If you are thinking about joining a clinical trial as a treatment option, the best place to start is to talk with your doctor or another member of your health care team. Often, your doctor may know about a clinical trial that could be a good option for you. He or she may also be able to search for a trial for you, provide information, and answer questions to help you decide about joining a clinical trial.

Some doctors may not be aware of clinical trials that could be appropriate for you. If so, you may want to get a second opinion about your treatment options, including taking part in a clinical trial.

If you decide to look for trials on your own, the steps discussed here can guide you in your search. The NCI's Cancer Information Service can also provide a tailored clinical trials search that you can discuss with your doctor. To reach them call 1-800-4-CANCER (1-800-422-6237) and select option 2. This is a free service. Keep in mind that the search results do not replace advice from your doctor.

Step 1: Gather details about your cancer

If you decide to look for a clinical trial, you will need to know certain details about your cancer diagnosis and compare these details with the eligibility criteria of any trial that interests you. Eligibility criteria are the requirements that must be met for you to join a clinical trial.

Examples of eligibility criteria include

• having a certain type or stage of cancer
• having received (or not having received) a certain type of treatment in the past
• having specific genetic changes in your tumor
• being in a certain age group
• medical history
• current health status

To help you gather details about your cancer, complete as much of the Cancer Details Checklist as possible. Refer to the form during your search for a clinical trial.

If you need help filling out the form, talk with your doctor or nurse or social worker at your doctor's office. The more information you can gather, the easier it will be to find a clinical trial to fit your situation.

Step 2: Find clinical trials

There are many lists of cancer clinical trials taking place in the United States. Some trials are funded by nonprofit organizations, including the U.S. government. Others are funded by for-profit groups, such as drug companies. Hospitals and academic medical centers also sponsor trials conducted by their own researchers. Because of the many types of sponsors, no single list contains every clinical trial.

Keep in mind that protocol summaries are written for health care providers and use medical language to describe the trial that may be difficult to understand. For help understanding the protocol summary, call, email, or chat with one of our cancer information specialists.

NCI-supported clinical trials

NCI's website helps you find NCI-supported clinical trials that are taking place across the United States, Canada, and internationally. The list includes

• All NCI network trials, including trials supported through the
  • National Clinical Trials Network (NCTN)
  • NCI Community Oncology Research Program (NCORP)
  • Experimental Therapeutics Clinical Trials Network (ETCTN)
• Trials that are funded in full or in part by NCI, including trials taking place at NCI-Designated Cancer Centers
• Trials at the NIH Clinical Center in Bethesda, Maryland

If you need help with your search, you can call, email, or chat with one of our trained information specialists. They will need to know details about your cancer, so have your Cancer Details Checklist ready.

Other lists of clinical trials

In addition to NCI's list of cancer clinical trials, you may want to check a few other lists.

ClinicalTrials.gov

ClinicalTrials.gov, which is part of the National Library of Medicine, lists clinical trials for cancer and many other diseases and conditions. It contains trials that are on NCI's list of cancer trials as well as trials sponsored by pharmaceutical or biotech companies that may not be on NCI's list.

Cancer centers and clinics that conduct cancer clinical trials

Many cancer centers across the United States, including NCI-Designated Cancer Centers, sponsor or take part in cancer clinical trials. The websites of these centers usually have a list of the clinical trials taking place at their institutions. Some of the trials included in these lists may not be on NCI's list.

Keep in mind that the amount of information about clinical trials on these websites can vary. You may have to contact a cancer center clinical trials office to get more information about the trials that interest you.

Drug and biotechnology companies

Many companies provide lists of the clinical trials that they sponsor on their websites. Sometimes, a company's website may refer you to the website of another organization that helps the company find patients for its trials. The other organization may be paid fees for this service.

Clinical trial listing services

Some organizations provide lists of clinical trials as a part of their business. These organizations generally do not sponsor or take part in clinical trials. Some of them may receive fees from drug or biotechnology companies for listing their trials or helping find patients for their trials.

Keep the following points in mind about clinical trial listing services

• The lists of trials provided by these organizations often draw from the trial lists that are available from the United States government (NCI and ClinicalTrials.gov).
• The websites of these organizations may not be updated regularly.
• The websites of these organizations may require you to register to search for clinical trials or to obtain trial contact information for trials that interest you.

Cancer advocacy groups

Cancer advocacy groups provide education, support, financial assistance, and advocacy to help patients and families who are dealing with cancer, its treatment, and survivorship. These organizations recognize that clinical trials are important to improving cancer care. They work to educate and empower people to find information and obtain access to appropriate treatment.

Advocacy groups work hard to know about the latest advances in cancer research. Some will have information about clinical trials that are enrolling patients.

To find trials, search the websites of advocacy groups for specific types of cancer. Many of these websites have lists of clinical trials or refer you to the websites of organizations that match patients to trials. Or, you can contact an advocacy group directly for help finding clinical trials.

Step 3: Take a closer look at the trials that interest you

Once you have completed the Cancer Details Checklist and found some trials that interest you

• Take a closer look at the protocol summary for each trial.
• Use the questions below to narrow your list to include only those trials for which you would like to get more information.

Key questions to ask about each trial:

Trial objective

What is the main purpose of the trial? Is it to cure your cancer? To slow its growth or spread? To lessen the severity of cancer symptoms or the side effects of treatment? To determine whether a new treatment is safe and well-tolerated? Read this information carefully to learn whether the trial's main objective matches your goals for treatment.

Eligibility criteria

Do the details of your cancer diagnosis and your current overall state of health match the trial's eligibility criteria? Some treatment trials will not accept people who have already been treated for their cancer. Other treatment trials are looking for people who have already been treated for their cancer.

Trial location

Is the location of the trial manageable for you? Some trials take place at more than one location. Look carefully at how often you will need to receive treatment during the course of the trial. Decide how far and how often you are willing to travel. You will also need to ask whether the sponsoring organization will pay for some or all of your travel costs.

Study length

How long will the trial run? Not all protocol summaries provide this information. If they do, consider the time involved and whether it will work for you and your family.

After thinking about these questions, if you are still interested in a clinical trial, then you are ready to contact the team running the trial.

Step 4: Contact the team running the trial

There are a few ways to reach the clinical trial team.

• Contact the trial team directly. The protocol summary should include the phone number of a person or an office that you can contact for more information. You do not need to talk to the lead researcher (called the "protocol chair" or "principal investigator") at this time, even if his or her name is given along with the telephone number. Instead, call the number and ask to speak with the "trial coordinator." This person can answer questions from patients and their doctors. It is also the trial coordinator’s job to decide whether you are likely to be eligible to join the trial. However, a final decision will probably not be made until you have met with a doctor who is part of the trial team.

  You will need to refer to the Cancer Details Checklist during this conversation, so keep it handy.

• Ask your doctor or another health care team member to contact the trial team for you. The clinical trial coordinator will ask questions about your cancer diagnosis and your current general health that you may not be sure how to answer. So, you may want to ask your doctor or someone else on your health care team to contact the trial coordinator for you.
• The trial team may contact you. If you have registered to use the website of a clinical trial listing service and found a trial that interests you, the clinical trial team may contact you directly by using the phone number and email address you provide when you register.

Step 5: Ask questions

Whether you or someone from your health care team speaks with the clinical trial team, this is the time to get answers to questions that will help you decide whether or not to take part in this particular clinical trial. Questions to Ask Your Doctor about Treatment Clinical Trials can help you think about questions you want to ask.

Remember to keep your Cancer Details Checklist handy to help you answer some of the questions that may be asked.

Talk with your doctor

To make a final decision, you will want to know the potential risks and benefits of all treatment options available to you. If you have any remaining questions or concerns, you should discuss them with your doctor. Ask your doctor some of the same questions that you asked the trial coordinator. You should also ask your doctor about the risks and benefits of standard treatment for your cancer. Then, you and your doctor can compare the risks and benefits of standard treatment with those of treatment in a clinical trial. You may decide that joining a trial is your best option, or you may decide not to join a trial. It's your choice.

Step 6: Make an appointment

If you decide to join a clinical trial for which you are eligible, schedule a visit with the team running the trial.

Clinical trials are research studies that involve people. Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with certain diseases.

What is the purpose of a clinical trial?

Clinical trials test new ways to find, prevent, and treat cancer. They also help doctors improve the quality of life for people with cancer by testing ways to manage the side effects of cancer and its treatment.

Why Are Clinical Trials Important?

Today, people are living longer lives from successful cancer treatments that are the results of past clinical trials. Through clinical trials, doctors determine whether new treatments are safe and effective and work better than current treatments. Clinical trials also help us find new ways to prevent and detect cancer. And they help us improve the quality of life for people during and after treatment. When you take part in a clinical trial, you add to our knowledge about cancer and help improve cancer care for future patients. Clinical trials are the key to making progress against cancer.

What are the types of clinical trials?

There are several types of cancer clinical trials. Each type of trial is designed to answer different research questions and will help researchers learn things that can help people in the future.

Treatment Trials

Most cancer clinical trials are treatment studies that involve people who have cancer. These trials test new treatments or new ways of using existing treatments, including new:

• drugs
• vaccines
• approaches to surgery or radiation therapy
• combinations of treatments

As researchers learn more about the genetic changes that lead to cancer, doctors are testing treatments that target these specific changes. So in some treatment trials, your tumor may be tested to see if treatments targeting specific genetic changes might work better than standard treatments.

Treatment trials are designed to answers questions such as:

• What is a safe dose of the treatment under study?
• How should the treatment be given?
• Does the treatment help people with cancer live longer than current treatment?
• Can the study treatment shrink tumors or slow their growth and spread?
• What are the treatment's side effects?
• Does the study treatment allow for a better quality of life with fewer side effects?
• Does the treatment help delay the return of the cancer?

Prevention Trials

Prevention trials are studies that look at ways to prevent cancer.

In most prevention trials, the people who take part do not have cancer but are at high risk for developing it. Or they have had cancer and are at high risk for developing a new cancer.

There are two kinds of prevention trials, action studies and agent studies. In action studies, you are asked to do something, such as exercise or follow a special diet. In agent studies, you are asked to take something, such as a drug or vitamin.

Researchers who conduct these studies want to know:

• How safe is the drug or activity?
• Does the new approach reduce the chance that someone will get cancer?

Screening Trials

The goal of cancer screening trials is to test ways to find cancer before it causes symptoms, when it may be easier to treat.

An effective screening test will reduce the number of people who die from the cancer that is being screened for.

But screening tests can have harms, which include bleeding or other physical damage. Other possible harms include a result that shows you might have cancer when you don’t. When this happens, it may lead to unnecessary tests and procedures. On the other hand, the results may show no signs of cancer when you have it. And sometimes screening can find cancers that would not have harmed you during your lifetime.

Researchers who conduct cancer screening studies want to know:

• Does finding disease earlier, before people have any symptoms, save lives?
• Is one screening test better than another?
• Do the benefits of the screening test outweigh the harms?

Supportive Care/Palliative Care Trials

These trials look at ways to improve the quality of life of people with cancer, especially those who have side effects from cancer and its treatment.

They might test drugs, such as those that help with depression or nausea. Or they might test activities, such as attending support groups, exercising, or talking with a counselor.

Some of these trials test ways to help families and caregivers cope with their own needs, as well as those of the person with cancer.

Researchers who conduct these studies want to know:

• How does cancer and its treatment affect patients and their loved ones?
• What can improve the comfort and quality of life of people who have cancer?

Clinical trials to test new cancer treatments involve a series of steps, called phases. Depending on the results of each phase, a treatment may move to testing in the next phase.

The Four Phases of Clinical Trials
Early clinical trial phases (phases 1 and 2) test for safety, such as what the side effects are and what a safe dose is. Later phases (phase 3 and 4) compare the treatment to current standard treatments.

In a phase 1 clinical trial, researchers figure out whether a new treatment is safe, what its side effects are, whether people can tolerate it, and the highest dose that people can tolerate. These trials are done in a small group of people (around 15 to 30). They also make sure a treatment affects the cancer.

A phase 2 clinical trial includes more people (50 to 100) to see if the new treatment seems to work against the cancer, such as by shrinking tumors or slowing their growth. Researchers want to see how the new treatment affects the body and fights cancer. In this phase, teams continue to study safety, including short-term side effects.

In a phase 3 clinical trial, researchers compare the treatment to the current standard therapy to see which works better. They also compare the side effects of the treatments. Participants are randomly assigned to one of the treatments to ensure that any differences are real and not the result of differences in the people in each group. Phase 3 trials include large numbers of people (from 100 to several thousand) to make sure that the result is valid.

Results from phase 1–3 trials are used to make decisions about approving new treatments or existing treatments for new conditions by agencies like the US Food and Drug Administration (FDA).

A phase 4 clinical trial looks at long-term safety and effectiveness that take place after a new treatment has been approved by the FDA and is available to the public. Treatment effectiveness and safety are monitored in large, diverse populations. More information is gathered as more people use the drug or device over a longer period of time.

Clinical trial randomization is the process of assigning people by chance to groups that receive different interventions or drugs in later phase trials. A computer is most often used to assign people to groups.

In the simplest trial design, the investigational group receives the study intervention or drug and the control group receives standard treatment.

At several points during and at the end of the clinical trial, researchers compare the groups to see which intervention or drug is more effective or has fewer side effects.

Randomization, in which people are assigned to groups by chance alone, helps prevent bias. Bias occurs when a trial's results are affected by human choices or other factors not related to the treatment being tested.

For example, if doctors could choose which patients to assign to which groups, some might assign healthier patients to the treatment group and sicker patients to the control group even without meaning to. This might make the treatment group appear better than the control group even if it isn’t. Randomization helps avoid biases of this type.

If you are thinking about joining a clinical trial that includes randomization, it is important to understand that neither you nor your doctor can choose which group you will be assigned to.

Placebos are rarely used in cancer treatment clinical trials. In most cases, a group of participants will receive the new treatment, and another group will receive the already approved standard treatment. Researchers will then compare the two treatments to see if the new treatment will become the new standard.

If placebos are used, you always will be told ahead of time and can ask questions before deciding to join the trial. The use of placebos in a clinical trial will be covered in the consent form.

When are placebos used in clinical trials? They are used when no standard treatment for a cancer exists. Or they may be used in a trial that compares standard treatment plus a placebo, with standard treatment plus the study treatment.

Placebos may be used in other types of trials, such as prevention trials.

Designing and running a clinical trial requires the skills of many experts. Different sites of the same trial may set up their teams differently. Typical team members and their duties include:

Each clinical trial that is funded by the federal government must be reviewed by scientists from relevant fields before people can enroll.

This expert review ensures that the trial is based on sound science. Though not required, many other clinical trial sponsors, such as drug companies, also seek expert advice on the scientific merit of their trials before opening them, although this is not required of trials that are not funded by the government.

If you take part in a clinical trial, your safety will be protected through the informed consent process, careful review and approval of the clinical trial protocol, and ongoing monitoring.

Informed Consent in Clinical Trials

Informed consent is an essential process through which the research team explains the trial to you before you decide whether to take part.

The research team explains the trial’s purpose, procedures, and possible risks and benefits. You have the right to ask questions and learn about all that is involved in the trial, including all your treatment options, details about treatment, tests, and possible risks and benefits.

They will also discuss other rights, including your rights to decide to take part in and to leave the study at any time. You have the right to both hear and read the information in language you can understand.

After discussing the study with you, the research team will give you an informed consent form to read. The form includes written details about the information that was discussed with you and describes the privacy of your medical records. If you agree to take part in the study, you sign the form.

But even after you sign the consent form, you can leave the study at any time. You can always ask questions. And as new information becomes available, the research team will inform you.

Children’s Assent

Children are not able to give informed consent until they turn 18.

So, before taking part in a clinical trial, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree. Unlike informed consent, assent is not always required by law, although institutional review boards (IRBs) may require it.

To take part in the assent process, your child must be mature enough to understand the trial and what they are required to do. Some children as young as 7 years old may be able to take part in the assent process. But this age varies depending on the child and the group running the trial.

As with the informed consent process, the assent process is meant to be an ongoing conversation between your child, your family, and the research team. This team may include doctors, nurses, social workers, and other health care providers.

During the assent process:

• The research team explains the trial to you. They will explain how the treatment in the trial differs from usual care. They will make sure you understand what will happen in the trial, and possible side effects, risks, and benefits.
• You give informed permission for your child to join the clinical trial.
• The research team explains the trial to your child in language they can understand, including what it means to take part and what they can expect.
• The research team may use written forms, videos, graphics, and other visual aids to help explain the trial to your child.
• Your child is encouraged to talk with your family and ask questions of the research team.

It may take several sessions before the research team feels that your child has a clear understanding of what the trial involves. At that point, your child is asked to show assent or dissent.

Both parents need to give permission. Usually, both parents will need to give permission for your child to take part in the trial, unless one parent

• has died
• is unknown
• is incompetent
• is not reasonably available
• has sole legal custody of the child

When Assent is not Required

Assent must be obtained from your child unless:

• your child is not capable of assenting
• your child might benefit from the treatment or procedure being studied in the trial
• the treatment or procedure that may benefit your child is only available in clinical trials

Even if assent is not required, your child will still benefit from going through the assent process. Doing so can help them feel more in control and engaged in the trial. It shows that they have a say in what happens to them and that their questions and input are valued.

Institutional Review Boards (IRBs)

IRBs review clinical trial protocols before clinical trials can accept patients. They check to see that the trial is well-designed, legal, and ethical; does not involve unneeded risks; and includes a safety plan for patients.

IRBs review clinical trial protocols yearly. They can change the protocol—or even stop the trial—if necessary to protect the safety of people enrolled.

Federal rules require that each IRB has at least five people, including:

• one scientist
• one person who is not a scientist
• one person who is not connected to, or not related to someone who is connected to, the site where the trial is taking place

Other members might include doctors, nurses, social workers, chaplains, patient advocates, and other health care or community professionals.

Data and Safety Monitoring Boards (DSMBs)

Some clinical trials—especially phase 3—use a data and safety monitoring board (DSMB). Like IRBs, these boards review the progress of a clinical trial and monitor the safety of those taking part in the trial. They also review data on the effectiveness of the trial interventions.

A DSMB is an independent group of doctors, statisticians, and others who are experts in clinical research and clinical trials. They ensure that trial data are complete. They can stop a trial early if safety concerns come up or if the main research question is answered earlier than expected. Stopping a trial early because the main research question has been answered may make it possible for people who are not in the trial to access an effective intervention sooner.

Office for Human Research Protections (OHRP)

OHRP protects people who take part in research and provides leadership for many federal agencies that carry out research involving people.

OHRP enforces important regulations for patient protection in clinical trials, called the Common Rule. These regulations set standards about:

• the informed consent process
• IRB formation and function
• the involvement of prisoners, children, and other vulnerable groups in research

Food and Drug Administration (FDA)

FDA protects people and ensures integrity of data from trials. They can remove researchers who do not follow safety rules. FDA approves new drugs before they can be sold to prevent fraud, ensure the drugs work as they should, and make sure drug’s health benefits outweigh their risks.

Ending Cancer Clinical Trials Early

Most clinical trials run as planned from beginning to end. But sometimes trials are stopped early. For example, the IRB or DSMB may stop a trial if the people taking part are having unexpected and severe side effects.

In some cases, a trial might be stopped because:

• There is clear evidence early on that a new treatment or intervention is effective. Then the trial may be stopped so that others can access the new treatment as soon as possible.
• There is clear evidence that the new treatment or intervention is not effective. In this case the trial may be stopped to spare the people on the trial from a treatment that is causing more harm than benefit.
• Enough people cannot be enrolled the results of other trials have been published that answer the research question or make it irrelevant.

You may be wondering if clinical trials cost money and who pays for them. You may also wonder if clinical trials are free.

Many clinical trial costs are covered by the sponsor of the study, a patient's insurance plan if one is available, and sometimes there are out-of-pocket costs. Before you join a study, ask the study coordinator which costs are covered and which are not.

Patient care costs in clinical trials

Patient care costs are those costs that you would pay even if you weren’t in a trial. These costs are often covered by health insurance.

Types of patient care costs may include:

• doctor visits
• hospital stays
• standard cancer treatments
• treatments to improve symptoms of cancer or side effects from treatment
• lab tests
• x-rays and other imaging tests

If you need to travel to take part in a study, other costs might include travel, lodging, meals, parking, or child and elder care. Sometimes trials can help cover these extra costs, so ask the research team if the study offers financial help or know of support organizations that offer help.

Research costs in clinical trials

Research costs are those costs that are related to taking part in the trial. Often these costs are not covered by health insurance. But they may be covered by the trial’s sponsor.

Examples of research costs include:

• the study drug
• lab tests performed purely for research purposes
• added x-rays and imaging tests performed solely for the trial
• extra doctor visits that you would not have with usual care

When you take part in a trial, you may have extra doctor visits that you would not have with usual care. During these visits, your doctor carefully watches for side effects and your safety in the study.

Before you join a trial, learn as much as you can about which costs you or your health plan need to pay and those that will be covered by the study. Talk with your doctor, the research team, and your health plan.

Ask your doctor if there is someone on staff who can help work with your health plan. This person might be a financial counselor or research coordinator. Or they might work in the hospital's patient finance department.

Ask the research coordinator or nurse if other people have had problems getting their health plans to cover routine patient care costs. If so, you might ask the research coordinator or nurse for help in sending information to your health plan that explains why this clinical trial might be a good fit for you. Items insurance companies may ask for include:

• medical journal articles that show possible patient benefits from the drug or procedure that is being tested
• a letter from your doctor that explains the trial or why it is a reasonable option for you
• support letters from patient advocacy groups

Call your health insurance plan. If your doctor does not have a staff person to help work with health plans, call the customer service number on the back of your insurance card. Here are important questions to ask:

• Does the health plan cover routine patient care costs for people taking part in clinical trials?
• If so, is a pre-authorization required? A pre-authorization means the health plan will review information about the clinical trial before deciding to cover the patient care costs.
• If your health plan requires a pre-authorization, what information do you need to provide? Examples might include copies of your medical records, a letter from your doctor, and a copy of the informed consent form for the trial. If a pre-authorization is not required, you don't have to do anything else. But it is a good idea to request a letter from your health plan that states that a pre-authorization is not needed for you to take part in the clinical trial.
• Understand all the costs related to the trial. Ask your doctor or the trial's contact person about the costs that must be covered by you or your health plan.
• Work closely with your employer's benefits manager. This person may be able to help you work with your health plan.
• Give your health plan a deadline. Ask your doctor or the trial’s contact person for a target date when you should start treatment. This can help to ensure that coverage decisions are made promptly.

What happens if my claim is denied?

If your claim is denied, contact your insurance plan's billing office for help. The billing manager may know how to appeal your health plan’s decision.

You can also read your health insurance policy to find out what steps you can follow to make an appeal. Ask your doctor to help you. It might help if they contact the medical director of your health plan.

Joining a clinical trial without insurance

If you don’t have insurance or have other financial worries that you think may prevent you from taking part in a clinical trial, there are places to go for help.

Some screening, prevention, and quality-of-life studies take place at sites that serve people with low incomes through the NCI Community Oncology Research Program (NCORP). If you receive health care at one of these sites, you may be able to take part in a clinical trial.

People with cancer may be able to enroll in National Clinical Trials Network (NCTN) clinical trials through NCORP, as well. Check with the clinic where you receive care about studies that you might be eligible for.

Federal health insurance and programs for clinical trials

Some federal health insurance programs help pay the costs of care in clinical trials.

Medicaid is a US federal health insurance program for people who cannot afford regular medical care. Medicaid covers all routine patient care costs in a clinical trial. Each state has its own rules about who is eligible for Medicaid. Visit Medicaid.gov to learn more about your state’s Medicaid program.

Medicare is a US federal health insurance program for people aged 65 years or older and people with certain disabilities. If you have Medicare, you may be reimbursed for some of the costs related to taking part in trials of new ways to diagnose or treat cancer. For more information, read the Centers for Medicare and Medicaid Services publication, Medicare and Clinical Research Studies or call Medicare at 1-800-MEDICARE (1-800-633-4227).

TRICARE is the Department of Defense’s health care program. If you are covered under TRICARE, you can be reimbursed for the medical costs related to taking part in NCI-sponsored trials for cancer prevention and treatment. Find more information on the TRICARE's website.

The Department of Veterans Affairs allows eligible veterans to take part in NCI-sponsored clinical trials at Veterans Affairs Medical Centers. All phases and types of NCI-sponsored trials are included.

When you need treatment for cancer, you may want to think about joining a clinical trial. By looking closely at all options, including clinical trials, you are taking an active role in a decision that affects your life.

This section has information on the risks and benefits of clinical trials to help you decide.

Possible risks in treatment clinical trials

Every clinical trial is different, which means risks can also differ. Some common risks include:

• The study treatment may not be better than, or even as good as, the standard treatment.
• Study treatments may have serious side effects that are worse than those of the standard treatment.
• You may be required to make more visits to the doctor and have more tests than if you were receiving standard treatment.
• You may have extra expenses related to these extra visits, such as travel, housing, and childcare costs.

Possible benefits of joining a clinical trial

Some of the benefits to joining a treatment clinical trial may include:

• The trial may help researchers learn more about cancer and help people in the future.
• You might have access to a treatment that is under study that may not be available to people outside the trial.
• The research team will watch you closely, adding an extra layer of care to your health.
• Though not common, if the treatment being studied is more effective than the standard treatment, you may be among the first to benefit.

Questions to ask before joining a clinical trial

If you are thinking about joining a clinical trial, here are some questions you may want to ask your doctor and the study research team.

Questions about the Trial

• What is the purpose of the trial?
• Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?
• How long will I be in the trial?
• How many visits will I need to make to the hospital or clinic?
• What kinds of tests and treatments are involved?
• How will the doctor know if the treatment is working?
• How will I be told about the trial’s results?
• How long do I have to make up my mind about joining this trial?
• Who can I speak with about questions I have during and after the trial?
• Who will be in charge of my care?

Questions about Risks and Benefits

• What are the possible side effects or risks of the new treatment?
• What are the possible benefits?
• How do the possible risks and benefits of this trial compare to those of the standard treatment?

Questions about Your Rights

• How will my health information be kept private?
• If I decide to leave the trial, what other options will I have?

Questions about Costs

• Which costs do I have to pay if I take part in the trial?
• What costs will my health insurance cover?
• Who can help answer questions from my insurance company?
• Who can I talk with about costs and payments?

Questions about Daily Life

• How could the trial affect my daily life?
• How often will I have to come to the hospital or clinic?
• Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
• How far will I need to travel to take part in the trial?
• Will I have check-ups after the trial?

Questions about Comparing Choices

• What are my other treatment choices, including standard treatments?
• How does the treatment I would receive in this trial compare with the other treatment choices?
• What will happen to my cancer if I decide not to have any treatment?

If you are thinking about taking part in a clinical trial, you should feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give you some ideas as you think about your own questions.

The study

• What is the purpose of the study?
• Why do researchers think the approach may be effective?
• Who will fund the study?
• Who has reviewed and approved the study?
• How are study results and safety of participants being monitored?
• How long will the study last?
• What will my responsibilities be if I take part?
• Who will tell me about the results of the study and how will I be informed?

Risks and possible benefits

• What are my possible short-term benefits?
• What are my possible long-term benefits?
• What are my short-term risks, and side effects?
• What are my long-term risks?
• What other options are available?
• How do the risks and possible benefits of this trial compare with those options?

Participation and care

• What kinds of therapies, procedures and/or tests will I have during the trial?
• Will they hurt, and if so, for how long?
• How do the tests in the study compare with those I would have outside of the trial?
• Will I be able to take my regular medications while taking part in the clinical trial?
• Where will I have my medical care?
• Who will be in charge of my care?

Personal issues

• How could being in this study affect my daily life?
• Can I talk to other people in the study?

Cost issues

• Will I have to pay for any part of the trial such as tests or the study drug?
• If so, what will the charges likely be?
• What is my health insurance likely to cover?
• Who can help answer any questions from my insurance company or health plan?
• Will there be any travel or child care costs that I need to consider while I am in the trial?

Tips for asking your doctor about trials

• Consider taking a family member or friend along for support and for help in asking questions or recording answers.
• Plan what to ask — but don't hesitate to ask any new questions.
• Write down questions in advance to remember them all.
• Write down the answers so that they’re available when needed.
• Ask about bringing a tape recorder to make a taped record of what's said (even if you write down answers).

This information courtesy of Cancer.gov.