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What Makes Clinical Studies So Important

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Medical research studies are an important way of advancing our medical knowledge. Medical research studies are done to ensure that any new treatment is both effective and safe, and there are a number of reasons why they are critical to our understanding.

Medical Research Studies Are About Probability

It may seem strange to hear, but no study can prove with complete certainty that one thing causes another. Instead, clinical trials help us understand what things are most likely linked. As an example, most people probably believe that smoking causes cancer, and that this is a proven fact. Actually, no medical study has or could ever prove this to be a fact. But medical studies can show that the links between two things–such as smoking and lung cancer–are so tight and so consistent that there is a very high probability that the first is influencing the second.

You may have seen or heard reference to something called a “p-value” in a report about a clinical study. The p-value is how researchers estimate the likelihood of something being due to chance. If a p-value is less than 0.05, for example, that means the likelihood that the outcome is due to simple chance is less than 5%.

Medical Research Studies Usually Evaluate Relative Risk, Not Absolute Risk

As a simple example, many people believe that eating red meat is dangerous because they see headlines saying that a study showed meat eaters’ risk of developing cancer was, say, 45% higher than that of non-meat eaters. These headlines are actually describing relative risk, not absolute risk; and relative risk is meaningless if you don’t know the absolute risk. Say that one out of every 10,000 people who flies dies in a plane crash. If you fly once per year, we could say your absolute risk of dying in a plane crash is 0.01%. Now say that you fly twice a year. Your absolute risk is still only 0.02%. That’s so small that few people would worry about taking that second flight. Yet since .02 is twice as large as .01, we could write a headline saying that those who fly twice a year increase their risk by 100%. This would be scary unless you knew the absolute risk numbers.

Medical Research Studies Deal With Confounding Factors

One of the very reasons for a Phase 1 clinical trial, followed by a Phase 2 and so on is to try to minimize the confounding factors. As a clinical drug development or other medical study progresses, it will attempt to weed out as many confounding factors as possible by putting similar people into groups of similar sizes and adjusting data to compensate for the inevitable differences that confound the results. A confounding factor is any issue that might make it more difficult to work out exactly which is causing what.

In the meat example above, the death rates of those who eat the most meat are usually being compared with those who eat none at all–such as vegetarians. The problem is working out confounding factors. People who eat a lot of meat are usually not nearly so concerned with their health as vegetarians. This means they are also much more likely than vegetarians to smoke, drink heavily, ignore their doctor’s advice, and fail to exercise. They are also more likely to eat processed foods and larger amounts of sugar and refined grains. They also tend to be older and are more likely to have diabetes. It is very difficult, then, to work out whether–out of all those differences between these two groups–the one primary factor driving the increased rate of death for the first group is actually meat.

It is precisely because of these issues with probability, confounding factors, and the need to differentiate between absolute and relative risk that medical research studies are so vitally important. Without them, it would impossible really advance medicine, since every advancement would be a blind shot in the dark. With clinical trials, we can make much more informed and educated guesses that can lead to real breakthroughs.

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How Many Times Per Week Do You Take Pills Or Vitamins?

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How often do you think about the painkillers you take for a sore neck or the medication you rely on to soothe an asthmatic episode? We’ve all become accustomed to the benefits medical technology has on our everyday lives, to the point many forget the medical research studies that made it possible. Without a clinical study to properly test and evaluate the effects medication has on a varied and unique population there would be even more accidents and failures. Clinical drug development is the key to making sure we can all live a healthy and supportive life, no matter what.

What is the function of a clinical study? First and foremost it’s necessary to test a product in a safe and controlled environment to ensure it’s fit for its purpose. Each trial, also known as phase, needs to be followed closely. Medical standards change on a yearly basis and safety is always the most important factor to keep in mind for doctors, nurses and pharmacists. This is where terms like ‘informed consent’ come into play.

Informed consent is such an important aspect of the clinical study that the American Psychological Association’s Ethical Code recently gave it its very own section. For researchers that need to use children in a clinical study (as is defined by anyone under the age of 18), they are legally required to obtain the parent or guardian’s consent before proceeding. Failure to comply with these rules mean the clinical study will be unable to proceed.

The first trial, also known as Phase 1, requires that researchers test their experimental drug or treatment in a very small group of people. These are no smaller than 20 and no larger than 80, allowing the scientists to evaluate the safety and side-effects for the first time. Once the Phase 1 clinical trial has been completed they can move onto the second.

The second trial, also known as Phase 2 or Phase II, the drug or treatment will be given to a steadily larger group. These range from 100 to 300, depending, and the process is very much the same. According to a recent survey about clinical trials in the United States, over 90% of respondents said they have never participated in a clinical trial. Many researchers hope to spread awareness about the clinical study and the benefits it has on society on the whole.

The third trial is where the drug or treatment is administered to the largest groups of people, ranging from 1,000 to 3,000 and anywhere in-between. The studies have also expanded to explore not just side-effects, but compare it with equivalent treatments and how effective it is in the long-term. Once this is finished the last trial, or phase, can finally begin.

The last clinical trial sees the team submitting what’s known as a New Drug Application (or an NDA) for approval by the FDA. Of the nearly 10,000 drugs that enter every year, only 250 will make it to pre-clinical trial testing and only five to clinical trial testing. It’s estimated only one or two will actually reach FDA approval every year. Back in 1999 a clinical trial generally lasted 460 days. Compare this to 2005, where a clinical trial averaged nearly 800.

Without a careful and attentive clinical study many drugs and treatments would never make it to market to help people live their best life. The benefits of clinical drug development can be felt by adults and children alike. Will you offer your help this year?

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What You Need to Know About Clinical Drug Development

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Science, medicine, and technology have advanced considerable amounts over the recent years, and at the rate we are going, it seems that we could be on a pretty promising track for discovering all the cures we need, developing every device for communication and transportation that we could ever desire, and understanding the world around us and the universe like our species never has before. When you step back to look at the big picture of things, it really is quite amusing and intriguing that we are, by this point, basically catching up with some of the science fiction favorites.

We carry miniature computers in our pockets, constantly connected or at least in possession of the capability to access contact with anyone or any piece of information. We now live in a time in which personal drones are used to take vacation selfies and videos. There are devices that will not permit the ignition of a car?s engine if the driver is intoxicated. There seems to be no end to the impressive wonders that the brilliant human mind can develop. This applies to medicine as well. With numerous clinical drug development studies and trials every year, we just might be closer to all those cures than we think.

Medical research studies and clinical drug development

Yes, the progress in medical fields have been impressive, especially when you consider some of the treatments and remedies that were used in olden times, and were often the exact opposite of what you might have needed. However that does not mean that it is an easy process. The development and understanding of medicine is often a long, very complex road. A clinical study and trials are necessary to try out new medicines, and this process of clinical drug development can take quite a bit of time.

The phases of clinical drug development

There are four basic phases of a clinical trial. Phase 1 clinical trials are about testing the new treatment or experimental drug on a small group of individuals. This group usually ranges from 20 to 80 people. During this first test, experts examine the safety of the drug and attempt to pinpoint any side effects. Phase 2 takes the drug or treatment to a slightly larger group of people, often around 100 to 300 individuals.

The medical professionals continue to evaluate the safety and effectiveness of the treatment, as they do in Phase 3, when it is administered to around 1,000 to 3,000 people. At this point, experts can start to compare it with similar treatments or the standards that already exist. Phase 4 will include the trial team submitting a New Drug Application that will hopefully make it through to Research and Development, and eventually to approval by the FDA.

About 46% of people believe that participating in a clinical trial is just as valuable and important to health care and medical fields as donating blood is. If you can be a part of the crucial process of helping professionals understand and fine tune medicine and its effects, wouldn?t you want to make a difference?