Advances in Clinical Trials

Clinical trials are the clinical investigation of a drug that administered or dispensed to, or used involving one or more human subjects. Clinical trials are the major parameter for the approval of drug, as they mainly deals with the effectiveness and safety.  Clinical trials plays a vital role in the development of new drug entity as it subjected to various phases for approval . Advancements in  clinical trials enhances the drug development process by means of reducing time duration, sometimes the cost.

The success rate of Phase II trials that proceed to Phase III, as of 2010, is 18%. The amount of money spent on Phase II/III trials in 2015 by Large Sponsors (R&D $500M+) was $465,725,000 on average, while Non-Large Sponsors (R&D <$500M) spent $13,352,000 on average. The entire process of a drug from lab to this point may take approximately 12 to 18 years (but not always), often costing over $1 billion.

  • Role of Clinical Trials
  • Goals of Preclinical studies
  • Safety potential results of Preclinical studies
  • Overcoming hurdles in Clinical Trials
  • Meeting the requirements of FDA review process
  • Safety and Effectiveness of Drug

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