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Omics Approaches and Applications in Clinical Trials

  • Sanjeev Sharma
  • Anjana Munshi
Chapter

Abstract

Clinical trials are aimed at compiling evidence of efficacy and safety through the use of drugs in a large number of patients. Large numbers are required to overcome the issues such as disease heterogeneity, partial understanding of the underlying disease mechanisms, and variability in drug response adverse drug reactions. Due to poor efficacy and suboptimal safety, the failure rate of potential products in development is more than 90 %. This pipeline attrition has an enormous cost – both financially and time-wise.

Novel approaches and tools of omics, especially “pharmacogenomics,” have enabled exploration of the molecular mechanisms underlying differences in drug response and thereby reduce attrition. After the sequencing of human genome, genomic information has benefitted the mankind in a number of ways. The stratification of patients based on their genotype, thus prevents the occurrence of severe drug reactions and better clinical outcome in susceptible patients, is one of the few examples of use of genomics in the area of health care. Pharmacogenomics identifies safety biomarkers and provides an opportunity to rescue a compound that would otherwise fail to be commercialized due to safety concerns. Further the knowledge of pharmacogenomics along with bioinformatics during different phases of clinical trials will formulate the drugs with more therapeutic effectiveness and with minimum adverse effects. This will also reduce the cost of adverse drug reactions being experienced by the patients and chances of withdrawal of the drug molecule from the market.

Keywords

Epidermal Growth Factor Receptor Human Leukocyte Antigen Drug Response Poor Metabolizers Drug Development Process 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer India 2013

Authors and Affiliations

  1. 1.Department of Clinical PharmacologyApollo Health CityHyderabadIndia
  2. 2.Department of Molecular Biology, Institute of Genetics and Hospital for Genetic DiseasesOsmania UniversityHyderabadIndia

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