PHASE 0 CLINICAL TRIAL: HOPE THROUGH RESEARCH

Abstract

This paper Development of a drug molecule has always been a long and an exclusive process. From preclinical to clinical testing, it takes almost 10-15 years with an expense of almost US$2 Billion. It has been observed that serious challenges faced by researchers resulting in highest rate of failure in development of new drug molecules in clinical research. Seeing these grievances, the US FDA in 2004 introduced a “Critical Path “document highlighting the major decline of the drug development process despite having new advances and technology in biomedical research and the majors to improve the quality and effectiveness of overall drug discovery and development process. Thus, in 2006 a new guidance was issued on Exploratory IND studies by US FDA which is called phase 0 clinical study. It uses the concept of micro dosing. Minimum 30-40% of drugs fail in phase 1 trial due to unfavorable pk and pd. Micro-dosing is a new toolkit used in the drug development process and includes low or minute intake of molecules hardly to show any pharmacological effect when administered by participants and thus, helps in evaluating pk profiles. It shows no therapeutic effect, so chances of adverse reactions are also low. It acts as a bridge between preclinical and clinical study and can be beneficial in reducing extensive use of animal testing. Human screening is conducted to enroll few healthy participants for minimal no. of 7 days for the conduction of phase 0 trial. With recent technology, research and development and advancement, micro dosing has become more and more revolutionary and is emerging as the dormant challenge to be enormously used in more and more drug development process and make a shift to the process in a positive direction. The First emerging development of phase 0 trial can be witnessed in successful oncology trial in patients with progressive malignancies. Results proved to show a good and a well-tolerated bioavailability, and a desirable pharmacokinetics and biochemical data and hence this evidence can be used further to guide the development process and improve the drug development scenario.