What is Clinical Research?
Clinical research is a form of medical research which involves the study and use of human subjects to further scientific knowledge. One of the most classic forms of clinical research is the clinical trial, in which a group of patients are used to test a new medication, treatment, or device. Because this type of research involves the use of human subjects, it is accompanied with a number of legal and ethical issues, and studies must be carefully vetted by ethics committees and government organizations which supervise medical research.
People can conduct clinical research for a number of reasons. It may be used to test a new treatment or approach to disease, which can include preventative care, advanced screening techniques, new diagnostic methods, or supportive care for people with terminal illness. The research can also be used to gather demographic information about particular groups of people, or in epidemiology studies which track the spread of disease through various human populations.
In addition to using actual humans, clinical research can also involve samples of tissue from living humans. The tissue may be healthy or diseased, and it can come from a variety of sources, ranging from pathologists to voluntary donors. A cancer researcher, for example, might work with samples of various cancers from real patients, usually with identifying information obscured for patient privacy and to ensure the integrity of the trial.
When a researcher puts together a clinical study, he or she must provide justification for the study, showing that it is necessary, and he or she must show how patients in the study will be cared for and protected. Informed consent is usually critical, so that patients involved in clinical research understand exactly what is going on and how they may be affected by the trial, as are ethical reviews to determine that the nature of the study does not cross ethical boundaries.
For universities, government health agencies, and scientific laboratories, this type of research is critical to the advance of the sciences and medicine. Clinical research is constantly ongoing all over the world to give researchers more insight into a variety of issues, from the safety of a new eczema drug to the best palliative care for cancer patients. Patients who participate in clinical research can sometimes get access to state of the art treatments and health care, while also bettering the cause of humans as a whole. Information about ongoing trials is often available from doctors and academic institutions which perform clinical research.
When I was a few months pregnant with my daughter, the university in my area asked me and my baby to be a part of a study on health and pregnancy.
I was interviewed two times during pregnancy about my habits - like smoking, drinking, coffee drinking and others. Then I was asked to bring my daughter into a doctor for various tests (no chance of any harm.) She was part of a very large study group. I brought her in at periodic intervals for six years. Some of the time she also visited a psychologist.
It was very interesting to do this and they gave me some of the data they had learned about habits during pregnancy and the later health of the children.
I was glad to help out in the search for more information about health of children and pregnancy.
Clinical studies with a control group, who receive no medication or treatment, and a group who does receive treatment is one of the best ways to get more conclusive evidence. But the study should be repeated over several times to be conclusive. I feel that these studies should be monitored very carefully.
If I was very sick and nothing was working, I might agree to be a part of a study group, in hopes that the treatment might be effective. But there's always the chance that you would be in the control group and just get a placebo.
These clinical research trials are what keeps knowledge about medications and treatments going. It's commendable that so many people agree to participate.
@strawCake - As you said, all the participants sign waivers and releases. No one is making them participate! I don't think there is anything unethical about clinical research at all!
Plus, from what I've read, a lot of times the ill people who are participating can't be helped by any other medicine. So they at least have a chance of maybe getting better if they participate in the trial.
I actually think that clinical trials on people who are ill are completely unethical. Yes, they try to make them ethical and people sign releases. That doesn't make a different to me.
A lot of sick people participate in clinical studies in hopes of curing their illness. Most studies have a control group that doesn't get any medicine at all-they just get a placebo. That means that people who could have been getting some other kind of treatment for their illness are getting no treatment at all, all in the name of research. This is very unethical to me.
I remember when I was thirteen, my mother participated in a clinical trial. I recall going with her to her exams.
Every time she went, the doctor would ask her if she could tolerate the same dosage of the drug for the remainder of her life. She always said yes. I’m sure that was an important factor in deciding whether the drug was fit to market or not.
They also asked her each time about all of her medications and if she had any new ones. They told her she could not get pregnant during the study, and I was bummed about this, because I wanted a little sister or brother.
I once took part in a clinical trial to treat a chronic condition that I have. The tests the study doctors conducted were not very invasive, so I didn’t mind them.
They took my blood and had me pee in a cup every four months. They also checked my blood pressure and pulse. Once a year, I had to have an MRI so that they could see how the drug was affecting my organs.
The hospital where the study was being conducted was five hours away from my home, so the drug company agreed to pay for my mileage in addition to the money they regularly give out just for participating. I ended up with more money than I actually needed for the trip, so that was nice.
My sister took part in a clinical trial involving a new weight loss drug. They warned her of the side effects, but she thought she could handle them.
They told her that this drug was a diuretic, so it would make her urinate a lot more frequently. She would feel very thirsty and have to drink a lot to stay hydrated.
She got to the point where she was going to the bathroom once every hour. She took bottled water with her everywhere she went.
Despite this annoyance, she continued participating. She said the pay was too good to pass up, and she also was shedding pounds.
I am involved in an ongoing clinical trial for the drug Tolvaptan. The study is examining its effect on people with polycystic kidney disease. Though the drug is already being used to treat heart conditions, it has not yet been approved for treating my kidney condition.
I have been in the study for three years, but at this point, I do not know if I am taking the real drug or a placebo. Within a few months, this phase of the study will end, and a new study will begin in which all the participants will be given the real drug. It will be interesting to see if I can tell any difference.
@Charred - I used to think that all drugs were tested on laboratory animals and no more. But I guess before releasing medication out to the marketplace, clinical research education would have to involve some testing on human subjects.
Personally, it’s not for me. I don’t like the idea of being a human guinea pig for something that’s still in its experimental stages, for any amount of money. But to each his own I guess.
@allenJo - I know of some college students who have helped to pay their way through college by participating in some of these studies. You do get paid well, as you said, but I don’t recommend that you get involved in too many of these clinical research program trials.
With each program you become a part of, you increase the likelihood that you will incur side effects. It kind of reminds me of people who make money on the side by donating plasma. Once or twice is okay, in my opinion, but doing it on a regular basis will cause you real problems.
Some people who give plasma constantly have reported cases of dizziness and things like that. There are certainly better ways of making money, I would think.
A guy at my workplace took part in a clinical trial for a new drug pressure medication once. He said they offered him $500 to become part of the study, which was certainly fine with him.
As the article says, however, he had to sign all of these releases so that he would promise not to sue the research facility if some bad side effects happened to him. He said that the possibility of side effects was very small; they happened in a very small number of the cases.
Nonetheless, the possibility always exists, so he had to sign the releases. Also they kept him in the hospital for two days afterwards to monitor his condition, all at their expense.
@Cupcake15 - Involving a minor child in a research study like this is a little crazy if you ask me. Many of these drugs are experimental in nature and do pose risks especially on young children. I can see someone that has a terminal illness that wants to participate in a study like to this to see if it may prolong their life or even offer something that will halt the progression of their disease, but to have a young child participate in a clinical research program is something different.
I think that it is great that there are a lot of clinical research trials out there in order to find better ways of dealing with different diseases. While there are risks with becoming involved in clinical trial research, the reward really comes from the clinical research investigators developing a drug that will be able to eradicate or treat the symptoms of many diseases that will offer a better quality of life for most people.
There was a study recently that I saw that were looking for volunteers in order to improve the symptoms associated with Type 1 Diabetes in children ages ten and up. The study wanted to find ways to control the diabetes as well as monitor the depression symptoms that also coexisted.
A neighbor of mind is going to have her daughter participate in the study. She said that the study will last one year and she will be compensated for her daughter's participation.
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