Understanding Clinical Trials

Before people can start using most medical equipment and drugs, these items have to go through a process. This process ensures that a specific item is safe to use by humans and can achieve the expected results. It takes researchers much effort, time, and money to approve a medicine. To make things easier and more effective, researchers carry out clinical studies that usually involve human participants. One of the most common clinical study types is clinical trials. People can voluntarily participate in such trials for many different reasons. In this article, you will learn how clinical trials go, why people choose to take part in them, and much more.

All You Need to Know About Clinical Trials

Clinical studies play a vital role in most of the medical progress we witness today. They are a highly reliable method for evaluating a new drug’s ability to help people in everyday life. Obviously, not just anyone can test a new treatment on human subjects. This process must take place under authorized supervision and with rigid terms.

Before testing anything on people, experts usually carry out laboratory experiments and studies on animals. If the new treatment passes these tests, researchers can take it to the next step of a clinical trial. However, it’s mandatory to get the Food and Drug Administration’s (FDA) approval before starting one of these trials.

What’s the Purpose of Conducting Clinical Trials?

The aim of this research is to learn more about a potential treatment’s effects in the real world. Clinical studies examine the benefits and drawbacks that participants encounter during the course of a study. This helps researchers in understanding how patients may be affected by new interventions, drugs, or treatments. Also, it allows health professionals to test the new medicines’ efficacy and safety by comparing them to current ones. Other purposes for conducting clinical trials may include:

  • Preventing health problems
  • Early detection of diseases
  • Enhancing the quality of life for people with chronic and deadly diseases
  • Learn about caregivers and other support systems

What Do Participants Go Through During a Clinical Trial?

Although there might be different reasons for conducting a clinical trial, the process is mostly the same. When a person decides to participate in a clinical trial, they will most likely go through four phases. These phases are as follows:

Phase I Trial

The first phase basically focuses on collecting additional information about an item’s possible risks and side effects. Usually, the average size of a group participating in this phase is between 20 and 80 individuals. If a treatment passes this phase, it will need to be tested on a larger number of people, which takes us to the second phase.

Phase II Trial

While phase I is concerned with safety, phase II is concerned with performance. The data from the first phase is typically used as a basis for the second. However, this one might take much longer to complete. That’s because researchers try to find out how effective a treatment is by testing it on a large group of people. The typical number of participants in this phase is something between 100 and 300 people.

Phase III Trial

On average, between a few hundred and about 3,000 individuals take part in a phase III trial. The reason why this phase requires so many participants is that it tests a wide range of doses and conditions (including control groups). The ultimate goal of a phase III trial is to collect as much data as possible on the safety and effectiveness of treatment. If the product under test passes all three stages, the FDA will green-light it.

Phase IV Trial

Once the FDA gives its approval, the phase IV trial will begin. This is the final stage of a clinical trial. It can help scientists get a better idea of a product’s overall reliability and effectiveness. In this phase, the participating group is usually larger than in all previous phases. That’s because the objective of this phase is to test the product on a large scale.

What Should I Do to Take Part in a Clinical Trial?

If you decide to participate in a clinical trial, you will find that there is a process you should go through before it accepts you. Different trials will have different conditions. The requirements for participating will generally depend on the trial’s specifics. So, you should expect to be rejected if you don’t meet those requirements. All things considered, a typical trial process looks something like the following:

  • Before starting, the researchers will need to know some information (mostly medical) about you. Also, you will need to know more details about the clinical trial you’re applying for. You can get this information from the professional team.
  • You’ll need to go through a screening procedure to see if you qualify for participation in the trial. You can’t be accepted unless this screening shows that you qualify.
  • If you are eligible and want to participate, you will have to sign a consent. This will confirm that you are aware of what you will be going through during this clinical study.
  • Once in, you will need to make an appointment for your baseline visit. That will be your first visit after which you will join one of two groups: either the treatment group or the control group.

Note: It’s important to stick to the trial’s protocols and get in touch with the researchers if you have any questions, feedback, or worries.

Reasons to Take Part in a Clinical Trial

People may choose to participate in clinical trials for a variety of reasons. However, if you want to know why you should do something, it’s not enough to look at why other people do it. You have to consider your own circumstances and do what fits your situation. Nevertheless, it might help you make a decision if you find out why others may take part in a clinical trial. Among the most common reasons:

  • The interest in helping shape the future of healthcare technology
  • Trying to improve a medical condition for which there is no cure or standard treatment option
  • Seeking alternative treatments if the conventional ones had not helped
  • The curiosity about state-of-the-art treatments before they hit the market

Bottom Line

Are you curious about new medical releases? Do you have a condition that’s hard to cure? No matter what reason you have, participating in a clinical trial might be a good option for you. You just need to be aware of the specifics of the trial you’re participating in. Clinical trials can be easily found on the internet or through registries and medical providers’ recommendations. If you decide to take part in a clinical trial, it’s important to commit to its guidelines. However, if you encounter any issues, you should contact the professional staff. They will help you out and provide you with the information you need.