| Coping with a chronic disease can be a difficult time | | | | the subjects nor the administrators are aware of |
| for everyone involved. Depending on the situation, | | | | which method of treatment a subject receives. This |
| patients can feel restricted by the lack of viable | | | | allows researchers to measure the effects of multiple |
| treatment options. One alternative method of | | | | treatments against each other. Phase 2 trials can last |
| therapy often explored is the use of experimental | | | | up to 2 years are conducted with subjects suffering |
| drugs. These drugs are categorized as medicines that | | | | from the target ailment. |
| have not yet be approved by the Federal Drug | | | | Phase 3 Trials |
| Administration (FDA) for consumer release. | | | | Phase 3 trials are similar to Phase 2 trials in that they |
| The FDA approval process for prescription medication | | | | are used to measure the effectiveness of the |
| can span 10 to 15 years depending on the medication. | | | | experimental drug on the targeted condition. The |
| This can be a substantial waiting period for patients | | | | difference between the two phases is that Phase 3 |
| who face limited windows of treatment for their | | | | is conducted with a much larger sample size and the |
| disease. By participating in the clinical trials of an | | | | trial period can last over 3 years. This longer trial |
| experimental medicine, the patient is afforded an | | | | period allows for the study of long-term side effects |
| opportunity to try new treatments that would | | | | and provides a better analysis of suitable dosage |
| normally not be offered. Though the nature of clinical | | | | ranges. Phase 3 trials also draw in-depth comparisons |
| trials comes with substantial risk, some patients are | | | | to existing drugs in order to measure the inherent |
| willing to assume this chance in hopes of finding a | | | | value of the experimental medication. The results of |
| cure. An important aspect in measuring this risk is to | | | | Phase 3 trials are used to determine accurate |
| understand the phases of testing. The four phases | | | | prescription dosages and consumer label information. |
| of clinical drug trials are examined below. | | | | Successful completion of this phase leads to an FDA |
| Phase 1 Trials | | | | submission for approval. |
| The goal of a Phase 1 trial is to measure the general | | | | Phase 4 Trials |
| safety and tolerability of the chemical compound. This | | | | The final phase of a clinical drug trial is used for |
| is the first step in determining the suitability of a | | | | further testing of the medication. While an |
| medication for use in humans. The research is | | | | experimental medication may not yet be approved in |
| focused on dosage thresholds and identifying side | | | | the early stages of Phase 4 testing, it is generally |
| effects, and typically last 6 to 12 months. Phase 1 | | | | deemed safe for targeted use. Even after the drug |
| trials are considered very unstable and risky. Because | | | | receives FDA approval, this phase continues as a |
| of this, they are normally carried out on healthy | | | | requirement by the FDA. Long term testing continues |
| adults. | | | | to evaluate to safety and effectiveness of the drug, |
| Phase 2 Trials | | | | and alternative uses of the drug are also examined. |
| The directive of a Phase 2 trial is to determine | | | | Phase 4 trials are also used to test different |
| whether or not the medication has the desired effect | | | | methods for administering the medication. Thus, this |
| on a particular condition. These trials are usually setup | | | | final phase of trials can produce significant changes in |
| as blinded experiments where multiple drugs and a | | | | the way a drug is used and how it is delivered. |
| placebo are randomized between subjects. Neither | | | | |