Major Causes Associated with Clinical Trials Failure and Selective Strategies to Reduce these Consequences: A Review

New drug development is a highly regulated and complex process that involves the pharmaceutical industry, academic institutions, and government agencies' collaborative work. In pre-clinical testing, statistics indicate that out of 5000 compounds only five enter and evaluated in human clinical trials, moreover, only one drug is approved for human use. The whole process of drug development takes around $2-2.5 billion and a time of 12-15 years to complete. Around 50% of investigational compounds fail during the development phase of clinical trials. Despite numerous scientific and technological advancements in research and development, many clinical trials fail to develop new, safe, and effective drugs. Approximately, 70% of clinical trials fail in phase 2; whereas, the failure rate of confirmatory trials (phase 3) is around 50%. Tufts center for the study of drug development evaluated the three most common factors behind clinical trial failure-safety, efficacy, and deficient funds. Success-failure of a trial is also associated with other factors like a new molecule, molecular size, and therapeutic efficacy. As drug development involves numerous lives and billions of investments, one failed trial affects the subject’s quality of life by physical/social consequences and huge losses to pharmaceutical companies. To reduce the failure rate, many biopharmaceutical companies have opted or established their own more disciplined protocol, portfolio, and progress review frameworks. These strategies reduce the chances of errors during drug development and help in clinical trials' success rate.

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