Читать книгу Applied Biostatistics for the Health Sciences - Richard J. Rossi - Страница 32

Clinical trials are generally associated with biomedical research studies that are carried out on people for testing how well a new medical approach works, for testing the efficacy and safety of new drugs, for evaluating new biomedical procedures or technological advances, and for diagnosing, treating, managing, or preventing a disease. In the United States, a clinical trial is often highly regulated to ensure that it follows a well-designed research protocol that is ethical and preserves the safety of the participants.

For example, in the development of a new drug, a pharmaceutical company often begins by testing the drug on human cells and animals in a laboratory setting. If the initial laboratory research indicates that the drug may be beneficial to humans, the next step is to submit a new drug application (NDA) to the FDA. The NDA will contain information on the drug, the results of all prior test data on the drug, and descriptions of the manufacturing process used to make the drug. The FDA will then determine whether the drug is safe and effective for its proposed use(s), whether the benefits of the drug outweigh its risks, whether the drug’s proposed labeling is appropriate, and, if not, what the drug’s appropriate labeling is, and whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity. Supervised clinical trials represent the final testing ground for a new drug, and the results of the clinical trials will be used in the final approval or disapproval of a new drug.