Do You Take a Daily Medication That Was Once a Part of a Clinical Study?


Clinical study

The last asthma attack that you had was nearly 30 years ago. And although it has been nearly threee decades since you felt the tightening in your chest that led to you driving yourself to the emergency room, it is an experience that you will never forget.
The panic of not being able to breathe. The fear that you were getting worse and not better. The call into your building principal to say that there was no way you would be in to work in the morning.
Fortunately, however, this adult visit to the hospital was quite a bit different from the frequent asthma emergency room visits of your youth. The staff seemed very prepared; they were calm; they even gave you a prescription for a daily medication that they thought would be beneficial to you.
You have very scary memories of growing up with asthma. As a child with asthma in the 1980s, you had few choices. At the time there was no daily medication that could help regulate your symptoms. Instead, you often had to wait until it was a near emergency situation and let your parents know, even if it was the middle of the night, that you needed to get some help. The help that was available was likely the hospital emergency room where they would put you on oxygen and, if necessary, give you a steroid shot. They were long nights and you were usually exhausted in the morning.
In those years between the frightening childhood attacks and the last adult asthma attack, many medical advances were made. Through the use of medical research studies and even some clinical trials, asthma medications that are safe for both children and adults help asthma sufferers work to control their disease on a daily basis, instead of waiting for an emergency.
Medical Research Studies Help Doctors and Pharmaceutical Companies Provide Better Treatment
Although it is work that very few people are familiar with, medical research studies make use of very detailed plans for how new drugs and new procedures can be tested. Clinical drug development, for instance, requires drug companies to work through a series of protocols before a drug is ever allowed to come to market. Some of the processes are defined and explained below:

  • Phase I trials During this part of the development stage, researchers test an experimental drug or treatment in a small group of people. By small, the definition requires a group no smaller than 20, and no larger than 80. The obvious first purpose is to evaluate the safety and identify side effects of the treatment or the drug.
  • Phase II trials During this part of the developmental stage, researchers are using the experimental drug or treatment in a larger group of people. According to the regulations, this group can be no smaller than 100, and no larger than 300. The overall goal is to determine effectiveness and to further evaluate the safety of the drug or treatment.
  • Phase III trials involve researching the experimental drug or treatment to a significantly larger group. At this level, the drug or treatment is administered to a group of people not smaller than 1,000, but not larger than 3,000. This phase of the trial is to confirm the effectiveness, monitor side effects, compare standard or equivalent treatments, and and to collect information that will allow the experimental drug or treatment to be used safely.
  • Phase IV trials are even more extensive. The regulations are still very exact and researchers and developers work with guidelines that may be specifically catered to the particular treatment or drug. After completing Phase IV, the clinical trial team submits a New Drug Application (NDA). The NDA must be approved before the drug can go on the market.

Because of the need for all of these complicated and expensive steps, only 250 of the 5,000 to 10,000 drugs that annually enter research and development make it to pre-clinical trial testing. Of those 250, five make it to Phase 1 clinical trial testing. From there only one of these makes it to FDA approval. Medical research studies are extensive and the clinical study protocol is closely regulated and monitored for safety.

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