Role Of Clinical Trials In The FDA Drug Approval Process

Role Of Clinical Trials In The FDA Drug Approval Process

The Food and Drug Administration plays a vital role in the United States and all countries as well. It is the job of the FDA to protect the general health of individuals by regulating and testing consumable products. These regulations and research are done on food, tobacco products, dietary supplements, and, of course, prescription drugs. It is the FDA’s job to ensure that the products are safe through research and clinical trials.

As the United States, considers the possibility of expanding its presence to include a US Food and Drug Administration Israel as well, perhaps some of us would like to know more about the process in which the FDA goes about some of their research. For example, what exactly does it entail when a clinical trial is done for a drug approval process? Certainly something worth knowing about, so let’s take a closer look at this type of study by the FDA.

The Clinical Trials and Phases

The purpose of clinical trials is to gather information on the safety of a specific drug. This is done through four different phases using human volunteers who agree to take either the drug or a placebo to see what the reaction will be. Although this takes place in four phases, several steps will need to be conducted. The entire process can take years of research to come up with the final conclusion regarding the drug being tested.

Phase 1 of the Clinical Trial

During this phase, a group of up to 100 healthy volunteers are compensated for their time to try out the drug or medical device. This phase of the study is done to determine what type of effects both positive and negative individuals may experience. It is also done to figure out how the medication is absorbed and how long it takes for it to leave the body. This study can take months to complete.

Phase 2 of the Clinical Trial

This phase of the clinical trial can last up to two years in which to complete. During this phase, the FDA evaluates how efficient the medication of the device works for individuals. The study consists of a certain number of individuals receiving the experimental drug, while another group is given a standard placebo. The trial is done blindly with none of the volunteers knowing exactly what they received, and recording on whether they felt any effects.

Phase 3 of the Clinical Trial

This phase is similar to phase 2 except done on a much wider scale. This trial is conducted using up to thousands of patient volunteers willing to participate. Again the testing is done blindly using either test drug or a placebo. To conclude this part of the study, it can take several years to get the conclusive data needed.

Phase 4 of the Clinical Trial

This is the phase that takes place once the drug or medical device hits the market. During this time, the pharmaceutical companies could test the product against others already on the market. They could also study the effectiveness of the drug and whether any diverse effects are reported even at a low rate. Another thing that could be tested is whether the drug or device is cost-effective and whether insurance companies will cover it.

The whole process is quite time consuming, but is it perfect? Well, nothing is perfect. As we have seen through some issues that have been addressed about unforeseen dangers from drugs that have led to legal litigation, the process isn’t foolproof. The thing is, despite all the research and clinical trials no one can determine what the human body will ultimately do. The FDA does its best to make these drugs as safe as possible, but there is never any guarantee.

clinical research organization

Infographic provided by The Emmes Company, a clinical research organization.

Clare Louise