Biomarker

Biomarkers provide a dynamic and powerful approach to understanding the spectrum of disease with applications in observational and analytic epidemiology, randomized clinical trials, screening, diagnosis and prognosis. Biomarker is defined as alteration in the constituents of tissues or body fluids, these markers offer the means for homogeneous classification of a disease and risk factors, and then can extend our base information about the underlying pathogenesis of disease. A prerequisite for the clinical use of biomarker is elucidation of the specific indication, standardization of analytical methods, characterization of analytical features, incremental yield of different markers for given clinical indications. Biomarkers can also reflect the entire spectrum of disease from the earliest manifestations to the terminal stages. The major use of biomarkers has been employed  in clinical investigation. The article features biomarkers in drug development and in disease diagnosis.

Biomarkers are considered as tremendous gift of modern biomedical sciences to improve the outcome for people with cancer by enhancing detection and treatment approaches.  Biomarkers could include a broad range of biochemical entities, such as nucleic acids, proteins, lipids, small metabolites, as well as whole cells or biophysical characteristics of tissues. Detection of biomarkers can be accomplished by a wide variety of methods, ranging from biochemical analysis of blood or tissue samples to biomedical imaging. The primary focus of this review article is to find out the role of biomarkers as invaluable tools for cancer; specially breast and cervical cancer detection, diagnosis, patient prognosis and treatment selection. Besides, the future trend of biomarker development for these two types of cancer is also discussed.

Biomarkers and surrogate endpoint largely replaced the clinical trials which are needed to be carried out before drug approval in regular approval process under FDA (Food and Drug Administration), a governing pharma regulatory body in USA and as a result approval process can be accelerated. It can be said that surrogate endpoint and biomarker are substituting the clinical trials and decrease the duration of product development phase as well as decrease the entry time period of novel products in the market. The article enlightens the extent to which the biomarkers and surrogate endpoint have benefited the pharma industry for expediting the entry of their products into the market at the earliest to get the maximum benefit of the product during the patent period. Simultaneously article also throws light on the history of risk factors of surrogate endpoint which are likely to jeopardize the interest of the human beings involved. It may conclude that Biomarkers and surrogate endpoints play pivotal role in accelerating approval process for drug approval in USA and the usage of these parameters to minimize the casualty of human lives who are suffering from serious life threatening diseases by providing recent research products which have caliber to cure or improving the quality of life. Key words: Clinical trial, Biomarker, Surrogate end point, Accelerated approval, Caliber to cure, Casualty of human lives.