How Are Cancer Treatments Used in Clinical Trials?
You may assume that any treatment can go through a clinical trial. After all, isn’t the point of a clinical trial to test the treatment to determine its effectiveness and safety? So, wouldn’t this mean that any new treatment should be able to qualify for a clinical trial? Surprisingly, this is far from the case. Before any new treatment has the green light to partake in a research study, certain questions must be answered – and they must be answered correctly.
Important Questions
Since patients will be volunteering to contribute to the study, it is important that it remains ethical for people to do so. After all, as a new treatment, there is really no telling what could happen. The study itself must prove that it has taken people’s safety into consideration as much as possible. Is the study safe? It is also important to prove that the volunteers receiving the new treatment have been given something that is at least as good as something they would have been given had they not participated in the clinical trial in the first place.
Pre-Clinical Studies
Pre-clinical studies are carried out prior to the clinical trial going live. This involves studies that prove the new treatment is not harmful to people. Cell studies, for example, are usually the first type of pre-clinical study. Cancer cells are grown in a test tube or lab dish to determine the effects of the new treatment. Cell studies can be carried out on either animal or human cancer cells and provide the initial building block towards finalising the clinical trial approval for new treatments.
The next stage in the pre-clinical study process involves animal studies. According to Cancer.org, the treatments that made the best progress in the cell studies phase are then tested on living animals who have cancer. The main purpose of this stage is to test how safe the new course of treatment is when used in a living creature.
Once the pre-clinical studies have been completed to meet the FDA’s high standards, permission is then given to allow the treatment to be tested in humans during a clinical trial. Once the treatment has reached this stage, the clinical team will usually hire Clinical Trial Assistants from http://www.gandlscientific.com to help with the administrative and other important tasks to be completed such as maintaining the clinical systems etc.