Читать книгу Applied Biostatistics for the Health Sciences - Richard J. Rossi - Страница 33

Every well-designed clinical trial will have a predetermined research protocol that outlines exactly how the clinical trial will be conducted. The clinical trial protocol will describe what will be done in the trial, the rules for determining who can participate, the specific research questions being investigated, the schedule of tests, procedures, medications, and dosages used in the trial, and the length of the trial. During the clinical trial, the participants are closely monitored by the research staff to determine the safety and effectiveness of their treatment. In fact, the ethical treatment and safety of the participants are carefully controlled in clinical trials performed in the United States.

In general, a clinical trial run in the United States must be preapproved by an independent committee of physicians, biostatisticians, and members of the community, which makes sure that the risks to the participants in the study are small and are worth the potential benefits of the new drug or treatment. Many, if not most, externally funded or university-based clinical trials must be reviewed and approved by an Institutional Review Board (IRB) associated with the funding agency. The IRB has the power to decide how often to review the clinical trial, and once started whether the clinical trial should continue as initially planned or modifications need to be made to the research protocol. Furthermore, the IRB may end a clinical trial when a researcher is not following the prescribed protocol, the trial is unsafe, or there is clear and strong evidence that the new drug or treatment is effective.