The Role of Biomarkers in Personalized Oncology Clinical Development

Biomarkers have played a prominent role in oncology clinical development for the past 15 to 20 years. Biomarkers are used in different stages of clinical development process, such as drug development, stratification, patient selection, and performance assessment. The importance of biomarkers in clinical trials is undeniable because clinical trials are selected based on the biomarkers. The traditional cancer treatment considers the origin of the tumor, histology, molecular technology, and new drug development based on the tumor-specific biomarkers. Biomarkers have introduced a new era in personalized oncology clinical development.

What are biomarkers?

Biomarkers are the biological indicators that indicate any normal or abnormal process exists within body fluids or tissues. Biomarkers act as a crucial indicator for identifying how well the body is responding against a specific treatment and play an important determining factor in oncology clinical development.

How Biomarkers Are Shaping Oncology Clinical Development

The advanced drug development for cancer therapies targets specific mutation indicators or biomarkers for clinical trial design. Master protocols like basket trials, platform trials, or umbrella trials consider evaluating histology-oriented oncology therapies having a common biomarker specification for multiple tumor types. Besides this, rapid oncology clinical development has become simpler by assessing the different biomarkers for multiple tumor categories rather than considering only a single cause. 

Biomarkers in oncology clinical development act as an indicator showcasing the rationale behind the application of certain therapies by selecting a specific cancer type, and they identify what changes of state or processes a therapy is making within the body after the application. 

Biomarkers in trial design

Master protocols such as umbrella, basket, or platform trials design clinical trials based on several different layers. 

• Patients having specific biomarker profiling are considered in clinical trial design.
• An all-comers patient design in clinical trials by stratification based on biomarker status is a well-known approach adopted by many researchers for oncology clinical development. 
• Specifying the subgroup considering the patients with specific histology or biomarker profiling from the larger section of patients is adopted in clinical trial design.

Types of Biomarkers and Impact on Oncology Clinical Development

• Genetic biomarkers give glimpses of genetic makeup. It identifies the genetic variation and mutation that help in personalized medicine and therapy development. 
• Protein biomarkers give the clues on various changes of physiological processes within the body. Antibodies, enzymes, or hormones are the common examples of protein biomarkers that are crucial for the diagnosis of any disease. 
• Metabolic biomarkers give the snapshot of chemical processes running within the body. It gives crucial information on diabetes or any metabolic disorders. Metabolic biomarkers are present in blood or urine and provide deep insight for assessment. 
• Imaging biomarkers are useful indicators for identifying tumors on specific organs that provide the visualization of the entire biological process. 
• Providing the glimpses of cellular health, like cell structure and functions, gives the indications of diseases that help in oncology clinical development.

Biomarkers act as crucial indicators of assessment in the modern oncology clinical development process. It is a groundbreaking discovery that helps in clinical trial design, supports predicting budget and estimating the timeline, proper resource allocation, and taking necessary changes essential for clinical development.