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Bioanalysis Apr 2017With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized... (Review)
Review
With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized process' for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies to evaluate analyte stability. By leveraging representative industry experience, we have attempted to provide an overview of critical aspects of biomarker specimen stability commonly encountered during clinical development, including: planning of clinical sample collection procedures, clinical site training, selection of sample preservation buffers, shipping logistics, fit-for-purpose stability assessments in the analytical laboratory and presentation of case studies covering widely utilized biomarker specimen types.
Topics: Biomarkers; Humans; Preservation, Biological; Protein Stability; Proteins; Specimen Handling; Transportation
PubMed: 28508714
DOI: 10.4155/bio-2017-0009 -
Eye & Contact Lens Mar 2020Allergic conjunctival diseases (ACDs) are a group of ocular allergies that include allergic conjunctivitis, atopic keratoconjunctivitis, vernal keratoconjunctivitis, and... (Review)
Review
Allergic conjunctival diseases (ACDs) are a group of ocular allergies that include allergic conjunctivitis, atopic keratoconjunctivitis, vernal keratoconjunctivitis, and giant papillary conjunctivitis. Although a large body of information exists on the pathophysiology of ACDs, this has not yet lead to the development of clear recommendations and guidelines for the diagnosis of ACDs or development of conclusive and objective diagnostic tools. Identification of objectively measurable biomarkers that represent the molecular and cellular mechanisms associated with ACDs will be an important step toward achieving these aims. This is a comprehensive review of biological markers that have the potential to become "biomarker(s)" for ACDs and aid in the classification, diagnosis, and development of new therapeutic strategies for these group of allergic conditions.
Topics: Biomarkers; Conjunctiva; Conjunctivitis, Allergic; Eye Proteins; Humans
PubMed: 32097185
DOI: 10.1097/ICL.0000000000000688 -
BMC Medicine May 2023Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a multifaceted condition that affects most body systems. There is currently no known diagnostic biomarker;...
BACKGROUND
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a multifaceted condition that affects most body systems. There is currently no known diagnostic biomarker; instead, diagnosis is dependent on application of symptom-based case criteria following exclusion of any other potential medical conditions. While there are some studies that report potential biomarkers for ME/CFS, their efficacy has not been validated. The aim of this systematic review is to collate and appraise literature pertaining to a potential biomarker(s) which may effectively differentiate ME/CFS patients from healthy controls.
METHODS
This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane review guidelines. PubMed, Embase and Scopus were systematically searched for articles containing "biomarker" and "ME/CFS" keywords in the abstract or title and if they included the following criteria: (1) were observational studies published between December 1994 and April 2022; (2) involved adult human participants; (3) full text is available in English (4) original research; (5) diagnosis of ME/CFS patients made according to the Fukuda criteria (1994), Canadian Consensus Criteria (2003), International Consensus Criteria (2011) or Institute of Medicine Criteria (2015); (6) study investigated potential biomarkers of ME/CFS compared to healthy controls. Quality and Bias were assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Case Control Studies.
RESULTS
A total of 101 publications were included in this systematic review. Potential biomarkers ranged from genetic/epigenetic (19.8%), immunological (29.7%), metabolomics/mitochondrial/microbiome (14.85%), endovascular/circulatory (17.82%), neurological (7.92%), ion channel (8.91%) and physical dysfunction biomarkers (8.91%). Most of the potential biomarkers reported were blood-based (79.2%). Use of lymphocytes as a model to investigate ME/CFS pathology was prominent among immune-based biomarkers. Most biomarkers had secondary (43.56%) or tertiary (54.47%) selectivity, which is the ability for the biomarker to identify a disease-causing agent, and a moderate (59.40%) to complex (39.60%) ease-of-detection, including the requirement of specialised equipment.
CONCLUSIONS
All potential ME/CFS biomarkers differed in efficiency, quality, and translatability as a diagnostic marker. Reproducibility of findings between the included publications were limited, however, several studies validated the involvement of immune dysfunction in the pathology of ME/CFS and the use of lymphocytes as a model to investigate the pathomechanism of illness. The heterogeneity shown across many of the included studies highlights the need for multidisciplinary research and uniform protocols in ME/CFS biomarker research.
Topics: United States; Adult; Humans; Canada; Fatigue Syndrome, Chronic; Reproducibility of Results; Academies and Institutes; Biomarkers
PubMed: 37226227
DOI: 10.1186/s12916-023-02893-9 -
Bioanalysis Jun 2018
Topics: Biomarkers; Chemistry Techniques, Analytical; Humans; Reproducibility of Results
PubMed: 29939799
DOI: 10.4155/bio-2018-0127 -
Gene Jan 2022This paper reviews theory of DNB (Dynamical Network Biomarkers) and its applications including both modern medicine and traditional medicine. We show that omics data... (Review)
Review
This paper reviews theory of DNB (Dynamical Network Biomarkers) and its applications including both modern medicine and traditional medicine. We show that omics data such as gene/protein expression profiles can be effectively used to detect pre-disease states before critical transitions from healthy states to disease states by using the DNB theory. The DNB theory with big biological data is expected to lead to ultra-early precision and preventive medicine.
Topics: Algorithms; Biomarkers; Disease; Disease Progression; Gene Expression Profiling; Gene Regulatory Networks; Genomics; Humans; Proteomics; Time Factors
PubMed: 34626720
DOI: 10.1016/j.gene.2021.145997 -
European Journal of Cancer (Oxford,... Sep 2022Phase 1 immuno-oncology (IO) trials frequently involve pharmacodynamic (PD) biomarker assessments involving tumour biopsies and/or blood collection, with increasing use... (Review)
Review
BACKGROUND
Phase 1 immuno-oncology (IO) trials frequently involve pharmacodynamic (PD) biomarker assessments involving tumour biopsies and/or blood collection, with increasing use of molecular imaging. PD biomarkers are set to play a fundamental role in early drug development of immuno-oncology (IO) agents. In the IO era, the impact of PD biomarkers for confirmation of biologic activity and their role in subsequent drug development have not been investigated.
METHODS
Phase 1 studies published between January 2014 and December 2020 were reviewed. Studies that reported on-treatment PD biomarkers [tissue-derived (tissue-PD), blood-based (blood-PD) and imaging-based (imaging-PD)] were analysed. PD biomarker results and their correlation with clinical activity endpoints were evaluated. Authors' statements on the influence of PD biomarkers on further drug development decisions, and subsequent citations of PD biomarker study results were recorded.
RESULTS
Among 386 trials, the most frequent IO agent classes evaluated were vaccines (32%) and PD-(L)1 inhibitors (25%). No PD biomarker assessments were reported in 100 trials (26%). Of the remaining 286, blood-PD, tissue-PD, and imaging-PD data were reported in 270 (94%), 94 (33%), and 12 (4%) trials, respectively. Assessments of more than one PD biomarker type were reported in 82 studies (29%). Similar proportions of blood-PD (9%), tissue-PD (7%), and imaging-PD studies (8%) had positive results that correlated with clinical activity. Results of 22 PD biomarker studies (8%) were referenced in subsequent clinical trials.
CONCLUSIONS
Most phase 1 IO studies performed PD biomarker assessments. Overall, positive PD biomarker results were infrequently correlated with clinical activity or cited in subsequent trials, suggesting a limited impact on subsequent drug development. With emerging health regulatory emphasis on optimal dose selection based on PD activity, more informative and integrative multiplexed assays that capture the complexity of tumour-host immunity interactions are warranted to improve phase 1 IO trial methodology.
Topics: Biomarkers; Biomarkers, Tumor; Biopsy; Clinical Trials, Phase I as Topic; Humans; Medical Oncology; Molecular Imaging; Neoplasms
PubMed: 35872510
DOI: 10.1016/j.ejca.2022.06.045 -
Rheumatology (Oxford, England) Jan 2020Adding biomarker information to real world datasets (e.g. biomarker data collected into disease/drug registries) can enhance mechanistic understanding of intra-patient... (Review)
Review
Adding biomarker information to real world datasets (e.g. biomarker data collected into disease/drug registries) can enhance mechanistic understanding of intra-patient differences in disease trajectories and differences in important clinical outcomes. Biomarkers can detect pathologies present early in disease potentially paving the way for preventative intervention strategies, which may help patients to avoid disability, poor treatment outcome, disease sequelae and premature mortality. However, adding biomarker data to real world datasets comes with a number of important challenges including sample collection and storage, study design and data analysis and interpretation. In this narrative review we will consider the benefits and challenges of adding biomarker data to real world datasets and discuss how biomarker data have added to our understanding of complex diseases, focusing on rheumatoid arthritis.
Topics: Biomarkers; Data Interpretation, Statistical; Humans; Pragmatic Clinical Trials as Topic; Registries; Research Design; Rheumatology
PubMed: 31329972
DOI: 10.1093/rheumatology/kez113 -
Genes May 2021Asthma is the most common respiratory disease. It has multiple phenotypes thatcan be partially differentiated by measuring the disease's specific... (Review)
Review
Asthma is the most common respiratory disease. It has multiple phenotypes thatcan be partially differentiated by measuring the disease's specific characteristics-biomarkers. The pathogenetic mechanisms are complex, and it is still a challenge to choose suitable biomarkers to adequately stratify patients, which became especially important with the introduction of biologicals in asthma treatment. Usage of biomarkers and an understanding of the underlying pathobiological mechanisms lead to the definition of endotypes. Asthma can be broadly divided into two endotypes, T2-high and T2-low. The right combination of various biomarkers in different phenotypes is under investigation, hoping to help researchers and clinicians in better disease evaluation since theindividual approach and personalized medicine are imperative. Multiple biomarkers are superior to a single biomarker.
Topics: Asthma; Biomarkers; Humans; Phenotype; Sputum
PubMed: 34070316
DOI: 10.3390/genes12060801 -
BioMed Research International 2015Endometriosis is histologically characterized by the displacement of endometrial tissue to extrauterine locations including the pelvic peritoneum, ovaries, and bowel. An... (Review)
Review
Endometriosis is histologically characterized by the displacement of endometrial tissue to extrauterine locations including the pelvic peritoneum, ovaries, and bowel. An important cause of infertility and pelvic pain, the individual and global socioeconomic burden of endometriosis is significant. Laparoscopy remains the gold standard for the diagnosis of the condition. However, the invasive nature of surgery, coupled with the lack of a laboratory biomarker for the disease, results in a mean latency of 7-11 years from onset of symptoms to definitive diagnosis. Unfortunately, the delay in diagnosis may have significant consequences in terms of disease progression. The discovery of a sufficiently sensitive and specific biomarker for the nonsurgical detection of endometriosis promises earlier diagnosis and prevention of deleterious sequelae and represents a clear research priority. In this review, we describe and discuss the current status of biomarkers of endometriosis in plasma, urine, and endometrium.
Topics: Biomarkers; Early Diagnosis; Endometriosis; Endometrium; Female; Humans; Reproducibility of Results; Sensitivity and Specificity
PubMed: 26240814
DOI: 10.1155/2015/130854 -
Trends in Molecular Medicine Jan 2018Glaucoma is one of the leading causes of blindness globally, and is characterized by loss of retinal ganglion cells (RGCs). Because vision loss in glaucoma is not... (Review)
Review
Glaucoma is one of the leading causes of blindness globally, and is characterized by loss of retinal ganglion cells (RGCs). Because vision loss in glaucoma is not reversible, therapeutic interventions early in disease are highly desirable. However, owing to the current limitations in evaluating glaucomatous neurodegeneration, it is challenging to monitor the disease severity and progression objectively, and to design rational therapeutic strategies accordingly. Therefore, there is a clear need to identify quantifiable molecular biomarkers of glaucomatous neurodegeneration. As such, in our opinion, molecular biomarker(s) that specifically reflect stress or death of RGCs, and which correlate with disease severity, progression, and response to therapy, are highly desirable.
Topics: Animals; Biomarkers; Cell Death; Disease Models, Animal; Disease Progression; Glaucoma; Humans; Prognosis; Retinal Ganglion Cells
PubMed: 29233479
DOI: 10.1016/j.molmed.2017.11.004