A Primer on Using Biomarkers in Clinical Research

A Primer on Using Biomarkers in Clinical Research 

Biomarkers are biological molecules or genes that can be used to measure the effects of treatments. Biomarkers are used in clinical research to measure changes in protein, gene expression, or other biochemical pathways associated with a specific condition or response.  They provide a measurable, quantifiable outcome that can be used to gauge therapeutic efficacy and safety, and have revolutionized clinical research by enabling researchers to explore new treatment options more thoroughly.

Unlike visual assessments, biomarkers are often more sensitive and accurate in detecting efficacy, thus providing a more comprehensive picture of the effects of treatments. Compared to other techniques such as skin biopsies and blood tests, non-invasive biomarker analyses help detect minute changes in the treatment area, enabling researchers to be more precise. Though there are limitations with other more invasive sampling methods, such as negative impact on recruitment, pain, or possible scarring for participants, careful selection of investigators familiar with this type of evaluation can help minimize any disruption to the study.   


Benefiting from Biomarkers in Clinical Research 

Using biomarkers in clinical research offers several advantages, especially when compared to traditional visual assessments. The four main reasons for using biomarkers are as follows: 


  1. Gain Insight into Drug Mechanism of Action: Biomarker studies provide an effective way of understanding how drugs work, particularly when non-invasive biomarkers are used. This is because they can provide a more comprehensive assessment than traditional methods which are often limited by time constraints.


  1. Highly Sensitive Measure of Efficacy: Biomarkers have been proven to be more sensitive than other methods for measuring efficacy, such as clinical investigator assessments (visual), in most dermatology indications, making them ideal for use in clinical trials. 


  1. Personalized Medicine: Biomarkers can be very effective in certain drug indications, providing insight into the efficacy of a drug for individual patients. This is especially true in more advanced indications where traditional methods may not provide as much information.


  1. Increase Understanding of the Disease: Biomarkers can provide valuable information about the underlying cause of a disease and can be used to identify targets for further research. This could lead to the development of new treatments or drugs that may better address the needs of patients.


Different Biomarker Approaches 

Biomarkers have been used in clinical research for decades, as they offer a unique advantage over traditional visual assessment methods. Biomarker analyses provide a more sensitive approach to detecting efficacy outcomes, allowing researchers to identify subtle changes in cells and biochemical pathways that may be difficult to detect via visual assessment. 

Skin biopsies, blood tests, and tape stripping are three of the most commonly used biomarker assessment approaches. Skin biopsies allow researchers to collect samples from living tissue, providing them with a direct source of data regarding changes in cell structure and activity. Blood tests, on the other hand, provide a more indirect form of assessment via measurement of circulating markers such as hormones or metabolic byproducts. Tape stripping involves taking a sample from the top layer of skin using adhesive tape. This can provide insight into external factors such as air pollutants or allergens that may affect skin health. All three approaches have their own advantages and disadvantages depending on the type of research being conducted and the condition being studied. 

The sensitivity of biomarker analysis has made it a popular choice among researchers conducting clinical trials, especially for diseases that may be difficult to detect through visual assessment. This higher level of accuracy allows researchers to identify efficacy outcomes, providing them with an invaluable tool when assessing potential treatments. 

Compared to other techniques such as imaging, biomarker analysis offers a unique advantage in terms of its ability to provide data from living tissue samples. This allows researchers to accurately measure changes that may occur over time, providing them with a valuable tool for monitoring therapeutic efficacy. 

Despite these advantages, there are also limitations associated with traditional biomarker studies. For example, skin biopsy studies are often limited by the small amount of tissue available for analysis, while the accuracy of blood tests is dependent on accurate and timely sample collection, making it more difficult to use in certain contexts. Making sure to address these limitations is key for researchers running clinical trials. 


Use in Clinical Trials 

The way biomarker analyses evaluate efficacy in clinical trials are by providing an objective, quantitative measure of the drug’s effects on the body. Through advanced technology and data analysis, biomarkers can provide insights into a patient's response that were not previously available through traditional methods such as visual assessment or self-reporting. The use of biomarkers in clinical trials present many advantages compared to traditional methods such as: 


  • Cost savings due to shorter study durations;
  • Improved safety by accurately measuring side effects;
  • Superior accuracy and precision in measuring the effects of a drug;
  • High sensitivity, allowing researchers to detect changes over short time frames.


However, challenges and limitations should be considered when using biomarkers in clinical research. These include: 


  • The complexity of data analysis;
  • Difficulty in identifying suitable biomarkers;
  • Challenges in evaluating complex biological interactions;
  • Cost and availability of equipment, reagents, and other materials.


Biomarkers offer a unique opportunity to assess the efficacy of treatments in clinical trials with greater accuracy and sensitivity than traditional visual assessments. The implications of biomarkers on future trials are promising, and further research on their use should be conducted to understand how they can be leveraged optimally. Ultimately, biomarkers have the potential to revolutionize clinical trial design and enhance patient outcomes in the years ahead with the help of further scientific progress.  For further guidance on the use of biomarkers, Innovaderm Research can help you develop clinical trials to test innovative skin treatments, contact us here to learn more.

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