a marker of mortality day 30 post-ICU admission. MATERIALS & METHODS:Consecutive ICU patients were allocated to: sepsis (n = 15), postoperative inflammation (n = 23) and intoxication without infl...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2016-0032
更新日期:2016-08-01 00:00:00
abstract:AIM:Investigate the correlation between paraoxonase 2 (PON2) Ser311Cys polymorphism as well as the peroxisome proliferator-activated receptor gamma (PPARG) His477His polymorphism and the susceptibility to development of coronary heart diseases (CHD) through a meta-analysis. METHODS:Odds ratio and the corresponding 95%...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm-2017-0227
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:Autism spectrum disorder (ASD) represents a wide range of neurodevelopmental disorders characterized by impairments in social interaction, language, communication and range of interests. Autism is usually diagnosed in children 3-5 years of age using behavioral characteristics; thus, diagnosis shortly after b...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm.12.108
更新日期:2013-04-01 00:00:00
abstract:AIM:To assess the possible relationship between coronary atherosclerosis markers, pericardial fat volume (PFV) and coronary artery calcification, with ECG markers of index of the cardiac electrophysiological balance (iCEB) and transmural dispersion of the repolarization in patients with suspected coronary artery diseas...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2017-0187
更新日期:2018-04-01 00:00:00
abstract::Impression cytology (IC) is a technique which permits the retrieval of the outermost layer of ocular surface cells via the use of various types of filters. It is a minimally invasive method of evaluating human conjunctival epithelial cell morphology in the diagnosis of dry eye disease, a common and distressing disorde...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm-2017-0124
更新日期:2017-12-01 00:00:00
abstract:AIMS:Progressive vasodegeneration in microvascular beds is the major underlying factor in initiation and progression of diabetic complications. Chemerin shows a strong correlation with various facets of the metabolic syndrome, which is associated with dysregulated angiogenesis. VEGF is shown to have an angiogenic role ...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm.11.85
更新日期:2012-02-01 00:00:00
abstract::Currently, decision-making for breast cancer treatment in the clinical setting is mainly based on clinical data, histomorphological features of the tumor tissue and a few cancer biomarkers such as steroid hormone receptor status (estrogen and progesterone receptors) and oncoprotein HER2 status. Although various therap...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm.10.73
更新日期:2010-08-01 00:00:00
abstract:AIM:Ankylosing spondylitis (AS) is a chronic systemic inflammatory rheumatic disorder that primarily affects the axial skeleton. To date there is no satisfactory biomarker for diagnosis or prognosis of AS. This study is focused on detection of potential biomarkers for the diagnosis of AS using surface-enhanced laser de...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/17520363.2.1.23
更新日期:2008-02-01 00:00:00
abstract:AIM:The aim was to investigate the inflammatory biomarker YKL-40 as a monitor of myocardial ischemia in patients with coronary artery disease (CAD). METHODS:A total of 311 patients with stable CAD were included. Blood samples were taken at baseline, the day after coronary angiography and/or after percutaneous coronary...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm.14.20
更新日期:2014-01-01 00:00:00
abstract:AIM:The role of octamer-binding transcription factor 4 (Oct4) in gastric cancer (GC) progression is still under debate and reported results are inconsistent. Therefore, we conducted a meta-analysis to evaluate the clinicopathological and prognostic significance of Oct4 expression in patients with GC. MATERIALS & METHO...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,meta分析
doi:10.2217/bmm-2018-0086
更新日期:2019-02-01 00:00:00
abstract::Letter in regards to: Akboga MK, Balci KG, Maden O et al. Usefulness of monocyte to HDL-cholesterol ratio to predict high SYNTAX score in patients with stable coronary artery disease. Biomark. Med. 10(4), 375-383 (2016). ...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2016-0326
更新日期:2017-08-01 00:00:00
abstract::Tuberculosis is a public health concern worldwide. Particularly worrying is the emergence of severe forms of drug resistance, such as extensively drug resistant and totally drug resistant tuberculosis, with few treatment options for the afflicted patients. To avoid further spread of drug resistance, its early detectio...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm.14.73
更新日期:2014-01-01 00:00:00
abstract::Aim: The diagnostic and prognostic role of procalcitonin (PCT) and mid-regional-pro-adrenomedullin (MR-proADM) were investigated in patients with pneumonia. Material & methods: A total of 168 and 77 patients with pneumonia enrolled in two different hospital settings, an internal medicine unit and an emergency unit wer...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2019-0414
更新日期:2020-05-01 00:00:00
abstract:AIM:We evaluated the effect of lncRNA SOX2OT expression and its SNP in tumorigenesis and development of breast cancer (BC) in a case-control study. METHODS:A total of 1106 individuals, 505 newly diagnosed BC patients and 601 age-matched controls (±2 years) were testified. Real-time PCR was adopted for testing tissues'...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2016-0238
更新日期:2017-03-01 00:00:00
abstract::Background: This study aimed to identify glioblastoma prognosis-associated genes with potential diagnosis or prognosis values using integrated bioinformatics analysis. Results: In total, 1831 differentially expressed genes (DEGs) between the glioblastoma and control samples were identified and were clustered into seve...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2020-0341
更新日期:2020-11-01 00:00:00
abstract::Cardiovascular disease refers to different diseases involving the heart and/or the arteries and/or the veins. Cardiovascular disease, overall considered, is a notable source of morbidity and mortality worldwide. Therefore, several research studies are dedicated to explore, by means of biomarkers, the possiblity to cal...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm-2018-0056
更新日期:2018-09-01 00:00:00
abstract::The current review article aims to provide an up-to-date summary of previous studies in humans that have reported the association between circulating endostatin levels and different cardiovascular phenotypes. We also aim to provide suggestions for future directions of future research evaluating endostatin as a clinica...
journal_title:Biomarkers in medicine
pub_type: 杂志文章,评审
doi:10.2217/bmm-2017-0025
更新日期:2017-10-01 00:00:00
abstract::Aim: To investigate the role of endothelial PV-1 in patients with untreated celiac disease (CD)-associated liver injury. Materials & methods: PV-1 and PV-1 mRNA were measured in intestinal biopsies from untreated CD patients with elevated or normal alanine transaminase levels, controls, patients with inflammatory bowe...
journal_title:Biomarkers in medicine
pub_type: 杂志文章
doi:10.2217/bmm-2020-0281
更新日期:2020-12-01 00:00:00