Chapter 9 - Drug testing

Abstract

Novel drug testing is a highly regulated process, overseen by the Food and Drug Administration (FDA) in the United States. According to the National Institutes of Health (NIH), 80%–90% of research projects fail before they reach human testing. The FDA supervises drug safety and efficacy testing before providing approval for clinical and commercial use, and for every drug that gains approval from the FDA, more than 1000 were developed and failed. During this process, the candidate drug goes through several stages of testing, from in vitro and animal models to human trials in academic and industry environments. This gradual transition from basic science to clinical trials ensures the large-scale efficacy and safety of drugs before commercial use. However, the translation process has challenges at each stage—ranging from formulating a poor hypothesis to inadequate transparency of the testing procedures. Researchers have advocated for modernized models and practices to enhance the efficacy and success rate of drugs under research by increasing teamwork and transparency. A major emphasis has been placed on revising traditional models for conducting biomedical research to acknowledge and monetize the work of academia and clinical researchers, and steps to encourage collaboration among researchers by compelling biomedical firms to soften their intellectual property rights may help increase success in drug testing.