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What Are Clinical Trials?

February 3, 2022

You’ve probably heard the term “clinical trial” before, but you may not know what it is or if it’s an option for you. Clinical research is a type of medical research aimed at helping people who have been diagnosed with incurable or complex diseases. Clinical trials in oncology are a specific form of clinical research with a primary goal of finding cures by discovering and testing new medical treatments. 

What Is a Clinical Trial?

A clinical trial is a type of study where people volunteer to test new treatments, devices, or drugs. These “tests” are often used to determine whether or not a new treatment is safe and effective for patients. Carefully administered clinical trials have provided medical treatments that worked for patients when nothing else would.

Clinical trials are critical to advancing many medical specialties, including developing new cures for life-threatening cancers. Additionally, newly developed treatments and medicines must go through a clinical trial to be approved by the FDA. With technological advancements and increased foundational knowledge in the medical research community, clinical trials are proving to be more productive than ever before–specifically concerning safety and effectiveness in treating various diseases. 

How Do Clinical Trials Work?

Clinical trials allow physicians to obtain a better understanding of treatment options. Staying at the forefront of this cancer research and innovation enables us to provide a genuinely patient-centric practice, offering the best treatment and disease education available. Clinical oncology research gives us options, giving our patients control during an intensely unpredictable period in their lives. 

Phases of Clinical Trials

Clinical trials are completed in various phases, often with early phase clinical trials progressing to later-stage trials for further testing and a better understanding of results and possibilities with specific treatment paths. Each phase is used to answer specific questions about the treatment or drug. Every phase of clinical trials poses various benefits and risks.

Phase 0

Phase 0 explores how a new drug might speed up and streamline the drug approval process. Researchers can evaluate whether the drug does what it’s intended to do by administering a few small doses to a few people. This phase typically has fewer than 15 people, saving researchers time and money on future phase trials. People in a Phase 0 clinical trial don’t benefit that much and aren’t at high risk due to the low drug doses.

Phase I

Phase I clinical trials typically include a small number of people with different types of cancer. This phase determines the highest dose of a new treatment that can be administered without causing severe side effects. First, a small portion of the group receives a low dose of the treatment drug, and researchers closely monitor if they experience any side effects. If side effects are minor, the next set of people receives a higher dose. They continue this clinical trial process flow until they find the correct dose with acceptable side effects. Researchers also evaluate what the drug does to the body and what the body does with the drug. 

Phase II

If a Phase I trial yields that a new treatment is safe, researchers conduct a Phase II trial to determine if it works for specific types of cancer. Then, doctors evaluate the benefits based on the treatment’s goals. For example, the benefits could be that the cancer shrinks or disappears or provides an improved quality of life. A clinical trial’s primary goal is to see whether people who receive the treatment live longer than those who don’t. 

A group of 25-100 patients with the same type of cancer get the treatment in a Phase II clinical trial with the safest and most effective dose found in the Phase I trial. Every patient typically receives the same dose, but sometimes different treatment groups test different doses and ways of administering the treatment to find the best balance of safety and response. Phase III clinical trials begin if enough patients benefit from the treatment with minimal side effects.

Phase III

Treatments that have proven successful in Phase I and II clinical trials must succeed in one more phase before being approved for general use. Phase III compares the new treatment’s safety and effectiveness against the standard treatment method. Phase III clinical trials include several hundred people that participate in a double-blind study. In this type of study, patients are randomly selected to receive the new or standard treatment. The doctor and patient don’t know which one they received in many cases. Like in previous phases, patients are closely monitored for side effects. 

Phase IV

Once the FDA approves new drugs, they monitor them for extended periods in Phase IV. Even after extensive clinical research, all treatment effects might not be known. Phase IV evaluates drugs that the FDA has already approved. Doctors can prescribe these drugs to patients, but more research might be needed to answer more complex questions. Phase IV involves thousands of patients and is the safest clinical phase because treatment has been extensively studied over time and given to many people. This phase also looks at how the treatment affects the quality of life and its cost-effectiveness.

The Basics of Clinical Trials in Oncology

If you’re considering participating in a clinical trial, it can be helpful to understand the prerequisites and what are the right questions to ask. For example:

  • What is the background of this clinical trial I am considering participating in?
  • What are the eligibility requirements?
  • Why is this particular clinical trial so important?
  • How is this trial expected to work?
  • How long will this clinical trial take?

Who Can Participate in a Clinical Trial?

Depending on the trial guidelines, there are clinical trials for almost anyone. However, specific steps have to be taken to join the trial. For instance, for children to join a study, their parents or legal guardians must grant permission. However, if the child is old enough, they have the option to decline — despite permission given by the parents.

In clinical trials for medication and treatments, each participant must meet specific criteria to be accepted into the program (often related to qualifiers such as age, general health history, gender, or stage of the disease). 

Why Are Clinical Trials Important to Oncology Research?

These studies give us insight into what does and doesn’t work in medical treatment. They also provide new, innovative treatment options for patients, providing plans for care that likely haven’t been available to them before. We can offer new treatments that safely and effectively help people through carefully run clinical trials.  

How Long Does Clinical Research Take?

Trials are a fraction of the clinical oncology research that creates a new drug or medical treatment. Before any patient is administered a new drug, it must first be made or discovered, purified, described, and tested in various labs.

There’s no set time when a drug or treatment is tested and approved. It can take up to 10 to 15 years. However, this period can vary. With improved research capabilities, we’ve seen more novel therapies approved in early-stage clinical trials over the past few years than ever before – all because they’re proving so efficacious in patient tests that their advantage is clear. 

About Horizon Oncology & Research Center

At Horizon Oncology & Research Center, the decision to enter a clinical trial is up to you. We have taken the necessary steps to offer access to world-class clinical trials to patients in our community. Contact us to learn more about our clinical trial opportunities and if they are right for you.