Historically, biomarkers have been used in treating and diagnosing diseases and medical conditions. Today numerous biomarker platforms are commercially available for clinical use. In clinical studies, scientists are relying increasingly on biomarkers to classify, manage and treat the study population. Hence, newer and more reliable biomarkers are needed for diagnosing, ministering, and monitoring drug effects in clinical trials. Besides, biomarkers are also crucial for the follow-on care of patients. However, there are several challenges sponsors face while validating a potential biomarker. Hence, the current article highlights the limitations biomarker validation services encounter while validating a biomarker in clinical studies.
Biomarker validation challenges in clinical trials
Earlier, the lack of robust clinical studies was the primary reason for underdeveloped biomarker investigations while selecting an ideal biomarker candidate. Several statistically underpowered clinical studies are conducted across a broad range of diseases. However, many studies not only employ genomic platforms but also include protein and metabolomic analyses. Most of these studies use patient peripheral blood as study samples. The principal benefit of utilizing these sample types is that they are readily available and require minimally invasive procedures. Besides, the biomarker lab must also focus on other readily available sample types, such as blood and urine, as they can help develop a robust biomarker system.
Clinical studies with statistically empowered data sets are crucial for biomarker validation. However, clinical, ethical, and regulatory concerns make conducting biomarker studies difficult and complex.. Besides, these studies generate a large amount of data that may require more sophisticated tools and strategies for evaluating and interpreting these datasets. There are several other issues when choosing an ideal biomarker during clinical studies. Some common challenges include
- Poor classification of candidate biomarkers
- Insufficient confirmation using secondary methods
- Employing a single interrogation pathway that may lead to biased conclusions
- Lack of comparable studies.
The lack of similar or comparable studies is a significant issue for skepticism among the scientific community. Several biomarker experts in this field have recognized the problem and have started focusing on integrative approaches with datasets across comparative studies. However, efforts are still needed to overcome other issues raised above.
Besides, underdeveloped platforms and technologies are other causes of insufficient transitional development of biomarkers across the drug discovery process. While biomarker assays are generally laboratory-based or point-of-care platforms, they do not incorporate all the features of a clinical biomarker. A considerable effort is required in assay development and validation to ensure the smooth transition of a biomarker candidate to clinical settings. Besides, the current patent environment is bombarded with numerous IPs and patents with little to no clear intentions about holistic applications of the biomarker candidate. However, this situation is slowly changing with rigorous rules and recommendations such as FDA’s biomarker validation guidelines. Although, such stringent regulations can be limiting for small investors.
Biomarkers have numerous applications in clinical and non-clinical environments. They serve as potential standards for disease-specific quality assurance and treatment. Besides the clinical trial surroundings, biomarkers can help identify high-risk environments, avoid invasive therapeutics and assist interventions in a clinical setting. However, clinical biomarker services must focus on robust biomarker validation for its sustained evolution in clinical studies.