Clinical trials conducted in Northwestern Arkansas are often conducted in a series of steps, called "phases." Each clinical trial is conducted in order to determine the safety or effectiveness of a new drug or procedure. The final result of all phases of a clinical trial is the approval of the drug or treatment by the U.S. Food and Drug Administration (FDA) and ongoing monitoring of its safety and effectiveness.
Phase 1: Determining the Safety of the Treatment
At this point, the drug or procedure has already been tested on animals and is reasonably believed to be safe for humans. Phase 1 trials are composed of small groups of people (usually less than 50) called "cohorts." During phase 1, researchers are attempting to determine the following:
* Is the new treatment safe for humans?
* What is the best method for administering the treatment?
* Are there any signs the patient's condition is responding to the treatment?
Phase 2: Determining if the New Treatment Works
After determining the most effective method for administering the treatment in Phase 1, researchers administer the treatment and see if it provides any benefits. The number of people participating in Phase 2 is usually no more than 100. Phase 2 clinical trials examine the safety of a treatment more extensively than Phase 1. During Phase 2, researchers are also attempting to determine the following:
* Does the treatment lead to a better quality of life?
* Do the benefits of the treatment outweigh the side effects?
* Does the condition disappear completely, or does it take longer for the condition to
return?
If enough participants benefit from the treatment and the benefits of the treatment outweigh the side effects, then the clinical trial moves on to Phase 3.
Phase 3: Determining if the New Treatment is Better than the Standard Treatment
A Northwest Arkansas Cancer Treatment clinical trial that moves on to Phase 3 may be conducted on thousands of participants throughout the United States and possibly the world. Phase 3 is the final phase before a treatment is approved by FDA.
During Phase 3, tens and thousands, or more, of participants are randomly assigned to various study groups, and the study is performed in a "double-blind" manner. "Double-blind" means that neither researchers nor participants know who is receiving the treatment and who is receiving a placebo. Studies that are double-blind and that involve random assignment are considered to be the most reliable and valid studies, as they have the highest chance to be free from bias.
Participants are monitored closely in order to determine if the new treatment is more effective than the standard one.
Phase 4: How Safe is the Treatment in the Long-Term
At this point, treatments have already been approved by the Food and Drug Administration. However, their long-term effects are still not known and require ongoing study. Phase 4 trials are less common and typically involve hundreds and thousands of people.
Phases 4 clinical trials may also study whether or not the treatment may have other uses.
HTML Ready Article. Click on the "Copy" button to copy into your clipboard
