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“Key cost drivers of pharmaceutical clinical trials in the United States”

Clinical phase[edit]

Clinical trials involve three or four steps:[3]

  • Phase I trials, usually in healthy volunteers, determine safety and dosing.
  • Phase II trials are used to get an initial reading of efficacy and further explore safety in small numbers of patients having the disease targeted by the NCE.
  • Phase III trials are large, pivotal trials to determine safety and efficacy in sufficiently large numbers of patients with the targeted disease. If safety and efficacy are adequately proved, clinical testing may stop at this step and the NCE advances to the new drug application (NDA) stage.
  • Phase IV trials are post-approval trials that are sometimes a condition attached by the FDA, also called post-market surveillance studies.

The process of defining characteristics of the drug does not stop once an NCE begins human clinical trials. In addition to the tests required to move a novel drug into the clinic for the first time, manufacturers must ensure that any long-term or chronic toxicities are well-defined, including effects on systems not previously monitored (fertility, reproduction, immune system, among others). They must also test the compound for its potential to cause cancer (carcinogenicity testing).

If a compound emerges from these tests with an acceptable toxicity and safety profile, and the company can further show it has the desired effect in clinical trials, then the NCE portfolio of evidence can be submitted for marketing approval in the various countries where the manufacturer plans to sell it. In the United States, this process is called a “new drug application” or NDA.

Most NCEs fail during drug development, either because they have unacceptable toxicity or because they simply do not have the intended effect on the targeted disease as shown in clinical trials.

A trend toward the collection of biomarker and genetic information from clinical trial participants, and increasing investment by companies in this area, led by 2018 to fully half of all drug trials collecting this information, the prevalence reaching above 80% among oncology trials