![Lung cancer patient Ingrid Adams speaks with her nurse.](https://www.mskcc.org/sites/default/files/styles/large/public/node/122086/main_image/patient-photography-ingrid-a-231130-055-rt-edit_1200x800.jpg)
After participating in a clinical trial at MSK, Ingrid Adams had her lung cancer shrink substantially. Her disease has remained stable for more than six years.
Clinical trials, also known as research studies, test new treatments to see how well they work.
There are many common myths and misconceptions about clinical trials. It’s easy to be unsure about what’s true and what’s false.
MSK researchers run one of the world’s largest clinical cancer research programs. Our researchers test many types of treatments: chemotherapies, targeted therapies, immunotherapies, better ways of giving radiation therapy, and new methods for cancer surgery.
If you join an MSK clinical trial, you will be cared for by very experienced healthcare providers and researchers. They have special training in patient safety and care during a clinical trial.
Here are answers to some common questions people have about joining a clinical trial.
Can joining a clinical trial help me?
Yes.
- You may get early access to new treatments before they’re available at other hospitals.
- You’re making an important contribution to cancer research and helping other people with cancer.
Is being in a clinical trial risky or unsafe?
It is possible the treatment may not work. It may cause bad side effects. It is also possible the treatment may help other people, but not you.
Whatever the outcome, clinical trials are designed to keep you safe. Researchers must follow strict rules. Every clinical trial is approved and monitored by an Institutional Review Board (IRB) and government agencies. They make sure the trial is safe.
The IRB makes sure the risks are as low as possible and that there are more benefits than risks. Its job is to make sure each clinical trial is ethical and protects patients’ rights.
MSK scientists plan trials very carefully. They closely watch over people in the trial, and they follow rules to handle any problems. They can stop the trial if something does not seem right.
Researchers must follow a careful plan called a protocol. It describes exactly what will happen during the study. Before you join any clinical trial, you will get a copy of the protocol.
Why does MSK encourage people from all backgrounds to join a clinical trial?
MSK strongly encourages people from all races, genders, ages, and backgrounds to join clinical trials. It’s very important for research studies to include people from many backgrounds. That’s how our researchers can learn if a new treatment works for everyone, not just one group of people.
Here are some ways MSK welcomes everyone to enroll:
- We have a partnership with NYC Health + Hospitals to help their patients get access to clinical trials. We may offer the MSK-IMPACT® test to these patients, which tells us if they may be helped by an MSK clinical trial.
- We have expanded access to clinical trials at MSK regional locations. For example, many are available at MSK Nassau on Long Island.
Is the level of care the same in a clinical trial and regular treatment?
A clinical trial may take more time for treatment than normal care. There can be more visits, phone calls, treatments, a hospital stay, or a more complicated treatment.
For MSK patients in the New York City area, you may be able to have these appointments at our regional sites. You may also be able to conduct some appointments with your care team through telemedicine.
People in MSK clinical trials get a very high level of care. Many of our nurses have special training in clinical trials.
It’s possible a new treatment may cause side effects. But people in clinical trials are monitored very closely, even more than people getting standard treatment. Our clinical trial nurses are experts in helping manage side effects and symptoms.
What is informed consent?
Informed consent is how you learn about the details of the clinical trial. It’s written in simple wording, so it’s easier to understand. Researchers give you this information so you can make a choice about whether you want to enroll.
Researchers will explain:
- The trial’s purpose
- How long it will take
- What you will do
- Possible risks and benefits
- How they will protect the privacy of your health records
You can take the informed consent form home to read at any time, but you must sign the form before you join a clinical trial.
Informed consent lasts throughout the trial. The research team will talk with you about the trial and any side effects or other risks they found.
Are clinical trials only for people who have no other treatment options?
No. After you learn you have cancer, you can join a clinical trial at any time.
People once thought you could join cancer clinical trials only when you had run out of other treatment options. But today, many people choose to join a research study during their cancer treatment. That’s because we now have better ways of knowing if a promising new treatment matches a type of cancer. The latest molecular testing methods can tell us if the treatment we’re studying may be right for you.
Some clinical trials look at whether you can do well with less treatment, which could lower your chances of having long-term side effects from treatment.
Other clinical trials focus on screening and prevention in people who do not have cancer.
We encourage you to think about joining a clinical trial when your treatment starts. Talk with your doctor about whether there’s one that’s right for you.
What are the chances I will get a placebo?
A placebo (pluh-SEE-boh) is a pill or other substance that’s not a real treatment.
- Only a small number of cancer clinical trials use them.
- Early-stage trials do not have a placebo group.
- Researchers will tell you before you enroll if the trial is one that uses a placebo.
Trials that use placebos compare the standard treatment to a new treatment. They often give the standard of care plus placebo or a new agent. If only the placebo is offered, it is because all of the standard of care treatments are already given and no further treatment is known to be needed. If a placebo is to be used in a clinical trial, it will always be discussed with you first.
People who are in the control (placebo) group in trials may be able to get the new treatment later if it works best. Sometimes researchers stop a trial early if the new treatment works very well. Then everyone may be able to get the new treatment.
Do I need special connections to get into a clinical trial?
No. Anyone can enroll in a trial if they meet the conditions for joining, called eligibility criteria. Your doctor does not have to be involved in the research for you to join a clinical trial.
Eligibility is based on:
- The cancer’s stage and type
- What treatments you have already had
- Your general health
- Your age or gender
Following these eligibility rules keeps you safe and lets researchers learn the information they need.
Will I have to pay to join a cancer clinical trial?
In general, you do not pay extra out-of-pocket costs for treatments studied in a trial. Most often, the clinical trial’s sponsor pays for all research-related costs and any special testing. They may also pay for travel costs.
We will ask you or your health insurer to pay for anything that’s standard cancer treatment. Examples are routine tests, treatments, or procedures.
Before you join a clinical trial, we will give you an informed consent document. It tells you what you must pay for and what the clinical trial pays for.
MSK financial counselors can help you manage any insurance and financial questions about clinical trials.
What if I change my mind after I join?
You can leave a clinical trial at any time and for any reason. Joining a clinical trial is voluntary. The choice is yours. You can stop anytime if you feel uncomfortable or do not want to stay in the trial.
Can children join a clinical trial?
Yes. MSK Kids is where we treat children, teens, and young adults. Most of our young patients join some form of clinical research during their care. Over the years these trials have helped MSK greatly improve treatments for pediatric cancers.
Must I travel into Manhattan often?
Maybe not. We offer clinical trials at some of our regional locations, including:
- Long Island: Commack and Nassau
- New Jersey: Basking Ridge, Bergen, and Monmouth
- Westchester: West Harrison
MSK offers care related to clinical trials, including phase 1 trials, at our locations in New Jersey, Long Island, and Westchester County. MSK trials are also offered through our MSK Care Partners.
Your research team will talk with you about how often you may need to travel into Manhattan. You may not even need to come to the city.
For some clinical trials, you must stay in the hospital for a few days and receive most of your treatment in Manhattan. Examples are research studies for stem cell or bone marrow transplants or cell therapies like CAR T therapy.