What is a clinical trial?

A clinical trial is a research study done with real people — patients or healthy volunteers — to test whether a new medicine, treatment, or medical approach is safe and works the way researchers hope it will. Think of it as the final and most important step before a new treatment can be made available to everyone.

Before any new medicine reaches your doctor's office, it must go through careful testing in clinical trials to make sure it is both safe and effective.

Why are clinical trials important- why are they done?

Every medicine or treatment available today only became available because people volunteered to take part in clinical trials. Without clinical trials, there would be no new treatments for all diseases like cancer, heart disease, autoimmune conditions, or others.

Clinical trials help researchers:

• Understand if a new treatment works

• Identify possible side effects

• Compare new treatments to existing ones

• Improve quality of life for patients

When you participate in a clinical trial, you may help future patients — and possibly yourself.

Why do people take part in clinical studies?

People choose to take part in clinical studies for many different reasons, and there is no single "right" reason. Some of the most common motivations include:

• Taking an active role in their own healthcare — Some people want to go beyond standard treatment options and explore new approaches that may be better suited to their specific condition or situation

• Accessing study treatments not yet widely available — A clinical trial may offer access to an investigational medicine that cannot be obtained any other way

• Contributing to medical research — Many participants are motivated by the desire to help researchers better understand a disease, including why it affects people differently and how it might be treated more effectively in the future

• Helping future patients — Even if a participant does not personally benefit, their contribution may lead to new treatments that help others facing the same diagnosis

• Receiving closer medical attention — Participants in clinical trials are often monitored more frequently and thoroughly than in routine care, which some people find reassuring

• Supporting diversity in research — Some participants want to help ensure that new treatments are studied across diverse populations — including different ages, backgrounds, and ethnicities — so that findings apply to everyone

Whatever your reason for considering a clinical trial, it is a personal decision that should be made after careful conversation with your doctor and loved ones. There is no obligation to participate, and your standard medical care will never be affected by your choice.

Where do the ideas for clinical trials come from?

Clinical study ideas begin when doctors, researchers, patients, and caregivers/care partners identify important questions that still need answers—such as why a disease affects people differently, where current study treatments stop working or don't work well, or how care could be improved. Ideas may come from prior research study results, everyday experiences shared by patients and caregivers, or unmet medical needs. These questions help shape studies designed to better understand diseases and improve future care.

Who runs a clinical trial?

Every clinical trial has a sponsor — the company or organization that designs and pays for the research. This can include a pharmaceutical company, an academic institution, a doctor, or a health care provider. At Bristol Myers Squibb (BMS), we sponsor trials to develop new medicines for many different diseases and conditions.

The trial is led by a principal investigator, usually a doctor who oversees the research at a specific location (called a study site). A dedicated research team — including doctors, nurses, and coordinators — supports you throughout the trial.

What is an investigational medicine or treatment?

An "investigational" medicine is one that has not yet been approved by health authorities (like the U.S. Food and Drug Administration, or FDA) for general use. It is being studied to find out if it works and is safe for a specific disease or condition. Investigational medicines have already been tested in laboratories and animals before being studied in people. This is a requirement of the Food and Drug Administration (FDA). You may also hear the term study medication or study drug.

What are the different phases of a clinical trial?

Clinical trials are conducted in stages called phases. Each phase answers different questions:

Most trials you'll see listed on BMSClinicalTrials.com are Phase 1, 2, or 3. Although there are sometimes Phase 4 trials listed.

How is a clinical trial different from standard medical care?

With standard medical care, your doctor prescribes treatments that are already approved and widely available. In a clinical trial, you receive a treatment that is still being studied — which means it may or may not turn out to be better than what's currently available. The research team monitors you very carefully throughout the trial, often more closely than in routine care.

Who can join a clinical trial?

Every clinical trial has a specific list of requirements called eligibility criteria — the characteristics a person must have (or not have) to participate. These may include:

• Your age

• Your specific diagnosis or condition

• Your overall health status

• Previous treatments you've had

• Certain lab test results

• Whether you are pregnant or planning to become pregnant

These criteria exist to protect your safety and to make sure the results of the trial are meaningful.

Does it cost anything to participate in a clinical trial?

In most cases, the investigational medicine and study-related procedures (like lab tests and scans required for the trial) are provided to you at no cost. However, your regular medical care costs (like seeing your regular doctor for unrelated reasons) may still need to go through your health insurance and are not covered by the clinical trial.

Some trials offer reimbursement for travel, parking, or other expenses related to participation. You should ask the research coordinator at the study site about any costs before you join.

Will I be paid to participate?

Some clinical trials offer financial compensation for your time and inconvenience. This will vary based on the study and local regulations. You will be told about any compensation before you decide to join. If this is not shared with you, it is okay to ask about compensation.

Can children or teenagers participate in clinical trials?

Yes, some clinical trials are specifically designed for children or adolescents. Please see the informed consent section 3 for more details.

Can I participate if I am a caregiver, not a patient?

Most BMS clinical trials enroll patients with a specific medical condition or diagnosis. However, some research studies may enroll caregivers or healthy volunteers. Search BMSClinicalTrials.com to see what studies are currently available.

How are studies designed?

Clinical trials are carefully planned to answer specific medical questions as clearly and safely as possible. The way in which the study is performed is based on the phase of the trial, the population included and what the study is trying to learn. These are some terms you may hear or see when reading about a trial.

• Randomized vs non-randomized

• Blinded (single-blind, double-blind) vs open-label

• Placebo-controlled vs active-controlled (compared to standard treatment)

• Single-arm (everyone gets the same study treatment) vs multi-arm

• Observational Study – a type of research where doctors or researchers watch and collect information about those participating without changing their care or telling them what to do. Researchers simply observe what happens naturally over time and look for patterns. In these studies:
• Participants continue their usual medical care or daily activities

• Researchers do not give a new treatment, drug, or intervention

• No one is assigned to a specific group on purpose

What is randomization?

In some trials, participants are randomly assigned (like the flip of a coin) to receive either the study treatment or the standard treatment/placebo. This is called randomization, and it helps ensure that the results of the trial are fair and unbiased.

You will be told before you join a trial whether randomization is part of the study design and what your chances are of being in each group.

Non-randomized means everyone in the study will receive the same study treatment.

What does "blinded" or "double-blind" mean?

• Blinded: You or your doctor does not know which treatment group you are in during the trial.

• Double-blind: Neither you nor your doctor knows which group you are in. However, the sponsor of the study does and can tell the doctor if there is a safety concern.

This is done to prevent bias — so that expectations don't influence how results are measured. If there is an emergency or medical need, the research team can "unblind" your information to get you the right care.

What is a placebo, and will I receive one?

A placebo is an inactive substance — sometimes called a "sugar pill" — that looks like the real treatment but contains no active medicine. Placebos are used in some trials to compare how patients respond to the new treatment versus no treatment.

Important: In most BMS oncology (cancer) trials, you will not receive just a placebo alone. If a placebo is used, you are typically also receiving the best available standard treatment alongside it. You will always be told beforehand if a placebo is part of the study, and you can ask your research team to explain exactly what you might receive.

What is a "control group" or "arm" in a trial?

Many trials have more than one group of participants. These groups are called arms or cohorts. For example: 

• Treatment arm: Receives the new investigational medicine

• Control arm: Receives the current standard treatment or a placebo

This comparison helps researchers understand whether the new treatment is actually better, worse, or about the same as existing options.

How do I find a BMS clinical trial that might be right for me or my loved one?

You can search for BMS-sponsored clinical trials directly on BMSClinicalTrials.com. Here's how:

1. Visit BMSClinicalTrials.com

2. Enter your disease/diagnosis (e.g., "lung cancer," "multiple sclerosis") in the search bar

3. Filter by location to find trials near you

4. Review the trial details — each listing explains the purpose of the study, who can join, and where it is being conducted

5. Contact the research team  listed for the trial to ask questions or express interest

You can also search ClinicalTrials.gov, which is a public database of all registered clinical trials worldwide — not just BMS trials.

How do I know if I qualify for a specific trial?

Each trial listing includes some of the inclusion and exclusion criteria — the requirements to join. After reviewing these, you can complete a pre-screener on our website or on a website of a vendor with whom we collaborate. Or you can contact the research team at the trial site if their number is listed. They will often conduct a pre-screening conversation and may request some medical information (with your permission) to determine whether you might qualify. A study site will need your full medical records prior to participating in the trial.

Should I talk to my doctor before joining a clinical trial?

Yes, absolutely. Always speak with your doctor before making any decisions about joining a clinical trial. Your doctor knows your full medical history and can help you understand whether a specific trial is appropriate for you, what questions to ask, and how participation might interact with your current treatment plan.

You can also bring the trial information (from BMSClinicalTrials.com) to your appointment to discuss with your doctor.

What if there are no trials near me?

If you don't find a trial in your immediate area, consider these options:

• Expand your search radius on BMSClinicalTrials.com to nearby cities or regions

• Ask about remote or virtual options — some trials now allow certain visits to be done from home or at a local lab

• Check back regularly — new trial sites open frequently

• Talk to your doctor or a specialist at a major research center or academic hospital, as they may know of trials not yet widely listed

• Contact the BMS study team listed in the trial description to ask if new sites are opening

What is informed consent?

Informed consent is the process of learning everything you need to know about a clinical trial before you decide whether to join. You will receive a document — called the Informed Consent Form (ICF) — that explains:

• The purpose of the trial

• What you will be asked to do

• How long the trial lasts

• The potential benefits and risks

• Your rights as a participant

• What happens to your personal and medical information

You should take as much time as you need to read this document, ask questions, and talk it over with family or your personal doctor before signing.

Can children or teenagers participate in clinical trials and what is the informed consent process?

Yes, some clinical trials are specifically designed for children or adolescents.  If a child is enrolled, a parent or legal guardian must provide consent on their behalf. Older children and teenagers are usually also asked to give their own agreement (called assent) in age-appropriate language. The research team has a goal of making sure all of those participating in the research study understand the purpose, procedures, risks and benefits of the study before consenting to participation.

Is it required for the informed consent or assent to be signed prior to participation?

Yes — the Informed Consent Form/Assent must be signed before any trial-related procedures begin. However, signing is completely voluntary. No one can pressure you to participate. Choosing not to join a trial will never affect the quality of your standard medical care.

What if I don't understand something in the consent form?

Please ask! The research team — including the study doctor and research coordinator — is there to answer all your questions. You can ask for the information to be explained in simpler language, or bring a trusted friend, family member, or advocate with you to help you understand.

Can I change my mind after I have already signed the consent form?

Yes. You have the right to withdraw from a clinical trial at any time and for any reason, without penalty. Your decision will not affect your ongoing medical care. You will be asked to follow a safe "exit" process with the research team to ensure your health is protected as you leave the study.

What questions should I ask before joining a clinical trial? 

Here is a list of some questions to bring to your first conversation with the research team (you are welcome to ask additional questions not listed here):

✅ What is the purpose of this trial?  

✅ What are the possible risks and benefits for me specifically? 

✅ What study treatment will I receive, and is there a chance I'll get a placebo?  

✅ Has the study treatment been tested before?  

✅ How long will I be in the trial, and how often do I need to come in?  

✅ How many people will be in the study?

✅ Will my regular doctor be kept informed?  

✅ What costs will I have, and what is covered by the trial? 

✅ What happens to me if the trial ends early?  

✅ Can I keep taking the study treatment after the trial ends if it's helping me? 

✅ Who do I call if I have a problem or emergency?  

✅ How will I find out the results of the trial?

What should I expect once I am enrolled in a trial?

Once you join, you will typically:

1. Complete a screening visit — Tests and exams to confirm you are eligible

2. Begin the study treatment — You will receive the study medicine or procedure according to the trial schedule

3. Attend regular visits — You'll come to the study site (or connect virtually) for checkups, lab tests, and assessments

4. Report how you feel — You may be asked to fill out questionnaires about your health, symptoms, and quality of life

5. Follow trial guidelines — For example, avoiding certain foods, medications, or activities that could interfere with the study

The research team will give you a clear schedule of what is expected at the start.

How long does a clinical trial last?

The length of a clinical trial varies greatly depending on the disease being studied and the goals of the research. Some trials last only a few weeks; others may continue for several years. The Informed Consent Form will tell you the expected duration of your participation. You can ask the research team at any time how long you are expected to be involved.

How often will I need to come in for visits?

Visit frequency depends on the specific trial. During the early part of the trial, visits may be more frequent (sometimes weekly). As the trial progresses, visits may become less frequent. Some visits may be able to take place remotely — for example, via phone or video call, or at a lab near your home. Your trial schedule will be explained in detail before you begin.

Will my regular doctor be kept informed?

Yes, with your permission, the research team will keep your regular doctor informed about your participation in the trial. Good communication between the research team and your own doctor is important for your overall care.

What happens to my regular medications? Can I keep taking them?

This depends on the specific trial. Some trials allow you to continue your current medications, while others may require that you stop certain ones that could interfere with the study results. This will all be explained during the screening and consent process. Never stop taking any medication without first talking to your doctor or the research team.

Will I have to travel far for a clinical trial?

It depends on where study sites are located. Some trials have sites at major research hospitals or cancer centers that may require travel. Others have many sites spread across different regions to make participation more convenient.   Ask the research team what options are available.

What if I have a medical problem or emergency during the trial?

Your safety is the top priority. Every trial site has a 24-hour emergency contact number. If you experience a serious side effect or medical emergency, contact the research team immediately — and go to your nearest emergency room and tell them you are in a clinical trial.

Is it safe to participate in a clinical trial?

Every clinical trial is designed with patient safety as the highest priority. Before a trial begins, it must be reviewed and approved by:

• An Institutional Review Board (IRB) or Ethics Committee — an independent group that reviews the study to make sure it is ethical and protects participants' rights

• Regulatory authorities such as the FDA (in the U.S.) or equivalent agencies in other countries

What are the possible risks of participating?

Like any medical treatment, clinical trials carry some risk. Possible risks include:

• Side effects from the investigational medicine (some expected, some unexpected)

• The study treatment may not work for you

• Potential emotional stress from uncertainty

All known and possible risks will be clearly explained in your Informed Consent Form. You should always discuss the risks honestly with the research team and your personal doctor. There may be unknown risks. 

What are the potential benefits of participating?

Benefits may include:

• Access to the study treatment that is not yet available to the public

• Closer medical monitoring and attention from a specialized research team

• No cost for the investigational medicine and trial-related tests

• Contributing to research that may help future patients with your condition

• In some cases, a better health outcome than with standard treatment

However, benefits are not guaranteed. The research team will be honest with you about what to expect.

What happens if I am harmed as a result of participating in the trial?

If you experience a health problem that is directly caused by the trial treatment, you will receive medical care at no cost to you. The research team will provide treatment for any injuries or side effects related to the study. The Informed Consent Form will explain exactly what is covered. You can ask the research team to clarify this before you sign.

Will my personal and medical information be kept private?

Yes. Protecting your privacy is a legal and ethical requirement. Your personal information will be handled according to applicable privacy laws (such as HIPAA in the U.S.). However, any information shared for regulatory purposes is typically identified by a code number, not your name. Your identity will not be published in any research results.

Your data may be shared with:

• BMS (as the trial sponsor)

• Regulatory authorities (like the FDA), if required for drug review

• Independent safety monitors

What happens to my tissue samples, blood, or other biological samples?

Some trials collect biological samples (blood, tissue biopsies, etc.) for research purposes. The Informed Consent Form will tell you:

• What samples will be collected

• How they will be used

• Whether they will be stored for future research

• Whether you have the option to decline sample storage for future use

You will always be asked for your permission before any samples are collected or stored beyond the current study.

What happens when the clinical trial is over?

When a trial ends, you will have a final study visit or end-of-study assessment. The research team will:

• Check your health and any ongoing side effects

• Discuss what happens next for your medical care

• Connect you with your regular doctor for follow-up

• You will be told if there is a long-term follow-up study that you can participate in

The trial sponsor will analyze all the results and submit them to regulatory agencies if the treatment shows it works and is safe.

Will I be able to keep taking the treatment after the trial ends?

Sometimes. If the investigational treatment appears to be helping you, you may be eligible to continue receiving it through a compassionate use or expanded access program while waiting for regulatory approval. This depends on the specific trial and the sponsor's policies. Ask the research team about this option.

How will I find out about the results of the trial?

BMS is committed to transparency. Results from BMS-sponsored clinical trials are:

• Registered and reported on ClinicalTrials.gov

• Published in peer-reviewed medical journals

• Summarized in plain language so that participants and the public can understand the outcomes

You can also ask the research team to notify you when results become available, and you can find summaries on BMSClinicalTrials.com.

What if the trial is stopped early?

A trial may be stopped early for several reasons:

• The study treatment is working so well that it would be unethical to keep some patients on placebo or the old standard of care

• A serious safety issue is discovered that requires investigation

• The study treatment is not showing the expected benefit

In any case, you will be notified promptly, your care will be transitioned safely, and you will continue to receive appropriate medical attention.

What happens to my data after the trial ends? — Your de-identified data (it will not have your name, but a code number assigned to you during the study) will be stored on a computer or an electronic device.   

How long are my records kept? — Each study has a different requirement for how long the records are kept.  The study team can answer the specific time frame of the study you are discussing.

Can I be in more than one clinical trial at the same time?

Generally, no. Most clinical trials do not allow participants to be enrolled in other interventional studies at the same time, because taking two experimental treatments simultaneously can make it impossible to determine which treatment caused which effect — or could be dangerous. The research team will ask you about other trials you may be participating in during the screening process.

What is a "protocol"?

A protocol is the detailed written plan for the clinical trial. It describes the study's purpose, how it will be conducted, who can participate, what procedures will be done, and how data will be collected and analyzed. The protocol is reviewed and approved by ethics committees and regulatory authorities before the trial begins. You do not need to read the protocol, but you can ask for a summary at any time.

Who should I contact if I have questions about a specific BMS trial?

Each trial listing on BMSClinicalTrials.com includes contact information for the research team at participating sites. You can reach out to the site's research coordinator.  Don't hesitate to ask as many questions as you need.

Are there patient advocacy groups or support organizations that can help me understand clinical trials? 

Yes. Many disease-specific and non-specific advocacy organizations offer resources, navigation assistance, and support for patients considering clinical trials. Examples include:

• PAN Foundation - https://www.panfoundation.org/

• Long-Distance Ground Transportation - 1-800-296-1217 patienttravel.org

• National Volunteer Transportation Center – they promote and support the concept and practice of volunteer transportation, which includes volunteer driver programs, shared vehicle utilization, and ride-sharing initiatives. 1-212-247-8356 ctaa.org

• Cancer Support Community 

• Patient Advocate Foundation

• National Organization for Rare Disorders (NORD)

• American Cancer Society —  

For additional information, please visit BMSClinicalTrials.com or ClinicalTrials.gov. Always consult with your doctor before making any medical decisions. 

© Bristol Myers Squibb. This FAQ is for educational purposes only and is not a substitute for professional medical advice.