Biomarkers present an enormous opportunity while introducing numerous complexities for clinical trials. From picking the right biomarker, whether it be a surrogate or true clinical endpoint, and navigating regulatory requirements, there are many challenges involved in utilizing biomarkers in clinical trials.

The importance of biomarkers in modern medicine cannot be understated. Implementing non-invasive, targeted, and personalized medicine has become the standard of care for diagnosing and treating many disease states. 

With biomarkers, we can transition our focus from the treatment of late-stage diseases such as metastatic cancer to preventing and catching diseases at an early stage.

Tissue biomarker services through clinical research organizations can be the answer to many clinical trial concerns. Experience in the industry, adequate laboratory resources, and a disease-state and clinical trial expertise all contribute to making a partnership beneficial for many trial hurdles, especially ones that are biomarker related.

What Are Tissue Biomarker Services?

Tissue biomarkers have become increasingly useful and popular in translating important disease and patient-specific treatment options in previous years. Researchers and clinicians can detect thousands of unique biomarkers. These include cellular signaling products, tissue morphology differences, and protein expression levels.

These microscopic indicators can be crucial to forming a definitive diagnosis, predicting the proper prognosis, or even predicting which treatment option will lead to the best patient outcome. 

Simply put, clinical research companies provide tissue biomarker services to describe biomarkers. However, knowing exactly the extent of what biomarker services can do and how to implement their capabilities into clinical research can feel like a tremendous undertaking. 

Immunohistochemistry, tissue microarrays, histological pathological techniques, and imaging analysis all give these research companies incredibly diverse ways to provide their services to clients. 

Having a strategy well in advance is more important than ever in conducting global clinical trials with increasing trial costs and demands. Below, we are going to discuss what biomarkers are, when to use them, and how they can make an impact in clinical research. 

Biospecimens

Biospecimens form the foundation for biomarker research. They are material from humans, animals, or plants, such as urine, blood, tissue, cells, DNA, RNA, or protein. In the setting of clinical research, we will be focusing on human-based biospecimens.

Most commonly, biospecimens are obtained from either a public or private biorepository. Depending on the type of biospecimens required, certain biorepositories can be accessed to draw whatever biomarker information is required to support the research. 

Many clinical research organizations already have their own biorepository of commonly researched specimens or have intricate connections to well-known biorepositories across the globe.

Additionally, certain research organizations have the ability to utilize biomarker testing service labs to streamline the search for a specific biomarker, leading to even less work and headaches for researchers. This technology can identify many genomic and immunological biomarkers quickly and easily.     

Some research organizations can even incorporate pathology services at the molecular level with biomarkers. Assay development and pathologist training have the potential to be instrumental in clinical trial support.

What Are Diagnostic Biomarkers? 

Diagnostic biomarkers are molecular signatures that can be used to diagnose and monitor a patient’s disease state. There are an overwhelming number of useful biomarkers and numerous more that do not yet have an identifiable clinical use.

Once we discover a biomarker and have a proposed use for it, there are many criteria to evaluate regarding its utility and validity. This is one of the main reasons to employ a tissue biomarker service, as they usually have a lot of these early considerations completed.

To begin, a biomarker test must have a degree of analytical validity. In other words, the test must be reproducible in either the same person or across persons with similar disease states. An example could be the prostate-specific antigen (PSA). PSA has no clinically meaningful value if we cannot compare it across other men with suspected prostate cancer. 

In addition, to make the test reproducible, it must also be accurate within a certain amount of confidence. Once again, biomarker service organizations have established laboratories that utilize CLIA-certified research laboratories to ensure quick, accurate testing results.

Along with analytical validity, clinical validity must similarly be evaluated. The biomarker must be medically meaningful, meaning it must serve a role in disease prevention, diagnosis, or treatment. 

It should also be able to distinguish a patient in comparison to the biomarker’s reference range and with other patients in the same disease state. Without medical integration, a biomarker may only be exploratory in nature.

How Are Biomarkers Useful?

Clinical validity translates into clinical utility – another consideration in biomarker test evaluations. Utility describes how useful a biomarker is. Now that validity has been established, meaning it is medically meaningful, we must ask ourselves if the test can be applied to improve health care. A prohibitively expensive, invasive, or inaccessible test will not have any clinical utility, even if it is valid. A clinically useful biomarker can change a patient’s health outcomes.

Outside of validity and utility decisions, biomarker testing services can help with cost-effectiveness obstacles. A well-connected testing service or clinical research organization (CRO) can access some of the largest networks of biorepositories or research sites globally across many diverse disease types, even with difficult protocol requirements. 

There can be psychological and ethical implications to implementing biomarker tests that can also make utilization difficult. Ultimately, there needs to be a therapeutic benefit or value-added when making the decision to use a biomarker test.

How (and When) to Utilize Biomarker Tissue Services

The decision to enlist the assistance of a biomarker tissue service is important and should be carefully considered. However, the payoff can be streamlined, well-organized, and effective support for a clinical trial that can make the difference between success and failure.

Recruiting support from the industry can help guide a clinical trial through regulatory pitfalls. The FDA provides industry guidance and support documents outlining the proper use of biorepositories and implementation of biomarker tests in clinical trials. 

Finding the right tissue service experienced with regulatory bodies such as the FDA can prevent a lot of headaches and stress when it comes to conducting a trial.

To design more efficient clinical trials, biomarker tissue services can sometimes recommend alterations to trial design using adaptations or even surrogate biomarkers. Surrogate biomarkers are biomarkers that substitute true clinical biomarkers but can be equally useful, depending on the disease state. 

An example of a surrogate biomarker could be thyroid stimulating hormone (TSH) as a surrogate for hypothyroidism. In some cases, utilizing a surrogate can save a clinical trial tremendously from a financial and time standpoint.   

Throughout a clinical trial, biomarker tissue service organizations can help clients distinguish biomarkers in the study patient population. Moreover, they can provide guidance at every stage of clinical development, such as assisting in creating new study cohorts.

Furthermore, partnering with a laboratory that is experienced with immunohistochemistry (IHC) biomarker analysis should be a primary consideration. This technology has become an integral part of targeted and precision medicine in clinical trials today. 

These biomarkers are very useful for the ever-expanding research areas of pathology and oncology, specifically, and have led to numerous drug discoveries in recent years. For example, the identification of tumor antigens and cancer-cell-specific antibodies through IHC can very accurately assess a patient’s disease progression. 

In addition, many of the pharmaceutical industry’s newest, most effective anti-cancer agents are immune-oncological in nature and will depend on the use of IHC to test safety and efficacy.

To further compound the importance of having reliable IHC and other biomarker assays readily available, many clinical trials and pharmaceutical companies will not only require these assays but also have tight deadlines requiring quick and convenient access to accurate and validated tests. 

Sometimes, utilizing the services of a tissue biomarker service can be the only solution to these problems.

Choosing iProcess Global Research

At iProcess, you can expect to work with a team of individuals that will not only be able to provide the highest quality specimens that will meet research deadlines, but you will find a well-connected network of over 1000 sites globally capable of a variety of tissue biomarker services cohesive with any research project. 

These sites offer an array of services that can be uniquely tailored to any specific research needs. If biomarker services will be useful for your clinical trial, iProcess has experience working with major pharmaceutical, diagnostic, and research organizations to help support any clinical trial endeavor. 

Accurate analysis of trial data depends on having access to the best quality biospecimens, and it is essential to have access to repositories with sufficient specimens. With iProcess, you can depend on the right laboratory partnerships to ensure clinical trial success, and obtaining a quote is free, quick, and easy.

Sources:

Making Meaningful Clinical Use of Biomarkers | PMC

Biomarker definitions and their applications | PMC 

Evaluating the Clinical Utility of a Biomarker | PMC