Clinical Insight

Clinical Insight, a series of technical reports brought to you by ACM Global Laboratories, is written by our team of experts on issues affecting clinical testing today. Based on their knowledge and experience with safety and specialty testing, our experts provide detailed information concerning current methodology, specimen requirements, and reference ranges on new and specialized tests.

In Clinical Insight, our experts take it one step further to provide their opinions on the clinical significance of specific tests and how they can impact your clinical trial.

How Digital Pathology is Revolutionizing Clinical Trials
The emergence of digital pathology presents an opportunity for central laboratories to support highly targeted therapeutics and precision medicine even further, offering many advantages to both diagnostic and clinical trials testing. This issue explains the noteworthy progress in the industry’s wider acceptance of digital pathology systems and its many benefits.

Allergen Testing in Clinical Trials
Developing treatments for allergy is dependent on technology that identifies IgE and allergen-specific IgE. With the rapid improvement in this technology, trial sponsors should understand the many options available.

Broadening Pathology Beyond Disease Diagnosis and Classification
Demand for anatomic pathology services within clinical trials is on the rise, driven by shifting approaches in translational medicine and clinical development, together with a heightened need for more consistent and less variable tissue analysis and interpretation.  

The Role of the Central Microbiology Lab in Streamlining Clinical Development
Many antibiotics discovered in the 1970s and 1980s are still used today for many infections. The availability of antibiotics and their overwhelming effectiveness for several common infections have provided a false sense of security that we have conquered many infectious diseases. 

Setting the Standard for Central Labs in Asia Pacific and China
Central laboratories have become an important part of running global and large multi-regional clinical trials in Europe and the United States. With the rapid increase in the number of global clinical trials in China and the Asia Pacific region, trial sponsors should understand how to choose central labs in those regions, and the reasons for those choices.

Increasing Standardization and Stability of Multicolor Flow Cytometry Using Duraclone Dry Reagent Technology
Flow cytometry is a powerful tool in identifying and enumerating distinct cell populations for numerous therapeutic areas. Multicolor flow cytometry can dramatically increase the ability to detect multiple phenotypically distinct cellular populations in a single interrogation. 

Playing a Central Role in Treating Metabolic Syndrome
In this Clinical Insight, we provide an overview on the history and evolution of metabolic syndrome, and discuss the ongoing debate that still exists around the criteria for diagnosing it. We also highlight some of the common tests, methodologies and instrumentation being used by central laboratories today to enable metabolic syndrome to be quickly and easily detected.

Endpoint Based Protocol Development: A Central Laboratory Perspective
Understanding the specific laboratory testing requirements early in the protocol development phase is a process that ideally involves the scientific expertise of the chosen testing laboratory. The goal of this approach is to ensure that appropriate testing is accounted for early in the protocol development.

The Evolving Relationship between HbA1c and eAG for Clinical Trials Testing
The glycated haemoglobin, also called HbA1c, test has been used as a monitoring control for diabetic patients for more than 30 years, which provides a picture of the patient's overall glucose control. This issue helps explain the purified reference calibrators and new reference method for HbA1c developed by the IFCC.

Biomarkers of Toxicity Panel in Clinical Trials
Most drug candidates are discontinued because of induced organ toxicity and half of them owe this to liver toxicity. This issue explains why drug developers need to be aware of the latest options for liver and kidney laboratory safety testing, and understand the importance of testing a combination of novel, early predictive toxicity biomarkers, along with the conventional tests.

Measurement of Cancer Biomarkers by Flow Cytometry and Molecular Technology
This issue will discuss what are biomarkers and the role they play in clinical oncology, how flow cytometry can be used to identify cancer biomarkers and how molecular diagnostic techniques are used to assist the diagnosis and monitoring of many genetic, infectious and malignant forms of haematological disease and other types of cancer.

HLA-B27 Screening by Flow Cytometry
As little is known about HLA-B27, this issue aims to provide a brief background, and the significance of this testing, along with why the relationship between different diseases and HLA-B27 is yet to be fully understood.

The Evolving Role of LIMS Database in Global Clinical Trial Testing
This issue focuses on LIMS (Laboratory Information Management Systems); what is it, how it has developed within the clinical trials industry and where the future possibilities lie in improving its functionality and integration with other processes.

An Insight into the Role of an ACM Project Manager
Understand the relationship between the client and the Project manager, which allows improved communication and consistency across trials moving forward.

Flow Cytometric Multiplexing: Multiple Analyte Detection System
The latest flow cytometer technology can detect and simultaneously measure up to 20 cytokines in a small sample volume. Using the same principles as ELISA, this report presents scenarios of the advantages of flow cytometric multiplexing.

The Use of Liquid-based Collection Methods for Women's Health Screening
This issue reports on the advantages of liquid-based collection methods for not only cervical cancer screening, but also for sexually transmitted diseases. Includes analysis on current HPV, Chlamydia and Neisseria Gonorrhoeae testing.

Flow Cytometrys Central Role in Diagnosis of PNH
Flow cytometry has replaced the Ham test as the gold standard technique for diagnosing patients with Paroxysmal Nocturnal Haemoglobinuria (PNH). This report highlights the significant contributions flow cytometry has made in defining phenotypes of PNH.

Understand Physiological Processes between Energy Metabolism and Appetite Regulation with Tests
With the worldwide rise of obesity and metabolic diseases, labs should conduct ongoing test monitoring to see what may be of value for obesity. This report covers which tests are well-established and which provide beneficial results.

Nephrotoxicity Testing in Clinical Trials to Improve Patient Safety
This issue presents newer procedures for the evaluation of kidney function such as the Modification of Diet in Renal Disease (MDRD)2 equation and Cystatin C in the assessment of kidney function in non transplant patients.

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