Research is important because it helps medical professionals understand the nature and causes of mesothelioma, which leads to new forms of treatment that are better able to control the spread of the disease.
The most common form of research is the clinical trial. These are studies using human subjects that followed a pre-determined protocol. The protocol is a written document that describes the questions the researchers are trying to answer, the method they will use to find those answers, what types of people they want as participants in the study, the kinds of tests, medical procedures and medications that will be included in the study, and how long the study will last.
Clinical Trials are Usually Broken Down into Three Types:
- Interventional studies – In this kind of trial, participants can be randomly assigned to receive the intervention, which is the type of treatment or drug being tested; or they can be assigned to be part of the control group. The control group receives the current accepted treatment or they are given a placebo, which is pill that looks like the drug being tested, but has no treatment value. The control group is important because they serve as the comparison for the group given the intervention so that an evaluation can be made about the effectiveness and safety of what is being tested. This type of study is referred to as “double blind” because the doctors and nurses connected with the study have no idea which participants are in the intervention group and which participants are in the control group.
- Observational studies – Researchers examine existing data about individuals already receiving a treatment or drug and compare it with a group of people who aren’t using it. The comparison group is demographically similar to the group receiving the treatment/drug. The purpose of this kind of study is to observe the effect of the treatment/drug in the general population instead of in a controlled environment.
- Case-control studies – This is used to test the possible relationship between a factor and a medical condition by comparing the cases, or participants who have that condition and the factor against the controls, participants who are demographically similar and have the factor, but not the medical condition.
Clinical Trials Start out Small and Eventually Expand the Group Tested
Researchers test in phases. Each phase of a study has a different objective.
- Phase I trials use a small group participants, usually less than 100 people, so that the researchers can determine if it is safe to continue testing, how large a dose of the drug can be administered and whether or not there are side effects.
- Phase II trials expand the number of participants receiving the drug or treatment to between 100-300 participants to continue testing for safety and effectiveness.
- Phase III trials test the experimental drug or treatment on a much larger population. This is done to confirm the results from the other two phases and to compare the experimental drug/treatment against what is currently being used to see if it is a better alternative.
- Phase IV trials are conducted after the drug has been marketed in order to gather additional information including side effects that were not apparent in other testing phases, risk factors that may make the drug harmful to certain populations, and the most effective use of the drug/treatment.