We have come a long way in terms of pharmaceuticals and medications for the treatment of illness and chronic diseases. There are many medical disorders today that once had no treatment, or the ability to minimize the symptoms. As research and design continue to advance in medical research studies, we are likely to overcome even more diseases and disorders. The clinical study process helps further the research of pharmaceuticals in the following ways.
Allows researchers to learn more about a drug
Pharmaceutical researchers can only learn so much about a drug in the lab. They can learn about its ingredients and how it affects different parts of the body. However, without having the ability to apply it to a human with the intended symptom reduction, they can never fully understand its benefit. A clinic study gives researchers the opportunity to see how the drug works within the human body. It allows them to make needed improvements and to target it better to reduce specific symptoms.
Informs users of possible side effects
The majority of pharmaceuticals on the market have some risk of certain side effects. However, if the drug?s benefit outweighs the side effects, it is considered to be an effective drug. Without conducting a clinical study, researchers would never learn of these side effects until the drug was released to the general population. This could result in lawsuits and a lot of people suffering from serious side effects.
Clinic trials work on the idea of informed consent. Those patients who agree to test out the pharmaceuticals are also accepting the fact that side effects are possible. They are informed entirely about potential risks and benefits. Informed consent is so important today that in the 9th revision of the American Psychological Association?s Ethical Code, it has its own section, 8.02. The process of informed consent and clinical studies improves drugs for the general population.
Gives researchers the ability to test out minor changes
Sometimes, making minor changes to a drug?s ingredients can drastically change its process. These changes can result in helpful changes that better target the symptoms, or harmful changes that reduce the benefits of the drug. A clinical study consists of multiple phases. These different phases allow researchers to make needed changes and to track the differences. The first phase, also known as phase 1 clinical trial, also usually includes only a smaller population of people, so as to reduce the damages. By the third phase, it is expected that many of the problems have been worked out, and people are at less risk.
Phase IV, the final phase of the clinical drug development is to test for general population use. After completing Phase IV, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market. Of the 5,000 to 10,000 drugs that annually enter R and D, only 250 make it to pre clinical trial testing, only five make it to clinical trial testing, and only one makes it to FDA approval. The FDA is extremely strict in releasing pharmaceuticals, with the goal of protecting the general consumer.
The clinical study process is an extremely important method in finding new pharmaceuticals. The lengthy and complex process ensures that general consumers are protected and that the drugs they take are, in general, safe. Some 46% of people somewhat agree that taking part in clinical trials is as valuable to the health care system as giving blood. These clinical studies help to advance the research of drug medications and give consumers safe and reliable medications they can trust.