Clinical trials are research studies that include human participants. Clinical trials can investigate how an experimental drug might act in the body and affect a disease.

You may also see a clinical trial referred to as a “clinical study” These terms mean the same thing.

People take part in clinical trials for a variety of reasons that are unique to them. Some people may decide to take part for reasons such as:

• to help researchers better understand a disease
• to help researchers find potential new treatments for future patients
• to get access to experimental medications

People of many ages and backgrounds participate. However, there are eligibility requirements for each research study that must be met in order to take part.

Requirements may be based on:

• age
• gender
• type/stage of disease
• previous or current treatments
• other medical conditions

Share the eligibility requirements for the study you are considering with your doctor and discuss whether you might be eligible. Your eligibility to participate will ultimately be determined by the study doctor.

The ICF is a document that is made to help you understand a specific clinical trial. This document guides you through what you can expect in the clinical trial before you make your decision of whether to take part in it.

You can take as long as you need to read the ICF and make your decision. If you decide to take part in the clinical trial, you will then be asked to sign the ICF to provide your informed consent. The participant may withdraw from the trial at any time.

Keep in mind that each person’s experience is unique. Some people may experience risks, while others may not. Examples of some of the risks you may face are:

• Study drug risks, called side effects, may be caused by the study drug(s) themselves
• Study procedure risks may be caused by doing procedures like x-rays, by dyes in CT scans, or by needle punctures from blood collection
• Unknown risks are also possible because the study drug(s) are still being researched. These may include, but are not limited to, risks to reproduction, and risks related to taking other drugs at the same time.

There may not be any benefit to you from taking part in a clinical trial, as researchers are still trying to figure out if the trial drug(s) will have any positive effect on you or your condition.

Researchers hope that the information they collect from a clinical trial will help them understand the experimental drug(s) better. To help researchers find potential new treatments for future patients.

Research is strictly regulated and adheres to strict ethical standards. Laws and regulations have been put in place to protect participants in research. Study doctors, the hospital/clinic performing the research and the research sponsor all must adhere to Federal, Provincial, and local requirements regarding the protection of human subjects.

Before a study begins, the research plan is reviewed for approval by an ethics committee. An ethics committee is a group of doctors, researchers, community-members, and others who are independent from the group running the study. Their job is to protect the rights and welfare of participants in clinical trials.

Clinical studies are typically classified into four phases:

• Phase I: Researchers test an experimental drug for the first time in humans by giving it to a small number (20-80) of healthy volunteers/patients to evaluate how the drug works in humans and identify side effects.
• Phase II: The experimental drug is given to a larger number of people (100-300) who have a particular disease or condition to further evaluate the side effects and whether the drug works as treatment for a specific disease.
• Phase III: Several hundred to several thousand people with the disease or condition participate in these studies. The experimental study drug undergoes additional testing to further evaluate the side effects, how well the drug works, how much of the drug people should take and how the drug compares to current standard treatments.
• Phase IV: Clinical trials in this phase are conducted after the drug is approved and available by prescription. Researchers are looking to understand the best way to use this drug as a treatment and whether there are any other risks or benefits for using this drug.
  

All potential clinical trial participants must go through a screening process. The screening process helps the trial physician to ensure that the individual meets the eligibility requirements to participate in the trial. The screening process is designed specifically for each trial but will generally include the following steps:

Pre-screening Assessment – the initial screening may take place via a phone call. During the phone assessment, you will be asked general information such as your age, race, your preferred method of being contacted and to verify your contact information. You will also be asked about your general health and any medications you may be taking. The trial physician may determine whether adjustments need to be made to your current medication dosing.

Screening Appointment – if you are still eligible to participate in the trial after completing the pre-screening assessment, you will be given an appointment to come to in for an in-person evaluation. During this visit, the study team will explain the trial and ask you to review and sign the informed consent form. The study team will also explain all of the inclusion and exclusion criteria, ask about your medical history and review current medications, and perform a physical examination. The physical exam may include height, weight, temperature, blood pressure, and blood and urine tests. Based on your medical history, you may have additional testing. The screening period usually takes two visits to complete.

Many clinical studies are designed to prevent anyone (including doctors, nurses, or participants) from affecting the trial’s scientifically accurate results. Blinding (or masking) is a process used to prevent participants and/or investigators from knowing which treatment group each participant is in. 

In a single-blind trial, participants don’t know whether they’re receiving the experimental drug or something else, but trial investigators do. In a double-blind trial, neither the participants nor the investigators know who is receiving the trial drug.

Some studies have a control group. This is the group of participants in a clinical research trial who receive either a standard treatment for their condition or a placebo. This group is compared to participants in another group who are given the trial drug or treatment. In some studies, the control group is compared to more than one treatment group.

You should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial and what the patient’s commitment will be like.

The following questions are some examples of what might be helpful to discuss with the study team. Some of the answers to these questions would typically be found in the informed consent form.

About the trial

• What is the purpose of the trial?
• What kind of patients are taking part in the trial?
  
• Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  
• What kinds of tests and experimental treatments are involved?
  
• How do the possible risks, side effects, and benefits in the trial compare with my current treatment?
  
• How might this trial affect my daily life?
  
• How long will the trial last?
  
• Will hospitalization be required?
  
• Other than this clinical trial, what are my options?
  
• Who will be in charge of my care?
  
• Is it possible that I won’t be eligible for the trial?
  
• How will this trial benefit me?
  
• What happens if my disease gets worse while I am in the trial?

   

About study treatment and study appointments

• Who will pay for the experimental treatment?
  
• Will I be reimbursed for other expenses?
  
• How will I know that the experimental treatment is working?
  
• Have other people with my condition received this experimental drug already?
  
• Will I get to choose which drug I receive?
  
• Is there a chance that I might get a placebo or the standard of care?
  
• What happens if I miss an appointment?
  
• How do I prepare for each visit?
  
• Where do I need to go for each procedure?
  
• Is there support available if I can’t get to a certain location?

   

About side effects

• What kind of side effects might I experience?
  
• What can I do to manage my side effects?
  
• What are my options if I can’t manage my side effects?

   

After the trial is completed

• What type of long-term follow up care is part of this trial?
  
• Will results of the study be provided to me?
  

Here are some suggestions 

• Plan ahead and write down possible questions to ask.
• Ask a friend or relative to come along for support and to hear the responses to the questions.
• Ask the team about any medical terms or concepts that you don’t know or are confusing to you.
  

To help you get started, here’s a list of factors that you may want to think about as you learn more about a specific clinical trial:

• Will I have a convenient way of getting to the clinic?
• Do I have support or a caregiver to help me through this?
• If I choose to take part in this clinical trial, will that affect my chances of taking part in other clinical trials later on?
• Will I be able to choose which drug I receive?
• Will I have to take time off work?
• Will I still be able to take part in the activities that are important to me?
• If I move, can I continue the trial at another hospital?
• Will I be allowed to get pregnant while participating in the trial?
  

Enrolling in a clinical trial is a decision that a patient usually makes in consultation with the doctor and their loved ones. Study Connect offers tools to help inform those decisions.

Many Bristol Myers Squibb trials presented on Study Connect include easy-to-use screeners. Patients can answer a few simple questions to see if they might qualify for a study. Also, you could print out the formatted study detail page to help you have an informed conversation with your doctor. 

The best patient is an informed patient and clinicaltrials.gov lists clinical trials available from all research sponsors. Review clinical trials you are interested in carefully.

Depending upon certain criteria, some people may be eligible to participate in an Early Patient Access (EPA) Program (also known as Compassionate Use). We welcome requests for early patient access from the physicians treating these patients.

Physicians can submit an early patient access request on behalf of their patients.

Study drug, study visits, and any medical tests specifically needed for the study  are provided without cost to participants. 

Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know. Clinical trials are completely voluntary and participants can leave the trial at any time for any reason. There is no penalty or fee of any kind for withdrawing.

Randomization occurs when a participant is selected by chance (not by choice) to join a trial treatment group. This is similar to being chosen by flipping a coin. For example, if an experimental medication is being compared to a currently available drug or placebo (an inactive drug), there may be 2 trial groups. One group of participants may receive the experimental medication, while the other would receive a placebo. The study doctor has no say on which treatment group patients are placed in.

The standard drug or the placebo may be made to look the same as the experimental medicine so that trial participants are unable to tell the difference between the drugs.

This will vary depending on the trial and the experimental drug being administered. The Informed consent form (ICF) will detail any known side-effects that might be expected. The study team can also answer any questions.

During a trial, patients are encouraged to report any “Adverse Events.” This refers to any side effects or distressing medical events they may experience. These are logged and investigated as part of the trial data collection and help to determine the overall safety of the experimental medication.

When you finish a clinical trial, you may have many questions. Your clinical research coordinator is in the best position to help you plan what to do next.

Regardless of next steps, make sure to request a copy of your medical information collected during your participation in the trial. That will be important for doctors you may see in the future.

If, after taking one of our preliminary screeners you do not seem to qualify for any studies, you have the option to see studies from other sponsors that are running trials related to your condition from data provided by clinicialtrials.gov.

Care for kids. Help your loved one enjoy some downtime by entertaining the kids. If your loved one prefers not to be left alone, offer to come over and entertain the kids at home. Recognize that young children may feel worried or confused about why their parent is ill and needs help. Be prepared for such a discussion by being honest while supportive and dispel any worries that children may have about causing their parent to become ill. For school age children, it’s important for their teachers to be aware of the situation.

Care for pets. Take the dog for a walk or to the dog park. Pet treats and toys are always a nice surprise. Consider boarding a pet if the owner will be away from home for an extended time.

Care for teens. Teens may have unique concerns and needs if a parent has cancer. Commonly when a parent is ill, teenagers are forced to assume a lot of adult responsibilities — cooking, cleaning, babysitting more, giving up time with their friends. Make sure that teens still get to be teens, and that when they help out, they are recognized for pitching in. Give them an opportunity to communicate with you so they can tell you their concerns and feelings.
 

Reprinted with permission from Patient Resource LLC.

Cook. Consider your loved one’s special diet needs and preferences when preparing meals. Friends often want to help, so accept their offers to bring over meals. Be sure to give them detailed information about the types of meals to prepare to make sure they adhere to the nutrition guidelines your loved one must follow.  

Perform outdoor chores. Mow the lawn, trim the hedges or shovel snow while your loved one is going through treatment, or find a service that will handle these chores.

Shop. This activity can be stressful and overwhelming for your loved one who may not be feeling well. Volunteer to shop or order online to save valuable time and energy for both of you.

Clean. Coordinate housework to happen while you are at doctors’ visits, or set aside a block of time to help do the house chores. A prime time for cleaning is during chemotherapy, if that is part of the treatment plan. And, if someone wants to buy a gift for the patient, suggest a visit from a housecleaning service.

Promote safety. Reduce clutter in the home, use night lights and put a sticker on the phone with an emergency number to call. Consider medical identification jewelry.

Reprinted with permission from Patient Resource LLC.

• Support. Help find a cancer support group.
• Exercise. Your loved one may feel too tired to exercise after treatments, but rehabilitation is important. Suggest a walk or going for a ride to get out of the house.
• Socialize. Invite a friend over and talk about something that is completely unrelated to their condition.
  

Reprinted with permission from Patient Resource LLC.

Caregiving is a mentally and physically exhausting responsibility, and you won’t be any good to your loved one if you aren’t good to yourself. Eat right, exercise and get enough sleep.

Caregivers often feel that by focusing on themselves, they are being selfish. Actually, it has the opposite effect, allowing you to be more alert and focused on your caregiving responsibilities. Keep up with your favorite hobby. Lose yourself in a good book or movie. And don’t feel guilty when you enjoy yourself. Everyone deserves a diversion.

You play an essential role, but it is important to realize you cannot carry the weight of the world on your shoulders. Accepting offers of help from others will free up your time for the most important duties. Additionally, when you allow friends and family members to pitch in, they feel as if they are making a valuable contribution.

It may be helpful to talk with others who are facing the same challenges as you. Search for support groups for caregivers, either in your local area or online.

If you are due for your annual physical exam, or some form of cancer screening (mammogram, colonoscopy, etc.), keep your appointment. It is crucial that you not postpone it.

Reprinted with permission from Patient Resource LLC.

Children and parents are participating in something that may lead to advancements in treatments, and help other families and future generations. 

Many drugs prescribed for children are based on research from adult clinical studies and physicians are challenged with adjusting the dosage for children. Most medications prescribed for children have not been tested with children.

Children are not little adults. Pediatric clinical studies help provide vital data so that children can be treated based on their special developmental needs.

One size does not fit all. Pediatric research can help uncover effective therapies for infants, children, and adolescents.

It’s essential for the research team, parents, and family members to hear the perspective of children as patients.

Including them in the conversation helps children take an active role in their clinical study. Depending on their age, these kids will have a lot to say!

It's important to foster an environment where children feel comfortable asking questions, talking about how they are feeling, and voicing any concerns.

Hear first-hand what children have to say about being in a study.

Every pediatric clinical study has its own research team. These team members can include doctors, nurses, research scientists and coordinators, and pharmacists. The size of the team and the members will vary depending on the type of clinical study in which your child participates. The research team works in close partnership with you and your child. 

Asking questions can empower parents. Take as much time as necessary to speak with doctors and members of the research team in order to make an educated decision on your child’s participation in a clinical study. 

Questions such as "What is the length of the study?", "What are the potential benefits and risks?", and "are there any costs involved?" are just a few of the important details parents need to know. 

It’s important for parents to know about and understand the rights put in place for their child. Parents and their children have the right to be fully informed on what occurs before, during, and after a pediatric clinical study. If a child is mature enough to take part in the process, they are asked for their assent to take part in the clinical trial. This is meant to be an ongoing conversation between the child and research team. 

The risks for patients include:

• Potentially greater time commitment as there may be more tests and visits
• No improvement in their condition
• Unpleasant, serious, or life-threatening side effects

You will continue to be your patient’s main healthcare provider. To provide your patient with the best coordinated care during the trial, please notify the Study Doctor/Investigator if there are any major changes in your patient’s general care and health. 

We also appreciate your keeping the trial in mind when seeing patients, and referring newly diagnosed patients to the Study Doctor/Investigator.

Explain the trial to potential patients. It is often helpful for patients to understand what they can do after they have been diagnosed. Walking through the options available to them may be reassuring and empowering.

If you think that your patient may be a good candidate for the trial, you may want to explain what clinical trials are and why they may be appropriate for your patient.

To help the Study Team provide the best care to your patient in the clinical trial, contact the Study Doctor if:

• Your patient has a new health issue
• Your patient is starting a new medication that is on the prohibited medications list
• You have questions, concerns, or other information that may impact your patient’s care in the trial

To help you provide the best general care to your patient during the clinical trial, the Study Doctor may contact you:

• If any new medical concerns arise (e.g., reactions to the study medication)
• About questions, concerns, or other information that may impact your patient’s care in the trial
• If there is any change in status, such as your patient leaving the study or when the study ends

By participating in the clinical trial, your patients will receive:

• Access to study-related medical care at no cost
• Opportunity to participate in research that may potentially benefit others