It takes a long time to bring a drug or device to the market. The road is also not necessarily a straight one. If you have always wanted to learn something about the clinical drug development process, this is a good place to start. Medscapeandnbsp;took a good look at the process a few years ago and nothing has changed in the process.
To understand the clinical drug development process it is important to know how it is organized. It all starts with what is called the preclinical phase. This generally goes on for between three and four years. If it passes this step, it goes to the human clinical trials step. This is broken down into three phases. They get longer as the drug or device makes it through the steps. The three phases usually take one, two and then three years. If a medicine or device makes it through all of these, the company files a new drug application (NDA) with the Food and Drug Administration (FDA). Only when that agency approves it, can the marketing and sale of the product begin.
The Preclinical Phase:
This is an important part of the clinical drug development process. This is when researchers look at current research on a disease or condition. They then combine computer science, pharmacology and chemistry to develop a treatment. Better understanding of advancements in medicine and basic science can lead to the development of a new treatment. Once a treatment has been developed and the concept has been approved by the FDA, it moves to testing.
Before anything can be tested on humans, animal trials are conducted. Most of the time, researchers use rodents for this part of the process. Should these tests produce results that are consistent with what the researchers expected, a new NDA is filed with the FDA. Should that be approved, the drug or device can move on and be tested on human subjects.
Phase 1 Clinical Trials:
This is the first time the new device or drug will be used on people. For drugs, a group of healthy volunteers comes in and they are given a very low dose. This is a small group of people. There are times when people who have the problem that the drug is meant to treat are brought in. This is sometimes in cases when the illness is particularly dangerous. The group of people can range from 20 to 100. As the clinical study goes on, the dose of the drug that is being tested is usually increased incrementally. It is estimated that about two thirds of products that go through this process will pass and get to go on.
Phase 2 Clinical Trials:
Where are the first step in medical research studies are tested for efficacy in treating the disease or condition they were created to treat. To get that information, researchers try to use as few people as possible. They look at how many they need to make the determination of the treatment’s efficacy statistically. In most cases, the group of volunteers that is needed for this step of the clinical drug development process ranges from 100 to 300.
There are a few things that are looked at now. Researchers look for what the right dose will be, how it should be administered and how often it will be needed to be effective. The volunteers are closely monitored and undergo multiple assessments. This is the phase that weeds out a lot of treatments. There are a few reasons for this. The treatment may have serious side effects or simply, it may not work.
Phase 3 Clinical Trials:
This is the final hurdle a treatment has to clear before it can receive the blessings from the FDA and make it to the store. To make that happen, a much larger group is needed and more time is required. The group of volunteers increases to the thousands. It normally takes anywhere between two and ten years to finish. The scrutiny of the participants is intense. Only 10% of treatments that make it to this part of the clinical drug development process will fail to get to the store.
While the process to get to the store is long for medical treatments, it is well worth it.