A clinical trial, or clinical research study, evaluates a potential treatment, combination of treatments or device for use in people. They are controlled, highly regulated and carefully monitored evaluations of the benefits and safety of anything used to treat humans.
Regulatory agencies like Health Canada, Australia’s Therapeutic Goods Administration and the US FDA require that clinical research trials be conducted when developing all new medical treatments, vaccines, and devices for diseases or conditions. Clinical research trials are also referred to as research trials, clinical research studies, clinical studies or clinical trials.
Many people are involved in clinical research trials. Clinical research trials are funded or sponsored by government agencies such as the National Institutes of Health, pharmaceutical companies, physicians, health care institutions, and organizations that develop medical devices and equipment.
Government agencies, like Health Canada, Australia’s Therapeutic Goods Administration and the FDA oversee and monitor the clinical research trials. Independent Ethics Committees review and approve the trials while health care professionals perform the assessments.
Clinical research trials may take place at several locations or sites across the world. Trial sites can be doctor’s offices, community clinics, hospitals, or universities. At each site there are several members of the research team who will work with trial participants, including doctors, nurses, and clinical research coordinators.
Each clinical research trial will have specific guidelines or criteria for who is eligible for that particular trial.
The criteria are based on things like your age, gender, medical history, diseases, or conditions. These criteria are used to determine the appropriate participants for the trial and to ensure the safety of each participant. Some clinical research trials are for specific diseases or conditions while some are for healthy volunteers.
If you are a woman you cannot be pregnant or breastfeeding if you would like to participate in a clinical research trial. This is because researchers do not know how a trial drug or device will affect pregnancy. If you are planning to become pregnant, you should talk to your doctor before deciding to join a clinical research trial
To learn about clinical research trials in your area check out our Active Trials page . You can also use our Find A Trial Tool to search for research trials in your area that are looking for volunteers.
You do not have to participate in a clinical research trial to get treatment for your condition or disease.
If you do not want to take part in a clinical research trial, you will receive the standard medical care available to you for your condition or disease. Your doctor will be able to go over with you what treatment options are available.
Clinical research trials are divided into phases. Each phase has a specific goal or purpose. Each phase must be successfully completed before the next one is started.
Researchers will provide the trial drug to a small number of healthy volunteers to evaluate how well the drug is tolerated, determine safe dosage ranges, and identify possible side effects. These trials are designed to determine how the trial drug functions in a human body.
In this phase a larger group of participants are provided with an appropriate dose over a longer period of time. Participants in this phase all have the targeted disease or condition. Researchers will evaluate the effectiveness of the trial drug. They will also study any short-term side effects.
During these trials, the new treatment is often compared to standard treatment or a placebo (inactive substance).
Large groups of participants over several months or years will participate in Phase III trials. Researchers will evaluate if the drug remains useful or has any side effects that show up over longer periods of time.
During these trials, the new treatment is often compared to standard treatment or a placebo (inactive substance). The new treatment may also be used in combination with other drugs.
The trial drug will be used at multiple locations in hundreds to thousands of participants who have the targeted disease. These participants represent the population the drug is intended for once it is marketed.
Phase IIIb trials are also performed to gather additional safety information, evaluate the effectiveness with other diseases or conditions, and to assess a particular population such as children or elderly patients.
A drug continues to be evaluated even after it is approved for use by a regulatory authority and marketed to the public. Phase IV trials are designed to evaluate any effects over several years of treatment, to compare the trial drug to other marketed drugs, to review the impact on a participant’s quality of life, and to determine the cost-effectiveness of the trial drug.
The first thing that will happen is that you will be provided with an informed consent form (ICF) to review and sign. The ICF will provide you with a detailed description of the clinical research trial and will describe:
ICFs are reviewed by Independent Research Ethics Boards to ensure the information in the form is correct.
You will have as much time as you need to read and review the consent form. You may take home an unsigned copy of the consent form to discuss with family or friends before making your decision. You should ask the trial doctor or the research staff to explain any words or information that you do not clearly understand. A copy of the signed consent form will also be provided to you. Your participation in a clinical research trial is always voluntary.
When you sign the ICF you are telling the research team that you would like to participate in the clinical research trial. Once you sign the ICF, you will enter into a “Screening” period to determine if you are eligible for the trial. During this time, the clinical research team will:
If it is determined that you are eligible to participate you will return to the research site for additional visits as directed by the clinical research team. At these visits your health and progress will be monitored. These visits may include physical exams, blood work, or specialized assessments to monitor your disease or condition.
A placebo is an inactive substance. It has no medication (drug) in it. It looks the same as the real medication. In clinical research trials treatments are often compared to a placebo to determine how effective they are. Placebos are used in clinical research trials when there is no accepted standard of treatment and to determine the effectiveness and tolerability of the trial drug.
Placebos are also used so that neither you nor the trial doctor will be influenced by any expectations of how the drug may work.
The potential benefits of participating in a clinical research trial include:
The possible drawbacks of participating in a clinical research trial may include:
You will always be informed of changes throughout a clinical research trial and your condition will be monitored closely by health care professionals.
Adverse events are undesired effects that occur during a clinical research trial. They may or may not be related to the trial drug or device. These experiences can happen when taking a medication prescribed by your doctor or while participating in a clinical research trial. The clinical research team will monitor you closely for any immediate or long-term adverse events.
Yes. Participating in a clinical research trial is completely your choice.
You can stop participating in a clinical research trial at any time without providing a reason. Withdrawing from a trial will not affect the medical care you receive now or in the future. If you decide to stop your participation, contact the research team to let them know your decision.
When the clinical research trial is over, the trial doctor will discuss treatment options with you. In many instances, it will not be possible for you to remain on the treatment you received during participation in the clinical research trial. You may need to return to your regular doctor for treatment of your condition.
What happens with the drug in the clinical research trial will vary, and depends on what phase of the trial you participated in.
The sponsor of the trial may do more clinical research trials with the drug. In order to get approval from a regulatory authority like the FDA, a certain number of clinical research trials need to be completed and a certain number of people need to have taken the drug in order for it to be considered for approval.
Research involving humans is conducted according to strict scientific and ethical guidelines to ensure your safety. Clinical research trials are approved and monitored by an Independent Research Ethics Board and regulatory agencies like Health Canada or the FDA. The ethics board and the regulatory agency will ensure that the safety and rights of the participants are protected.
Every clinical research trial is submitted to an Independent Research Ethics Board, or ethics committee, for approval. An ethics committee must consist of a minimum of 5 people who have specific roles in the community. An ethics committee must provide approval before any trial can begin.
An ethics committee is established to ensure the rights of the participants involved in a clinical research trial are protected. The committee will review, make decisions, and provide approvals on the design of a trial as well as documents affecting a participant.
Throughout a clinical research trial the ethics committee will review and monitor any potential risks to the participants. An ethics committee can request that modifications be made to the trial, disapprove documents, or deny overall approval for a trial.
There are no costs to you to participate in a clinical research trial. All trial drug and trial procedures are provided free of charge when you participate.
Reimbursement is often provided to participants in a clinical research trial. The amount provided will vary depending on what is required for a specific trial. This reimbursement is provided to help offset the costs associated with participating, like parking or transit costs. The research staff will be able to discuss reimbursement with you, if you decide to participate in a clinical research trial.
When you participate in a clinical research trial, your personal health information will be collected as part of your trial participation. This can include things like your name, age, gender, ethnicity, and medical history. Your information will be kept confidential. You are assigned a code number when you participate in a clinical research trial. When any information about you is sent outside of the research clinic, it will only be identified with this code number. No one else will be able to do this.
The Informed Consent Form that you will receive for a clinical research trial explains how your personal information is kept confidential during your participation. The trial doctor and the research staff will go through this with you to make sure that you understand how your information will be used.
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