Common Cancer Clinical Trial Questions | Lilly TrialGuide
Common questions about cancer clinical trials
How is participation in a clinical trial different than the standard care I would receive?
Cancer clinical trials generally add steps to standard care. For example, a cancer clinical trial will include:
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)
In addition, your care plan may be different than the standard care for your cancer type. To find out about any differences, ask the study team.
Why do cancer clinical trials include these additional requirements?
Clinical trials are needed to investigate if possible treatments are safe and effective. That's why new drugs are called 'investigational drugs.' Because less is known about investigational drugs, clinical trials require careful oversight of participants. Most of this oversight is provided by a team of doctors, nurses, and other research staff.
The study team's primary concern is your safety. So they monitor your health, look for side effects, and assess your response to the cancer treatment being studied. Researchers may need additional office visits, procedures, or assessments to monitor you.
But the research team does more than just monitor your safety. They may also assist with information or the logistics of taking part in the trial.
When should I consider a clinical trial and how will I know if 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, or other characteristics. Researchers develop these rules to minimize the risks to participants and prove whether the treatment works. You may not qualify for one study, but another study could be a fit.
The only way to know for sure if you are a good match for a clinical trial is to contact the study team. There are a couple of ways to find potential trial options. Some clinical trials post basic qualification details online, perhaps on a standalone website (like Lilly TrialGuide) or a study registry (like clinicaltrials.gov). Your doctor can also assist you in identifying options.
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.
Also, your study team will monitor you throughout the clinical trial to see if it's in your interest to continue. If they believe it's in your best interest to discontinue the study, they will suggest you do so.
Do I have to pay to participate in a cancer clinical trial?
Usually, all clinical trial drugs, 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. Routine costs relate to care you would receive regardless of whether you participate in a study. 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 study team.
What are placebos and how are they used in cancer clinical trials?
A placebo is a substance that looks like the investigational drug, 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 drug 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. This is only allowed when there is no known effective therapy.
What is randomization and how is it used?
Clinical trials group participants. These groups, or 'arms,' are used to compare new approaches to care with existing ones. Each group has its own dosing plan. The dosing plans may vary by type of medication used, strength of the medication, 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. Find out about a study's groups and your chances of getting each one by asking the study team.
To assign participants to a group by chance, researchers sometimes use 'randomization.' Randomization is usually done by a computer, similar to flipping a coin. This 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 study team will know which group you were assigned. However, your study team can find out your group assignment if it's needed for your care.
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 drug you're taking.
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 study drug.
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.
Consult with the study team to understand the purpose, benefits, and risks of biopsies and other procedures.
Why do people participate in cancer clinical trials?
Choosing to participate in a cancer clinical trial is an individual decision that depends on many circumstances.
People who participate in cancer clinical trials commonly cite these motivations:
Ability to try potential drugs and therapies ('investigational drugs')
Personalized cancer education
Updates about the study during and after participation
A feeling of control over treatment decisions
Advancement of medicine and helping others
It is important to know that some people choose not to participate for varying reasons.
The best way to know if you should participate in a clinical trial is to educate yourself as much as possible. Learn about how cancer clinical trials work. Assess different clinical trial options that may be available to you. Discuss each clinical trial option with the study team.
As you consider your options, clinical trial or otherwise, consult with your support network. Your family and friends, advocacy groups, your oncologist, and other patients all have a unique and important perspective to offer.
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