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Participating in a Cancer Clinical Trial: How will you be safe?




Clinical trials are tests to approve drugs or treatments that are able to detect or diagnose a specific disease. Doctors use these clinical trials to see if their medicine works, and how it might affect the health of the public. Cancer clinical trials, in specific, can take months, if not years to complete and being able to pull out important data is usually very hard.

Clinical trials are only done after preclinical research shows that the new treatment may be effective in people. Preclinical studies, also called lab studies, are first done on individual cells. If that stage is successful, it is then tested on animals such as mice and rats. This is especially important because it shows researchers how their medicine might react in living creatures. Even though lab studies give doctors and scientist a lot of information, it is still important that they test it out in a select group of people, because the way mice absorb medicine is different from people. Before they do this however, they must get approval from the FDA (US Food and Drug Administration). And rest assured, since the FDA Approval process is not easy. The IND (investigational new drug) application form requires results from the lab study, what's in the drug and how its made, detailed outlines for study protocols (to make sure people aren't uselessly exposed), and details about the clinical team to make sure they have the expertise to run the trials. As you can tell, not every drug is approved by the FDA. A recent study shows that only 5 in 5,000 drugs are approved by the government. After getting approval, the drug is given to certain people and then the public. At this point, most of the research is going to be other aspects of the treatment such as cost effectiveness or quality and length of life.


Even in a clinical trial, there will be ways that you are protected. Many people, such as IRBs (Institutional Review Boards), DSMBs (Data Safety Monitoring Boards), and the clinical investigator, will be constantly monitoring the clinical trial to make sure everything is running smoothly. All of these people are constantly monitoring data and outcomes to make sure that the risks are not greater than the benefits and they know that the safety of the test subjects are priority. There are also certain government agencies, such as the FDA (US Food and Drug Administration), OHRP (Office of Human Research Protections), and the NCI (National Cancer Institute), that makes sure that the clinical trials are valid and that test subjects will be protected. If your trial is for a good cause, one of these agencies might even fund your research.


Unfortunately, since this is a rather new field of work, and this is a new system, there are many risks to this process. Since this is a trial, it is obviously not proven to work which may mean that the treatment is ineffective and may lead to serious side effects. Although there are great benefits that will generally balance this out, you must not underestimate the risks and you have to think through them very carefully. Another con to participating in a clinical trial is the frequent trips and stays at the hospital which can be quite time consuming and costly. Recovering from your disease might be worth this cost, but sometimes you are given a placebo instead of the active new drug. A placebo is a "fake" medicine which is sometimes used to see if the result was actually because of the new treatment or because of some other factor. Although it is unethical to do this without consent, some types of cancer have no known treatment, and placebos are given along with the actual treatment. In this case, the very least you should expect, is that the researchers should tell you whether they will be giving a certain group a placebo.


Although there are many cons for clinical trials, it is a key part of research, and a must before releasing new medicines. Remember that people who participate in clinical trials probably have their own reasons and that it is totally OK as long as the researchers behind the trial have a done a good job. Hopefully, scientists and doctors will come up with a way to test their drugs on robots or other new inventions before coming to the public.


Sources:

https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html


https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/protection-for-study-participants.html


https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/who-does-clinical-trials.html


https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/what-does-a-clinical-trial-involve.html

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