Clinical trials are research trials that include human participants. Clinical trials can investigate how an experimental medication 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:
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:
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:
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 medication(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 medication(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, State / Territory, and local requirements regarding the protection of human subjects.
Before a study begins, the research plan is reviewed for approval by a Human Research Ethics Committee (HREC). An HREC is a group of doctors, researchers, community-members, and others who are independent from the group running the clinical trial. The HREC’s job is to protect the rights and welfare of participants in clinical trials.
Ideas for clinical trials usually come from researchers, and often build on existing research.
Clinical trials are typically classified into four phases:
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 trials 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 medication or something else, but trial investigators do. In a double-blind trial, neither the participants nor the investigators know who is receiving the trial medication .
Some clinical trials have a control group. This is the group of participants in a clinical trial who receive either an approved treatment for their condition or a placebo. This group is compared to participants in another group who are given the experimental medication or treatment. In some clinical trials, the control group is compared to more than one treatment group.
A placebo is an inactive medication sometimes given to a control group. Placebos are used so investigators can compare it to the experimental medication being studied. In cancer trials, patients are provided with at least the standard of care and a placebo is not used.
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 medication or treatment. In some trials, 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 clinical trial
About study treatment and study appointments
About side effects
After the trial is completed
Here are some suggestions
Yes. Most clinical trials provide short-term experimental treatments related to a designated illness or condition, but do not provide extended or complete health care. In addition, by having the participant’s doctor coordinate with the research team, the participant can help ensure that other medications or treatments will not conflict with the clinical trial protocol.
Clinical trials are not treatment, but are a type of research conducted to answer certain medical questions. Clinical trials typically study how an experimental medication might act in the body and affect a disease.
A clinical trial sponsor refers to who is backing the research. Most clinical trials are sponsored or funded by either a pharmaceutical or medically-focused company or the government. A few clinical trials are sponsored by non-profit organizations and individuals.
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:
Trial-required medications, study visits, and any medical tests specifically needed for this study are provided at no cost to you or your insurance company. You may be responsible for other costs (for example, tests you would receive as the usual care for your disease), some of which may be covered by your insurance. Travel reimbursement may also be possible. Information about other potential costs is included in the informed consent form and the study team will answer any questions about cost that you may have.
It is possible to be reimbursed for certain travel costs (e.g., gas, parking, and public transportation) that were incurred because of participation in a clinical trial. Travel reimbursement relevant to a particular trial is described in the Informed consent form, which patients review and sign before a trial begins. Talk to your study team for more information.
Enrolling in a clinical trial is a decision that a patient usually makes in consultation with the doctor and their loved ones. BMS Clinical Trials offers tools to help inform those decisions.
Many Bristol Myers Squibb trials presented on BMS Clinical Trials 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.
No, there are no commissions or rewards paid to anyone for enrolling patients.
Each trial is different, so how long you take part in a trial will also differ by trial. The informed consent form and the team will tell you how long you will be involved in a trial.
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.
Speak with your physician about potential to access experimental medication.
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.
Randomisation occurs when a participant in a clinical trial has their treatment selected by chance (not by choice). This is similar to being chosen by flipping a coin. For example, if an experimental medication is being compared to a currently available approved medication or placebo (an inactive substance that contains no active medicine but looks exactly like the experimental medication), there may be 2 treatment 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 available approved medication 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 them.
This will vary depending on the trial. There may be self-reporting involved, continuing with regular doctor appointments and other factors. The Informed consent form (ICF) will highlight those commitments. The study team can also answer any questions.
This will vary depending on the clinical trial. The Informed consent form (ICF) will detail the visit schedule and what will occur at each visit. The study team can also answer any questions.
This will vary depending on the trial and the experimental medication 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 questionnaires you do not seem to qualify for any BMS trials, you have the option to see trials from other pharmaceutical companies that are running clinical trials related to your condition from data provided by clinicialtrials.gov or discuss with your health care provider.
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 jewellery.
Reprinted with permission from Patient Resource LLC.
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 favourite 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 medications prescribed for children are based on research from adult clinical trials 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 trials 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.
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:
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.
Your practice may have the patients that clinical trial study teams are looking for. As the Primary Care Physician, you are able to help greatly by reviewing charts of patients in order to find those that have been recently diagnosed with a disease or condition.
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.
Once your patient is participating in the study, it is important to keep lines of communication open with the Study Doctor as part of providing the best coordinated care for your patient. For the best results, both the Referring Physician Team and the Study Team are encouraged to share updates regarding your patient’s health, so that appropriate, coordinated care decisions can be made.
To help the Study Team provide the best care to your patient in the clinical trial, contact the Study Doctor if:
To help you provide the best general care to your patient during the clinical trial, the Study Doctor may contact you:
Coordinated care for your patient does not have to end with the clinical trial. Work with the Study Doctor to determine what the ongoing care or treatment for your patient’s may look like.
Some clinical trials are studying medications in patients with early stages of a disease who are naïve to other treatments. Because this type of patient is less common for Study Doctors, we need the help of Primary Care Physicians to find patients for these types of trials.
By participating in the clinical trial, your patients will receive:
Yes, depending on the type of study. After your patient is enrolled in a study, he/she may be assigned either the study medication, a placebo, or the usual care, as described in the Informed Consent Form (ICF). However, please note that a placebo is not used in clinical trials for many diseases, such as cancer. In these circumstances, either the study medication or the standard treatment is provided.
The Study Doctor will monitor the patients for their disease throughout the study. There are many types of clinical trials, and the protocol for each is different so the options available to a patient who is not responding to study treatment will vary. In some trials, if the patient’s disease does not improve on their assigned trial medication, they may be offered open-label treatment, if available. In other trials, the patient might be eligible for another study therapy without having to leave the clinical trial. Patients also have the choice to leave the study at any time.
No, the Referring Physician will still be the patient’s main healthcare provider. During the study, the Referring Physician should notify the Study Doctor if there are any major changes in the patient’s general care.
The Study Doctor takes care of the patient’s study treatments and any monitoring or tests related to the study. They will also inform the Referring Physician if there are any major changes or concerns about the patient’s health.
The Study Doctor will notify you if any medical concerns arise. You may also be able to request post-appointment updates from the Study Doctor throughout the study.
