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Understanding Cancer Clinical Trials

People who participate in cancer clinical trials do so for a multitude of reasons. During clinical research, participants may have the chance to try drugs and therapies not otherwise available, thus helping in the development of new medicines and treatments for the future. Cancer clinical trials can also expand a person’s own knowledge of their disease and give them a feeling of control over their treatment options.

However, deciding whether or not to participate in research can be challenging. Every clinical trial is unique, and cancer clinical trials are different than trials for other conditions. It’s important to educate yourself on the process before deciding if participation is the right choice for you. Learn how the trial works by reaching out to the research team, talk to a doctor or other healthcare professional about your options, and lean on your support network—family, friends or an advocacy group—to offer a more personal perspective.

To get you started, we’ve provided insight into some of the more common questions about cancer clinical trials. The answers to these questions should be provided in the informed consent process for each trial but if not, be sure to ask.

Understanding Cancer Clinical Trials - GIF

How is participation in a clinical trial different than the standard care I would receive?

Generally, cancer clinical trials add steps to standard care. Here are a few examples:

  • An informed consent document and process to make sure you understand the study
  • Additional office visits, procedures, assessments or collection of data
  • Monitoring by people overseeing your care, including a research team, regulatory agencies, and ethics review boards (ERBs)

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Why do cancer clinical trials include these additional requirements?

Clinical trials are needed to investigate whether possible treatments are safe and effective. That’s why the unproven drugs in research are called “investigational medicines.” Less is known about investigational medicines, so clinical trials require careful oversight of participants, which may require additional office visits, procedures, or assessments. Most of this oversight is provided by a team of doctors, nurses, and other research staff.

The research team’s primary concern is your safety. They monitor your health, look for side effects, and assess your body’s response throughout the study.

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When should I consider a clinical trial and how will I know I qualify?

Clinical trials are available for all cancer types and stages. You can consider one at any time.

Each clinical trial has specific rules for who should participate, and the rules are different for each trial. These rules may require a particular type of cancer, a certain stage of disease, or other characteristics. Researchers develop these rules to minimize the risks to participants and prove whether the investigational medicine works. If you do not qualify for one study, another one could be a better fit.

The only way to know for sure if you are a good match for a clinical trial is to contact the research team and go through a screening process. Your doctor may help you find potential trial options, or you may search online. Consider a standalone website (like Lilly TrialGuide) or a trial registry (like to get the contact information for a research site near you.

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If I join a cancer clinical trial, can I discontinue participation?

Yes, you can leave a clinical trial at any time, for any reason. Taking part in a clinical trial is a voluntary decision. You have a right to change your mind about participating any time before, during or after the informed consent process. If you decide not to participate or to stop participating, your decision will not impact your ability to seek additional care.

Your research team will also monitor you throughout the clinical trial to see if it’s in your interest to continue participation. If they believe it’s in your best interest to discontinue the study, they will discuss that option with you.

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Do I have to pay to participate in a cancer clinical trial?

Usually, the investigational medicines, assessments, and tests will be provided at no cost to you.

However, care costs that are considered ‘routine’ may be billed to you or your insurance provider. These routine costs are related to care you would receive regardless of whether you are in a clinical trial. In some cases, your insurance provider may not pay for services ordinarily covered because they were performed in a research study. For general information about the difference between research and routine care costs, visit the National Cancer Institute’s Paying for Clinical Trials page.

Some cancer clinical trials also provide modest compensation or reimbursement for certain expenses. For example, if you are traveling to participate in a cancer clinical trial, you may be able to get reimbursed for travel expenses.

To be certain how payments and compensation are handled for a study, check with the research team.

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What are placebos and how are they used in cancer clinical trials?

A placebo is a substance that looks like the investigational medicine but contains no active ingredients.

Placebos are often used differently in cancer clinical trials than in trials for other conditions. Most often, when a placebo is used, it is given alongside a standard treatment and not given alone. In these instances, using a placebo allows researchers to compare the investigational medicine plus a standard treatment, versus the standard treatment only.

In some cases, a placebo is not used at all. Very rarely, placebo is used alone (see our separate analysis on this topic.)

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What is randomization and how is it used?

Clinical trials sort participants into groups. These groups, or ‘arms,’ are used to compare new care options with existing ones. Each group may vary by dosage of the investigational medicine or whether a placebo is included. By comparing how participants respond to the dosing plan in these groups, researchers can compare different approaches to care.

To assign participants to a group by chance, researchers sometimes use ‘randomization,” which is similar to flipping a coin. This random assignment method eliminates the possibility of researcher bias and ensures that every participant has the same chance of ending up in each group.

If your clinical trial is ‘double blind,’ neither you nor your research team will know your group assignment. However, your research team can find out if it’s needed for your care.

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Why are blood draws and biopsies often performed during cancer clinical trials?

Participants in cancer clinical trials often undergo extra tests like blood draws and biopsies. These extra tests help researchers in a variety of important ways. Most commonly, they show if a clinical trial is a fit for you, help monitor your health during the trial, and tell how you’re responding to the investigational medicine.

Tumor biopsies have an especially important role in clinical trials. A tumor biopsy is a procedure that removes a piece of tumor (a sample of cancerous cells) for analysis by a lab. Results of biopsies are called the cancer’s ‘histology.’ Biopsies can help diagnose cancer, learn the stage, track changes, and personalize treatments.

Biopsies are increasingly being used in cancer clinical trials for personalized care. Each person’s cancer has a unique combination of substances. Biopsies help researchers see the substances in your tumor. Researchers may use this information to study how it may affect prognosis or response to the investigational medicine.

Biopsies are also sometimes used for scientific purposes. In these instances, biopsies aren’t used to tell researchers about your specific situation, but rather are collected for general scientific advancement. If this is the case, researchers will obtain separate permission from you.

If you or somebody you know is interested in participating in a cancer clinical trial, we may have an option available. Visit our list of cancer clinical trials to learn more.

Tags: oncology,

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