A biomarker is a quantifiable biological characteristic or molecule which is utilized by clinical research scientists to identify a disease. Validation, on the other hand, is the process used to verify the accuracy of a biomarker. Contract research organizations across the world have been using biomarker validation for years to better treatment standards. Now, advancements in the field of biochemistry and chemical engineering harbinger an incredible improvement in the field of clinical research. Scientists can today use biomarker validation, not only to identify biomarkers related to disease but also to identify patients, who are more likely to respond positively to a drug or treatment methodology.

It, therefore, stands to reason, that biomarker research and analysis require innovative approaches. The approaches have three main advantages of clinical biomaker

  • improve healthcare standards with innovative clinical research
  • reduce the cost of clinical trials
  • expedite newer therapies from the lab to market.

Let’s look at some of the major innovative approaches scientists and researchers can adopt for clinical biomarker research and analysis.

Genetic-centric research – Given the shift to genetic-centric approaches, the database of potential human volunteers will decrease during human trials. Therefore, new approaches become the need of the hour. Scientists need to use these biomarkers individually or collectively to create robust processes and capture the necessary data required for biomarker validation. Adopting ‘enrichment or adaptive designs’ in clinical trials, patients presenting the requisite response to biomarkers are enrolled in the study to create a treatment for a particular subpopulation or group of people is one way forward.

Discovering new biomarkers –

One of the biggest challenges scientists face is the relatively few numbers of biomarkers approved by the FDA. A focused approach to identifying new biomarkers is required. It may involve more intricacies to identify a new biomarker or validate the response of a biomarker. However, given their increase in clinical trials, the action will lead to a better understanding of diseases, especially to genetic markups. It will help create a larger pool of genes or characteristics for effective and quicker biomarker testing and analysis.

Understanding the effect of  clinical biomarkers

Epigenomic changes, three million base pairs and regulatory sequences are the challenges faced while researching molecular markers. Biomarker validation is possible when a marker contributes relevant, and quantifiable information for improving diagnostics accuracy and treatments efficacy. Recent research in genomics has pushed CRO services to create innovative trial designs focusing on the effect of a biomarker on the treatment response. Integration of Biomarker analysis with IPR – The pharmaceutical industry, in the US alone, accounts for nearly 45% of the global market at the cost of around $44 billion. Given the competitiveness of the field and the rewards one company can enjoy with a new drug or treatment method, the need to integrate Intellectual property rights with biomarker analysis and testing is necessary. While testing biomarkers, to either validate new treatments or identify a potential patient subgroup, the need to safeguard income interests should not be ignored. Advances in molecular sciences such as genomics and diagnostic technologies have created pathways to create better solutions within a shorter time frame and higher accuracy and efficacy!