What Are Clinical Trials and Why Are They Important?

What Are Clinical Trials and Why Are They Important?

What Are Clinical Trials and Why Are They Important? 

You may have heard of a clinical trial before, but you may be less clear about the actual role of clinical trials in health care and why clinical trials matter. If this statement rings true to you, you are not alone. Follow along to learn everything you need to know about the clinical research process and the importance of clinical trials. 

Clinical Trials Explained 

When was the last time you took a medication? For many people, taking medicine is a normal part of life—from prescription drugs that are taken daily to occasional doses of over-the-counter medicines, like cough drops or pain relievers. You may have wondered how these medicines ever came to be viewed as effective in humans. Or, you may have wondered how you can be sure that medicines are safe to take in a particular dose or at a particular frequency. For all of these answers, you can look to the power of clinical trials. 

Clinical Investigation Explained 

A clinical investigation, or clinical trial, is a highly structured research study. It occurs in a controlled environment, which allows very specific aspects to be compared with one another without being influenced by other factors (referred to as “variables”). Historians often refer to the first clinical trial as being conducted by physician James Lind in 1747, when he was studying the disease known as scurvy. Since that time, clinical trials have developed into a more uniform process to ensure that they are safe, ethical, and meaningful. 

Understanding Clinical Trials 

Clinical trials are often associated with drug development. However, they are also used to evaluate the effectiveness of new medical devices, treatment pathways, or surgery techniques. Ultimately, clinical trials provide a way for researchers to better prevent, identify, understand, and treat diseases. 

Participating in Research Studies 

There are a few primary goals of a clinical trial. The first goal is to examine whether a new intervention is safe. Then, researchers perform further investigations to determine whether a new intervention is effective. Clinical trial participants who participate in research studies may become involved in various phases of the research process. 

  • Phase I trial: Researchers test a drug or other intervention within a small group of people for the first time to determine that it is safe and to see if there are side effects. This may involve 20 to 80 people. 
  • Phase II trial: A larger group of people receive the intervention to see whether it is effective and to continue to monitor its safety. This may involve 100 to 300 people. 
  • Phase III trial: An even larger group of people (up to 3000) receive the intervention to evaluate its effectiveness, continue monitoring its safety, and compare it with other treatments or controls. The results of this type of trial can lead to the approval of a new treatment or intervention by the US Food and Drug Administration (FDA). 
  • Phase IV trial: The intervention continues to be studied within the general population, keeping an eye on new risks or benefits, as well as safety. 

The Clinical Trial Process 

Stage 1: Recruitment 

The first stage of a clinical trial is recruitment. Clinical trials depend on a pool of volunteers or participants, who must first be recruited. Researchers must make sure that clinical trial participants have certain characteristics or experiences so that they can be meaningfully compared to one another. The fewer differences between trial participants, the better researchers can tell whether a new intervention is working compared to a control. Effectively, researchers want to “compare apples with apples.” 

Stage 2: Randomization 

Once study participants have been selected, they are placed into different conditions, depending on the nature of the research. One group of volunteers may be randomly placed into a “control” group, which means that they will not receive the intervention being studied. Another group may be randomly placed into the investigation group, and they will receive the intervention being studied. 

Stage 3: Conducting the Trial 

Depending on the complexity of the trial, several different groups may be studied or compared at one time against the control. Importantly, the volunteers will typically not know which group they have been placed in (the intervention will be “blinded” or “masked.”). The participants will undergo whatever the intervention is (for example, taking a headache medication when they get a headache) and then record their results or submit data to researchers accordingly. 

Stage 4: Evaluating Results 

After the trial period has been completed, trial data will be synthesized and analyzed to determine whether the intervention has been effective. The particular design of the study influences how significantly researchers can interpret the results. For example, in the highest level of research, a randomized, double-blinded controlled trial, neither the participants nor the researchers know until after the study is over whether or not they received the intervention. This reduces the possibility of bias entering into the data. 

Clinical Trial Benefits 

There are numerous benefits to participating in clinical trials. First, if you or a family member has a rare disease, a clinical trial may be a way to access effective treatments earlier. If you’re a healthy volunteer participating in a clinical trial, you can benefit by knowing that you are contributing to the development of groundbreaking treatments and thereby helping your community. Clinical trial volunteers are also typically paid for their participation. 

“It is only through clinical trials that new medical breakthroughs can be developed, tested, and ultimately introduced to the general population.”

Clinical Trial Importance 

It’s hard to understate the significance of clinical research. It is only through clinical trials that new medical breakthroughs can be developed, tested, and ultimately introduced to the general population. Clinical trials provide a safe, highly regulated way to ensure that medical progress can be made in a way that simultaneously protects those involved in clinical research and also advances the care of all. 

Learning More About the Significance of Research Studies 

The teams at M3 Wake Research are committed to advancing medicine through clinical research trials to improve the lives of current and future generations. With nearly four decades of industry experience, M3 Wake Research excels at improving the health care of all through its clinical research impact. Interested in joining a study or want to learn more? View a list of our currently enrolling studies