What Are Clinical Trials And How Do They Work?

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If you didn’t know the ins and outs of a clinical trial, COVID-19 kind of already gave us a crash course in how they work. The purpose of these studies is to test a hypothesis to gain medical knowledge. It is the foundation of science in healthcare and many other disciplines.

What Is a Clinical Trial?

There are two types of research formats:

  1. The Interventional study
  2. The Observational study

Interventional Study:
The interventional study relies on participants to test a particular treatment, medical device, or medication. It uses a control that either involves an accepted procedure or a placebo in the case of a drug.

It follows a predefined plan to provide accurate results and avoid what science calls confounders. These are outside factors that can influence the data but are not a part of the clinical trial itself.

For example, whether a person smoked or was overweight could skew the study results considering the effects of an energy drink on exercise.

Observational Study:
In observational studies, the researcher monitors the effects of some factors without intervening with the investigation.

For example, the team may pay attention to how often someone exercises versus where they live.

Clinical research happens in a variety of settings, from universities to hospitals. The duration also varies. While you may think of them as a means to test drugs or develop a vaccine, clinical trials also test other types of interventions, such as diagnostic methods, risk factors, and disease prevention.

Clinical Trial Phases

The participant’s experiences will vary, depending on what stage of the clinical trial they join. Clinical trials typically are divided into four phases:

Phase I
The first phase is the smallest, typically enrolling less than 100 individuals. Gauging safety is its primary purpose. It will also consider a dosage in the case of drugs or potential side effects.

Phase II
Phase II clinical trials proceed to the next level to determine the efficacy of the proposed intervention. They can run anywhere from several months to years, depending on what the study is testing. Their effectiveness relies on the individuals’ continued participation, making it a commitment for the long-term.

Phase III
Phase III clinical trials typically involve a few hundred to several thousand participants. Researchers work toward refining an intervention and begin testing in different groups. This stage will determine if it gets FDA approval to continue.

Phase IV
Phase IV clinical trials include larger numbers of participants from other groups. Often, unknown factors, such as how common a side effect is, come to light at this point as researchers gather more data.

The Gold Standard of Clinical Trials

Non-biased results are the pinnacle of clinical research. Scientists achieve this goal with what is considered the gold standard of these studies, the double-blinded trial. Neither the researchers nor the participants know what intervention each person receives.

For example, if you join a clinical trial to test a new medication, you won’t know if you’re getting the drug or a placebo. The investigators won’t, either. The reason is that a researcher could inadvertently let you know which medication you’re taking. That could affect how you report your experience and side effects.

Participant Compensation

Researchers understand the value of data. They also are fully aware of the gravity of what they are asking of you. Therefore, many investigators will often compensate you for your time and effort. Some may reimburse your expenses for participating in the study. It’s essential to find out ahead of time about the expectations.

Participant Protection

The research team screens potential participants before a clinical trial begins. They will explain its purpose, benefits, and potential risks to get your informed consent during this time. It’s critical to ask questions, such as:

  • How long will the study take?
  • Will you have to travel to a clinic or hospital?
  • What will my participation involve?
  • What follow-up will the investigators undertake?
  • How will you be compensated for your time?

If you sign an informed consent document, you are not obligated to participate through the duration. You can drop out if necessary. A code of ethics binds researchers to protect everyone in the clinical study. The FDA monitors all federally funded research to assure adherence.

Some trials may involve extensive tests or even hospitalization. Others may only ask you to fill out a daily or weekly online survey.

The researchers will protect your privacy. Usually, they use coded identifiers for participants instead of real names. While you should tell your doctor if you join a study, you can rest assured that your data are private. The investigator should clarify how any samples are handled after the trial.

Benefits of Participation

Many individuals chose to join to get access to an intervention they want or need. For example, a person with psoriasis may participate in a study if it hasn’t improved with their current treatment plan. If you have a condition for which there is no treatment, participation may provide some much-needed answers.

Others might feel a moral obligation to help other people to improve their quality of life with new interventions. Your involvement may lead to breakthrough treatments. Many people find the possibility one of the most rewarding aspects of it. Examples of some recent breakthrough clinical trials include the University of Nottingham in England discovery of early detection blood test for breast cancer.

Your next question may be how to join a clinical trial.

Requirements and Screening

Researchers develop protocols for their studies that often involve specific population groups or particular health conditions. That’s one reason why they conduct extensive screening to select appropriate participants.

It’s imperative to understand that all trials have risks. After all, that’s the purpose of conducting them in the first place. We suggest asking about what pain or discomfort you may expect. Find out what happens in the case of side effects or injuries.

Final Thoughts

Clinical studies have revolutionized health care since the first controlled trial occurred in 1747. We have treatments for diseases and means to prevent their spread that we may never have had if it weren’t for the researchers and the brave participants. It begins with a question, but it relies on the data that you can provide.

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