| The United States Food and Drug Administration | | | | and reporting trials that involve human subjects"(2) as |
| (FDA) uses 'Good Clinical Practice' (GCP) to ensure | | | | well as setting up standards or recommendations of |
| 'good science'. According to the FDA website, "Good | | | | "ethical factors in the acceptability of foreign clinical |
| Clinical Practice is a standard for design, conduct, | | | | trials,"(2) "choice of control groups and related issues |
| performance, monitoring, auditing, recording, analysis, | | | | in clinical trials,"(2) and "acceptance of foreign clinical |
| and reporting of clinical trials."(1) In other words, the | | | | studies."(2) |
| FDA regulates the research and experiments done in | | | | The ICH has done something similar to what Linneus |
| the biomedical field. The FDA 'inspects and audits' the | | | | did when he "developed the concept of binomial |
| companies doing biomedical research and makes sure | | | | nomenclature."(3) Both have set up standards for |
| that they are practicing GCP. | | | | scientists. The ICH has set up standards for |
| The FDA, also, has the Bioresearch Monitoring (BIMO) | | | | international trials and Linneus has set up standards |
| program that investigates trials. The BIMO includes | | | | for scientists everywhere to understand one another. |
| clinical investigators, research organizations, and the | | | | I believe that this is all worthwhile for two main |
| institutional review boards (IRBs). The BIMO inspects | | | | reasons: |
| more than 1000 trials per year. They investigate | | | | 1. Regulating clinical trials keeps mistakes and other |
| clinical trials "that support applications for research or | | | | disciplinary problems to a minimum. |
| marketing permits for regulated by the FDA."(1) | | | | 2. International regulations make different products |
| On the international level, the FDA has been trying to | | | | available to other countries much quicker than if each |
| promote harmonization of regulations and | | | | product had to be tested by a different standard. |
| requirements in clinical trials. The International | | | | Footnotes: |
| Conference on Harmonization (ICH) was set up to | | | | (1)See: fda.gov/oc/gcp/default.htm for more |
| regulate the registration of the regions: Japan, United | | | | information on 'Good Clinical Practice' |
| States, and The European Union, for their | | | | (2)See: fda.gov/oc/gcp/guidance.html for more on |
| pharmaceutical products. They concluded that "Good | | | | the ICH. |
| Clinical Practice is an international ethical and scientific | | | | (3)See: gened.emc.maricopa.edu/bio/bio181/BIOBK |
| quality standard for designing, conducting, recording, | | | | BioBookintro. |