Medications are an important part of our medical world. They are needed to treat illnesses, prevent disease, and reduce pain levels. Many medications have been designed and improved upon and have been a crucial part in the complete eradication of many diseases. Although there is little question around the usefulness of pharmaceuticals, the drug evolution process is quite complex. It requires planning, testing, additional testing, and then a series of clinical trials. These clinical trials have the sole purpose of weeding out any harmful effects of the drug before they make it to the market. These clinical trials are used to measure a few important points.
A medication or pharmaceutical is usually not approved and sold on the market until it is considered safe. Although the majority of medications have some negative side effect, or some health problem possibility, the goal is that the benefits outweigh the negative possibilities. If a pharmaceutical is deemed to be useful, regardless of its side effects, then it is often put into the medical market.
A medication needs to work, and it needs to work every time. In some medical conditions, such as diabetes and high blood pressure conditions, the medication needs to be reliable. A clinical study may be completed to ensure that the drug effectively does what it says it is going to do. Many clinical drug development processes do not make it past this part, as they cannot prove their reliability.
To properly test reliability, phase 1 clinical trials tend to go for many months. In 1999, a clinical trial lasted 460 days, whereas in 2005, a clinical trial lasted 780 days. If the pharmaceutical successfully proves reliability during the long phase 1 clinical trial, it will go on to phase 2. Phase 2 often tests the effectiveness and safety to a large group of people, ensuring that it does not affect different people in drastically different ways.
Consistency is also important. If you only test a couple hundred people on a specific drug and the drug proves to be successful, these results are not inclusive enough. It is possible that a large percentage of the population will still experience harmful side effects. You cannot properly measure this without creating a sample of testers that are different and expansive.
In Phase 3 trials, the experimental drug or treatment is administered to large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely. Once this phase is completed successfully, the drug will go through a final phase, then pushing it onto the medical market for purchase.
In addition to the specific testing of the pharmaceuticals, the tests also need to be thoroughly investigated. The FDA does not want to put out a drug that happened to pass the tests, by chance. Although slim, this is a possibility. Medical research studies often have tests and measurement tools to specifically measure the accuracy of the tests that are used, such as the phase 1 clinical trial.
The P value, for example, helps to demonstrate the likelihood of study results being due to chance, rather than a difference between the treatments being tested. A P value of less than 0.05 is significant and shows that there was a less than 5% likelihood that the result happened by chance. The testing of accuracy also allows drugs to be compared against one another for effectiveness and safety.
Many people all over the world rely on the benefits of pharmaceuticals. Without clinical trials, such as phase 1 clinical trial and following phases, you would never know what is safe and unsafe on the market. The extensive process is done in an effort to only provide you with thoroughly tested medications. They medications are regularly tested for reliability, safety, effectiveness, and results by chance are weeded out.