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What are the various types of Clinical Trials in which an intervention is given to determine...

What are the various types of Clinical Trials in which an intervention is given to determine its effect on a certain disease or health condition?

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Expert Solution

There are two main types of tests or studies - traditional and observational.

Traditional testing aims to obtain more information about a specific intervention or treatment. Participants were placed in different treatment groups so that the research team could compare the results.

The purpose of observational studies is to find out what happens to people in different situations. The research team will check the participants, but they will not affect any treatments for the public. Participants are not placed in treatment groups.

There are different types of testing in these two groups. Information about this page

A pilot study and feasibility study

Preventive testing

Screening Trial

Treatment test

Multi-arm Multi-Stage (MAMS) Trial

Coordination studies

Case-control study

Cross-sectional studies


A pilot study and feasibility study
Pilot studies and feasibility studies are smaller versions of studies that sometimes take place before the big tests.

The feasibility study is designed to see if it is possible to conduct a major study. Their purpose is to ensure that patients and physicians are willing to participate and how long it takes to gather and analyze information. For example, they do not answer the main research question of how effective the treatment is.

Pilot studies are small-scale versions of the main study. The pilot study helps to check whether all the major parts of the study work together. They can also help answer research questions. Sometimes the main study results of the research team include information gathered during the pilot study.

Preventive testing
Preventive tests look at whether a particular treatment helps prevent cancer. Participants did not have cancer.

These tests may be for the general population or for those who are at a higher risk of developing particular cancer. For example, this may include people with family history.

Screening Trial
Screening means screening people for early signs of cancer before any symptoms occur. As with preventive testing, screening tests may occur for the general population. Or they may belong to a group of people who have a higher risk of developing particular cancer.

Researchers can plan screening tests to see if new types of tests are reliable enough to detect specific types of cancer. Or they may try to find out if there is an overall benefit to getting cancer early.

Treatment test
The treatment test is called steps. The early stages aim to gain more knowledge about the safety and side effects of the new treatment. The next step is to see if the new treatment works better than the current one.

For trials comparing two or more treatments, participants were randomly placed in the treatment group. Randomized treatment trials are the best way to get reliable information about how the new treatment works. We have more information about randomization.

Multi-arm Multi-Stage (MAMS) Trial
The multi-arm test is a test that includes multiple treatment groups (hands) as well as standard treatment groups (control groups).

Single control group by multi-arm multi-stage (MAMS) tests. Other treatment groups may change as the trial progresses.

The research team may decide to stop assigning people to a specific group. This may be because they have enough people to see the results. Or preliminary results suggest that treatment is not working as they had hoped.

They can add new treatment groups as new drugs become available to view. Every time they want to research a new treatment, they have to create and start a new trial. So it helps to bring results quickly.

The routing test for prostate cancer is an example of the MAMS test.

Observational studies
Cohort studies, case-control studies and cross-sectional studies are all types of observational studies.

Coordination studies
Coordination is a group of people, so the study of coordination looks at groups of people. A cohort study follows the group over a period of time.

A research team can recruit people who have no cancer and they can collect information about them for years. Researchers see who develops cancer and who doesn't. They want to see if they have something in common with people who have developed cancer.

Cohort studies are very useful ways to get more information about risk factors. But they are expensive and time-consuming. They can be used when a theory cannot be tested otherwise.

Case-control study
Case-control studies work differently for studies. The research team employs a group of people with a disease (cases) and a group of people who do not (control). They fall back to see how many people in each group are exposed to a certain risk factor.

Researchers want to make the results as reliable as possible. So they try to make sure that people in each group have common factors like age or gender.

Case-control studies are useful and they are faster and cheaper than coordination studies. But the results may be less reliable. Research teams often rely on people to think back and remember whether they have been exposed to a particular risk factor. But people may not remember exactly and this can affect the results.
Another problem is the difference between association and reason. Just because there is a relationship between a cause and a disease, does not mean that the causation is a cause of disease.

For example, a case-control study shows that low-income people are more likely to get cancer. But this does not mean that income levels can cause cancer. This means they have less food or are more likely to smoke.

Cross-sectional studies
Cross-sectional studies can be done at a time or in a short period of time. They will find out who is at risk, who has developed cancer, and see if there is a link.

A cross-sectional study is quick and inexpensive. But the results may be less useful. Sometimes researchers first study a cross-sectional study to find a possible link. Then they study to control the subject or see the problem in more detail.


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