How Safety Is Monitored in Cancer Clinical Trials

If you or a loved one is undergoing cancer treatment, you may have heard about clinical trials.

Clinical trials are important medical studies that use people to test the effectiveness of new cancer procedures, medications, or treatments. They're vital to understanding how cancer forms and how best to treat it.

But before any protocol receives approval as a treatment option, it must first complete the phases of a clinical trial. During the clinical trial phases, participant safety is the research team’s top priority. Promising clinical trials become future methods for treating cancer on a global scale, so there are multiple layers of safety oversight.

Here’s what you need to know about patient protection and safety monitoring during cancer clinical trials.

How Do Cancer Clinical Trials Work?

Before it's tested on participants, a treatment begins as a concept in a laboratory.

Expert researchers test new ideas for cancer procedures, treatments, and prevention in the controlled lab setting. If a new idea begins to show promising results, it may start the journey toward becoming a clinical trial. The different purposes they create cancer trials for include:

• Diagnostic abilities.
• Prevention methods.
• Quality-of-life measures.
• Screening for potential cancers.
• Treatment methods.

The Phases of Clinical Trials

Clinical trials move through several phases. Each phase looks to answer specific questions while keeping participant safety a top priority. If you're considering joining a clinical trial, knowing its phase can help you understand what to expect.

Phase 0: Should this study progress?

In this phase, a very small group of people trial the medication or treatment. People involved at this level may be subject to extra blood samples, biopsies, or tests and scans. While it's very unlikely that anyone in the trial group will see benefits from this stage, there are fewer risks to weigh as well.

Phase I: Is this safe?

Safety is the top priority for phase I clinical trials. Researchers study adverse side effects and direct results as they seek to understand the highest dosage participants can receive.

Phase I looks at how the body responds to treatment — and how the treatment affects the body. The research team monitors each participant closely.

This phase may include up to 30 people. Typically, participants have different types of cancer, unless it's a highly specified trial.

Each person may receive a different dose of the medicine, as researchers determine the highest safe dose. It's important to note that phase I trials can be the riskiest because they involve different dosages. People with life-threatening illnesses often join phase I trials when other standard-of-care treatments have failed.

Phase II: Is it working?

If determined safe and effective enough during phase I, phase II opens the trial to a larger group — up to 100 people. Based on the phase I studies, each participant will receive the same dose of the medication.

Some cancer trials randomize groups and give them different doses or treatments to test safety and effectiveness. During this phase, less common side effects may emerge because the number of participants has grown significantly.

Phase III: Does it work better than the current standard protocol?

This phase compares the safety and effectiveness of the treatment under study with those of the current standard treatment. Phase III studies could include several hundred participants from all over the world.

Randomized participants receive either the new treatment or the standard treatment. Participants don't know which treatment they're receiving. Researchers record and compare the results.

It’s important to note that cancer clinical trials don't use “placebo” or sugar pills as treatment. All participants receive some form of active treatment — either the standard-of-care treatment or the study treatment.

Phase IV: What else is needed?

In the final phase of a clinical trial, the U.S. Food and Drug Administration (FDA) may approve the treatment method if it's proven effective.

Still, some questions may remain unanswered. During this time, thousands of people may be in the trial or using the medicine without being part of the study. The safety of participants is continually monitored, and researchers record long-term benefits and side effects.

Information about your experience on the medication helps researchers create the safest and most effective medications and treatments for cancer.

How Is Safety Monitored During Cancer Clinical Trials?

Safety is the top priority for researchers from the start of each clinical trial. The success of each trial depends on the quality of the data. Multiple research and data-monitoring safeguards are in place to protect study participants.

Eligibility requirements for cancer clinical trials

Not just anyone can sign up for and join a clinical trial. Researchers design each trial specifically for a type of cancer or treatment method. Participants in clinical trials must meet eligibility requirements, which might include but aren't limited to:

• Current medications.
• Health and medical history.
• Major organ function.
• Overall health and physical function.
• Specific type or stage of cancer.

These requirements ensure the safety and well-being of participants.

Informed consent for cancer clinical trials

Before joining a clinical trial, a participant must first give their informed consent. Informed consent is the written (or read) instructions for the trial and what you can expect from the research team, including:

• All procedures, medications, tests, or other measures asked of you.
• How researchers will protect your privacy and data.
• Other expectations for the clinical trial experience.
• Possible benefits.
• Possible risks.
• Purpose of the trial.
• Timeline for the trial and how long researchers will keep your data.
• Who's involved in the trial as part of your care team.
• Your rights as a voluntary participant in the trial, and how to withdraw from the study.

During this time, you can ask any questions you may have about the trial. The research team will then share an informed consent form with you to read and sign.

It's important to note that even after you sign the consent form, you may leave the trial at any time. The research team is there to provide answers and make you feel supported during the trial. Be sure to use them and speak up if you're ever feeling uncomfortable or would like to leave the trial for any reason.

Monitoring during cancer clinical trials

Clinical trial doctors and nurses are highly skilled researchers who thoroughly monitor their participants throughout the trials. Many participants see this close monitoring as another level of personalized cancer care.

The study team looks for adverse effects that could endanger your health and will reach out if they find any. Since you can end your involvement at any time, the research team ensures it's available and understanding.

Review boards

Another layer of safety during clinical trials is review boards. These include Institutional Review Boards (IRBs) and Data and Safety Monitoring Boards (DSMBs). Their most important function is to protect human participants in clinical trials.

Comprised of scientists and nonscientists, these boards review and approve all clinical trial protocols before the trial can accept participants. They review all the trial information to ensure it's ethical, thorough, and safe.

IRBs and DSMBs continue to review active studies annually. If at any time the board disagrees with the safety or regulatory aspects of a study, they may vote to stop the trial or change the protocol.

Should You Join a Cancer Clinical Trial?

Before joining a cancer clinical trial, consider these questions:

• Do I know all the information about this clinical trial and how it works?
• Have I thought of the benefits and risks?
• What are my goals with this clinical trial?
• Why do I want to be a part of this clinical trial?

If you’ve found a clinical trial you may qualify for, bring it to your cancer care team's attention. You'll want to include your care team and any friends and family in your support network before agreeing to the trial.

If your cancer care team is running the trial, ask them what questions you have. Make sure you have a clear picture of their expectations during the trial.

If you have any questions or concerns about your safety during a clinical trial, don't hesitate to reach out to your research team. They're there to provide you with answers and support while you undergo a new treatment that could become the next standard cancer protocol.