An Overview of the Clinical Trial Process

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Before pharmaceuticals release a new product in the market, clinical trials are usually conducted to test its effectivity. But what exactly happens during a clinical trial? Here is an overview.

What clinical trials are for

Clinical trials are conducted to test new and improved methods of treating, diagnosing, or preventing various health conditions. These trials are designed to gather information whether the treatment or device is safe and effective. Trials could also determine if there are side-effects, how much the product or treatment would cost, and how it compares to others in the industry.

The phases of clinical trials

Before moving on to clinical trials, treatments are usually researched in a laboratory first. Here, they might be carefully studied through different laboratory equipment and in laboratory animals. Once it is deemed highly likely to work, there would be a further evaluation in a small group of humans.

A clinical trial would then be conducted if the product is able to pass this evaluation. Clinical trials are conducted in different phases. Whether they should have certain pre-existing conditions or they should be healthy participants, clinical trials may have different requirements for volunteers depending on what is being tested. To describe how the usual processes for these phases, here is an example of a clinical trial for a new drug treatment.

In Phase 0, a small dose of the drug will be given to 10 to 15 people in order to learn how the drug is processed in their bodies and how it affects them.

person tapping on clinical trial concept on tablet

Upon moving on to Phase I, the aim would be to evaluate safety by finding the best dose with the fewest side effects among 15 to 30 patients. A few of them will be given very low doses and others will have higher doses, which will increase until the side effects become too severe or the desired effect manifests. If it is deemed safe enough, the trial proceeds to the next phase.

Phase II is designed to further assess safety and is done in a larger group which is closely monitored to see if the drug works. There could also be new combinations of drugs being tested. Once it is found to work, the next phase will be conducted.

There could be over 100 participants for Phase III trials who could be divided into two or more groups. This phase is mainly designed to compare the new drug to the standard-of-care drug in terms of side effects and to see which one works better. Each patient for this phase is watched closely, and the study will be cut short if the side effects of the new drug turn out to be too severe or if a group shows much better results than the rest. Typically, this phase is needed for FDA to approve the release of a new drug to the general public.

Phase IV tests new drugs approved by the FDA and could involve as much as hundreds of thousands of patients. This might allow for better understanding of the safety and possible short-lived and long-lasting side effects of the new drug. Since there are many participants, doctors can also observe how it may work with other treatments.

The diseases which easily led to death back then are now easily preventable. Understanding the process of clinical trials may help us appreciate the hard work experts have put into making these medical improvements happen.

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