clinical trials - briefed
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clinical trials - briefed
Admin on Fri May 30, 2008 10:47 am
Clinical trials are people-based studies — as opposed to animal or lab studies — of new drugs or procedures. Doctors use clinical trials to learn whether a new treatment is safe and effective in patients. Such studies are vital to the development of new treatments for diseases such as cancer. The doctors in charge of a clinical trial don’t know ahead of time how things will turn out. If they did, there would be no need for the study in the first place.
Most people don’t pay much attention to clinical trials until they are diagnosed with a serious illness such as cancer. Medical breakthroughs (the results of clinical trials) often make the news, but you usually don’t hear about clinical trials themselves unless something has gone wrong in a clinical trial. The media is quick to pick up on an instance when a volunteer in a study is harmed. While it is very rare, people have been harmed, and have even died, while taking part in clinical trials. Reports of these tragic outcomes are important, because they help to expose problems in the system, which are then corrected to protect others. What you usually don’t hear about, however, are the thousands of people who are helped each year because they decided to take part in a clinical trial, not to mention the millions who ultimately benefit from others’ participation in clinical trials. There is no right or wrong choice when it comes time to decide on taking part in a clinical trial.
The decision is a very personal one and depends on many factors, including the benefits and risks of the study, what the person hopes to achieve by taking part, and other preferences. Knowing all you can about clinical trials in general — and ones you are considering in particular — can help you feel more at ease with your decision. If you do decide to participate, knowing what to look for and what to expect ahead of time can help you. This guide should address many basic questions and concerns so that you are better prepared to discuss the subject with your doctor and family. It should clarify which questions need to be asked beforehand and what the answers may mean for you. In the end, however, only you can decide if taking part in a clinical trial is right for you.
Clinical trials show us what works (and what doesn’t) in medicine. They are the best way for doctors to learn what is safe and effective in treating diseases such as cancer. Some doctors and scientists conducted what would now be considered clinical trials as far back as the late 1700s, but clinical trials were not widely used until the middle of the 20th century. Up until that time, doctors relied on their own experience in particular cases and on the teachings of those who came before them. Progress was slow, and very few medicines existed that could even be tested.
With the discovery of the first antibiotics and other drugs, doctors needed a reliable way to tell what worked from what didn’t. They also needed ways to find out which of the countless remedies available at that time were safe for people to use. So they developed studies that tested, and often compared, treatments in a specific group of people. The results of these clinical trials proved to be more useful than relying on whether or not something worked in one or a few people.
In the US, new drugs and medical devices (but not dietary supplements) must be approved by the US Food and Drug Administration (FDA) before they can be advertised or sold to the general public. The FDA began overseeing the safety of new treatments in the late 1930s but didn’t require proof of effectiveness until the early 1960s. Today, drugs and medical devices must go through several phases of clinical trials before being approved for use. Based on what we have learned about cancer in recent years, researchers can now develop new treatments in a more logical way and much faster than in the past. But it’s still a time-consuming and difficult process.
Clinical trials are only a small part of the research that goes into developing a new treatment. Potential drugs, for example, first have to be discovered, purified, characterized, and tested in labs (in cell and animal studies) before ever reaching clinical trials. In all, about 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial.
Watch out for more on the Clinical Trial Phases,Placebos etc….
Most people don’t pay much attention to clinical trials until they are diagnosed with a serious illness such as cancer. Medical breakthroughs (the results of clinical trials) often make the news, but you usually don’t hear about clinical trials themselves unless something has gone wrong in a clinical trial. The media is quick to pick up on an instance when a volunteer in a study is harmed. While it is very rare, people have been harmed, and have even died, while taking part in clinical trials. Reports of these tragic outcomes are important, because they help to expose problems in the system, which are then corrected to protect others. What you usually don’t hear about, however, are the thousands of people who are helped each year because they decided to take part in a clinical trial, not to mention the millions who ultimately benefit from others’ participation in clinical trials. There is no right or wrong choice when it comes time to decide on taking part in a clinical trial.
The decision is a very personal one and depends on many factors, including the benefits and risks of the study, what the person hopes to achieve by taking part, and other preferences. Knowing all you can about clinical trials in general — and ones you are considering in particular — can help you feel more at ease with your decision. If you do decide to participate, knowing what to look for and what to expect ahead of time can help you. This guide should address many basic questions and concerns so that you are better prepared to discuss the subject with your doctor and family. It should clarify which questions need to be asked beforehand and what the answers may mean for you. In the end, however, only you can decide if taking part in a clinical trial is right for you.
Clinical trials show us what works (and what doesn’t) in medicine. They are the best way for doctors to learn what is safe and effective in treating diseases such as cancer. Some doctors and scientists conducted what would now be considered clinical trials as far back as the late 1700s, but clinical trials were not widely used until the middle of the 20th century. Up until that time, doctors relied on their own experience in particular cases and on the teachings of those who came before them. Progress was slow, and very few medicines existed that could even be tested.
With the discovery of the first antibiotics and other drugs, doctors needed a reliable way to tell what worked from what didn’t. They also needed ways to find out which of the countless remedies available at that time were safe for people to use. So they developed studies that tested, and often compared, treatments in a specific group of people. The results of these clinical trials proved to be more useful than relying on whether or not something worked in one or a few people.
In the US, new drugs and medical devices (but not dietary supplements) must be approved by the US Food and Drug Administration (FDA) before they can be advertised or sold to the general public. The FDA began overseeing the safety of new treatments in the late 1930s but didn’t require proof of effectiveness until the early 1960s. Today, drugs and medical devices must go through several phases of clinical trials before being approved for use. Based on what we have learned about cancer in recent years, researchers can now develop new treatments in a more logical way and much faster than in the past. But it’s still a time-consuming and difficult process.
Clinical trials are only a small part of the research that goes into developing a new treatment. Potential drugs, for example, first have to be discovered, purified, characterized, and tested in labs (in cell and animal studies) before ever reaching clinical trials. In all, about 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial.
Watch out for more on the Clinical Trial Phases,Placebos etc….
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