Clinical Trials Ontario

Learn About Clinical Trials

CTO provides resources for patients and the public on how to find trial opportunities and what to expect if they choose to participate. CTO does not do clinical trials. The general information we provide is meant to be educational in nature and reflects what we have learned from different sources, including people with different experiences related to clinical trials and those who are part of patient organizations and health charities.

Contents

Learning the Basics

Clinical trials are a type of research. They involve people and test health-related “interventions” to see how they work (see the next paragraphs for more on interventions). Clinical trials often answer questions like: Is the intervention safe? Does the intervention improve or cure disease, or help people live longer with disease than other treatments? Does the intervention help people feel better?

There are many types of interventions tested in clinical trials. While we often think about clinical trials being done to test drugs, they also test devices, genetic therapies, natural health products, psychotherapies, lifestyle and preventive care interventions, and many other things.

The interventions studied in clinical trials can be very experimental, with little to no evidence about how they might work in people (e.g. new drugs). Or they may already be commonly used by people but more evidence is needed about how they work.

Clinical trials are carefully designed and planned to make sure that risks to the people participating are minimized to the extent possible, and that the questions asked about the intervention(s) can be answered when the trial is finished.

Clinical trials study different treatments or interventions on their own or in combination with others and might include drugs, devices, surgery, radiation therapy, diagnostic procedures, diet and lifestyle.

Clinical trials are done to provide research data, or evidence, about the intervention(s) tested. This evidence helps in deciding what therapies or other interventions might work best for people. Ultimately the goal is to improve medical treatments and peoples’ health and well-being.

The evidence, or results, from clinical trials can be used in many ways. With very new or experimental therapies, clinical trials can provide information about an intervention’s safety and inform decisions about whether to keep testing the intervention. The results of clinical trials are also used by companies as they develop new therapies, by doctors and other health care professionals in their daily practices, and by regulatory agencies (e.g. Health Canada) to decide which drugs and devices are safe and effective for Canadians. Clinical trial results can also help decision-makers decide on how healthcare and healthcare resources or healthcare dollars should be allocated.

Clinical trials are done at many different places. Some examples are hospitals, private companies, doctors’ offices, community clinics and dental offices.

There are some things that you should look for in helping you determine if a clinical trial is a reputable or credible clinical trial:

  • If you are asked to pay to participate in a clinical trial. While you may be required to pay for expenses such as travelling to your appointments, parking, etc., you should not be asked to pay to participate in the clinical trial.
  • The qualifications of the clinical trial team. Often people on the clinical trial team have worked in or studied the area of the clinical trial or have an affiliation with an academic institution such as a university.
  • If the clinical trial application was reviewed by a regulatory agency. Examples of regulatory agencies are Health Canada and the US Food and Drug Administration. Health Canada’s role is to ensure Canadians have access to safe and effective drugs and health products, and they review all clinical trial applications.
  • If the clinical trial was reviewed and approved by a research ethics board (also called “REB” for short). The REB reviews proposed clinical trials with an aim to make sure they are acceptable from a Research Ethics Board perspective.
  • If the clinical trial was reviewed and approved by the institution or organization (e.g. hospital) where the clinical trial is taking place.
  • If the clinical trial is being offered in another country, this list of things will still be helpful for you to consider.
  • In the two videos below, Ms. Sharon Frietag talks about the research ethics process and why it exists. She introduces the research ethics board, including its role and composition.

Clinical trials are designed to answer specific questions about an intervention. They are usually designed by a group of people that can include researchers, doctors, scientists, statisticians, sponsors, and – more and more often – patients and/or caregivers.

There are different types or designs for clinical trials. The design will depend on many things, including what is already known about the intervention(s) and what questions need to be answered.

We provide here a summary of the different types of trials by phase, although there can be differences in design depending on the disease or health condition being studied.

Phase 1

These trials are also sometimes called ‘first in humans’ because it is usually the first time the intervention is tested in people. These trials aim to establish the safety, dose and side effect information of the intervention in a small number of participants (usually 20-80 people).

Phase 2

These trials aim to ensure the intervention does what it is supposed to do and to determine if the dose should be changed, and to continue to learn about potential side effects. This phase is carried out in a larger number of participants (about 100-300 people).

Phase 3

These trials are ‘randomized clinical trials’ and test how long the effects of an intervention last, and continue to learn about potential side effects. There are a large number of participants in this phase (usually 1000s of people). You can read more about randomization below.

Phase 4

These trials are also called post-marketing surveillance because they involve monitoring an intervention after it is being sold (that is, on the market). This phase studies long term effects and any side effects on a very large group of people.

In this video, Ms. Sharon Frietag talks about types of clinical trials and provides information about the different phases of therapeutic trials, their goals and how they work.

A common type of clinical trial is a “randomized” clinical trial. These are typically called “phase 3 trials”. In randomized trials two or more interventions (or treatment arms) are being compared to each other. When a trial is randomized, participants are assigned by chance to one of the interventions (or treatment arms). This helps to ensure the result of the trial is not biased.

There are other types of trials that are not randomized and participants know what intervention or treatment they will get if they participate. These are typically phase 1 or 2 trials and are done with treatments that are still in early testing for safety and effectiveness. Or they may be phase 4 trials that usually happen after a treatment is in widespread use.

Participation in a clinical trial is voluntary. If you are thinking about participating in a clinical trial it is important that you are provided with enough information to make an informed decision, an opportunity to ask questions and talk to others you may choose to (e.g. your family or friends) and the time to make a decision that is right for you.

A key part of the informed consent processes for most clinical trials is a document called the ‘informed consent form’ or ‘consent form’. This document should provide all relevant information about the clinical trial and be written in a way that is understandable to you. You should be given enough time to read it and ask any questions you may have. If you agree to participate, you may be asked to sign the consent form and should be provided with a copy of the form for your own keeping.

Informed consent is an ongoing process throughout a clinical trial. You can withdraw your consent to participate at any time. If you are in a clinical trial and your doctor or study team learn new information that might affect your willingness to continue to participate (e.g., new safety information about the intervention), you should be provided with this information.

A clinical trial protocol contains detailed documents with information on why the trial is being done, how the trial will be done, how the results will be gathered, analyzed and shared, and who is involved. The typical parts of a protocol include the following information about a clinical trial:

  • Scientific and medication justification
  • Key measurements or endpoints of the trial
  • Who can and can’t be in the clinical trial also called the eligibility and ineligibility criteria
  • The assessments that will be undertaken, including what kind, when, and the type of Assessment (for example, blood tests, doctors visits, questionnaires, etc.)
  • A sample informed consent form
  • The number of participants needed and why
  • How results will be analyzed and shared
  • Safety reporting information
  • What treatments will be used and how, and how or if any adjustments to treatment will be made
  • Data that will be collected

Finding a Trial

Some of the reasons people look for a clinical trial may include: living with a condition or a disease; having a loved one such as a family member or good friend who lives with a condition or a disease; and being interested in research. Sometimes healthy participants are provided with compensation for their participation in a clinical trial and this may be motivation for some people to participate.

While participation in a clinical trial is one option, the other options to consider may be:

  • Receiving no treatment.
  • Receiving standard treatment or a different form of treatment than the one you are currently on if you live with a disease or condition.
  • Participation in a different research study.
  • Talking to your doctor about potential known benefits and risks of these other options (including no treatment) may be helpful.

People find clinical trials in different ways.

Some people talk to their health care providers about finding a clinical trial. Health care providers may have different levels of knowledge and comfort talking about clinical trials. Depending on your health care provider’s experience or resources, they might be able to provide more information for you or direct you to a resource or person who can.

Some health charities and patient organizations have information about specific clinical trials on their websites (usually under a clinical trials or research section) or have a phone number you can call to speak to someone to help you find a clinical trial.

Hospitals, including both community and academic hospitals, carry out clinical trials and may be a source of information. Some hospitals provide information directly on their website about local clinical trials. If you phone or email the hospital looking for more information, you may have to make more than one phone call or send more than one email to find the right person to help you.

Some people use websites to help them find a clinical trials. Clinical Trials Ontario has developed a website to help you find a clinical trial, which you can link to here. Clinical Trial Ontario’s clinical trial finder uses a well-known website called Clinicaltrials.gov where many clinical trials from around the world are registered and detailed clinical trial information is provided. If you find a clinical trial you are interested in, the contact information is provided on the site.

You may also hear ads about clinical trials on the radio, and see them on tv, in the newspaper, on public transportation, in a doctor’s office, or in a hospital. Contact information is provided in these ads for people who are interested in learning more about these clinical trials.

There are some things that you should look for in helping you determine if a clinical trial is a good clinical trial for you, and may include:

  • If you meet the eligibility criteria to participate in the clinical trial. In order to be accepted to participate in a clinical trial, you must meet certain criteria.
  • If you are asked to pay to participate in a clinical trial. While you may be required to pay for expenses such as traveling to your appointments, parking, etc., you should not be asked to pay to participate in the clinical trial.
  • The qualifications of the clinical trial team. Often people on the clinical trial team have worked in or studied the area of the clinical trial or have an affiliation with an academic institution such as a university.
  • If the clinical trial application was reviewed by a regulatory agency. Examples of regulatory agencies are Health Canada and the US Food and Drug Administration. Health Canada’s role is to ensure Canadians have access to safe and effective drugs and health products, and they review all clinical trial applications.
  • If the clinical trial was reviewed and approved by a research ethics board ( also called “REB” for short). The REB reviews proposed clinical trials with an aim to make sure they are acceptable from a Research Ethics Board perspective.
  • If the clinical trial was reviewed and approved by the institution or organization (e.g. hospital) where the clinical trial is taking place.

There may be different reasons why you are not able to find a clinical trial. For example, there may be a clinical trial available but it is not at a location close to you or there may not be an intervention available yet to be tested for your disease or condition.

If there is a clinical trial available but it is being run at a location that is not close to you, there may still be possible ways to be in the study. You may wish to reach out to the study team contact to see if this is a possibility and how or if this might affect you (for example, will you have to pay for travel or accommodation?). You might also simply wish to keep up to date on research and check from time to time if there is a clinical trial available for your disease or condition.

Clinical Trial Finder

The Clinical Trials Finder is a search tool created to help you look for a clinical trial. The source of information is a clinical trials database used by clinicians, researchers and companies around the world to provide public access to information about clinical trials. (*Note that not all trials are listed on the site.)

Deciding Whether or Not to Participate

Yes. You can say no to a clinical trial that your health care provider offers you if you don’t feel that it’s the right choice for you. Your relationship with your health care provider should not change no matter what you decide about a clinical trial.
There is usually a contact person who is part of the research team conducting the clinical trial who will be able to answer any questions you might have about it. Later in this section, we provide you some questions that you might consider asking about the clinical trial you are interested in.

There may be costs associated with hospital visits, such as parking or transportation, or snacks/meals during your stay. You may also need to miss or take time off work to participate in the study or if you experience side effects as a result of participation. Other costs involved in your participation could be for extra costs not covered by your health insurance plan (if you have one), for example medications or treatments (such as physiotherapy) to treat side effects that you may experience. If you have private health care insurance, the insurer may not pay for these added costs.

You should not be asked to pay to participate in the study itself.

It is up to you to decide if the potential benefits of the clinical trial outweigh the potential risks, as well as to consider how not participating in the clinical trial at all may impact you. Potential benefits and risks will be dependent on the clinical trial and will be different for each clinical trial.

The informed consent form will have the potential benefits and risks of the clinical trial described.

You should ask your doctor or members of the study team any and all questions about potential benefits and risks until you feel satisfied.

When you participate in a clinical trial you may receive treatment that might affect your future medical care. This will depend on the type of treatment received, and the benefits or side effects of the intervention. For example, if you experienced side effects, your routine medical care may change to include treatments for those side effects, for a short or long period of time. Or the treatment you received on a trial may affect your access to other treatments in future.

You may also need additional follow-ups for study purposes for some time after the study and receive some tests or examinations related to this follow up.

Participation in the clinical trial may also limit you from participating in other clinical trials.

Clinical trials are a type of research. There are possibilities of experiencing benefits and risks, not all of which are completely understood or known until clinical trials are performed for an intervention. A number of precautions are taken to minimize risk to the extent possible. The clinical trial physician will closely monitor participants.

Clinical trial participants have experienced both benefits to their disease/condition and quality of life, as well as a range of side effects that have either gone away quickly or been serious, long lasting, and permanent. Some participants have died in clinical trials.

Some questions that you might wish to ask about the clinical trial include:

  • Am I eligible for the clinical trial?
  • What is the name of the study physician? Who is funding the clinical trial? What are the credentials and experience of the research team?
  • What is the study intervention and what are the procedures or tests that will be involved?
  • What treatments will I get during the trial, how will they be administered and how often will they be administered? If I’m on treatments now, how are they different or will I have to change my current treatment?
  • How many appointments will I have during the study and how long will they be? Will someone need to accompany me to my appointments?
  • Will I need to fill out a diary, surveys, etc.?
  • Who will I see during the clinical trial? Will I see my own doctor still?
  • Is there a chance I might receive a placebo? What happens in terms of randomization?
  • What are possible benefits and risks (including long-lasting ones such as reproductive risks)?
  • When will the clinical trial start and how long will it last?
  • How many people will be in the clinical trial?
  • Do I need to pay for any part of the clinical trial?
  • Will I need to travel? If I do, how far and how often and will I be reimbursed for travel, parking, and related costs?
  • How will my participation in a clinical trial affect my spouse, children, or family members?
  • What other choices are there for me if I choose not to participate in the clinical trial?
  • Who do I contact during the clinical trial if I have any questions or issues?
  • What happens if I want to leave the clinical trial before it’s finished?
  • If the treatment is beneficial, can I stay on it after the trial is finished? If there is no benefit to the clinical trial, what happens then?
  • Will there be any short term or long term follow up after the clinical trial, and if so, by whom?
  • Will results from the clinical trial be shared with me?

As you are asking questions about the clinical trial, you may wish to consider how participation might impact your normal routine. Understanding the commitment that you will need to make to the clinical trial and how this will affect your day to day activities will help you make your decision.

Download a PDF Version clinical trial Questions

Participating in a Trial

The informed consent will provide you with specific contact information depending on the type of question(s) or concern(s) you have about the clinical trial. If you have questions about the clinical trial itself, this will likely be the study doctor. If you have questions about your rights as a participant or about ethical issues related to this study, you will be directed to talk to someone who is not involved in the study at all, such as someone from the Research Ethics Board.
Whether or not you’re in a clinical trial, you may experience side effects from treatments. If you are in a clinical trial, any physical side effects or unexpected health events should be reported to the study doctor or study team. If you need emergency health care for any reason and are in a clinical trial, it will be helpful to have information about the clinical trial with you when you seek care.

You can choose to end your participation in the clinical trial at any time without having to provide a reason – this is called withdrawal. If you choose to withdraw from the study, you are encouraged to contact the study doctor or study staff to let them know your decision or to ask them further questions before you make a decision.

If you do withdraw, you may be asked questions about your experience with the intervention, and to have laboratory tests and physical examinations considered necessary to safely stop your participation.

You may also be able to withdraw your permission to use information that was collected about you for the clinical trial and this would mean that you withdraw from the clinical trial.

If you stop participating in the study, you will continue to be seen by your regular medical team and receive your routine medical care.

If you left the study because of side effects, you may need treatment for these side effects, which may or may not be covered by private health insurance (if you have it).

After the clinical trial, you will continue as normal to be seen by your regular medical team and receive your routine medical care. If you experience side effects after the study, you may need treatment for these side effects, which may or may not be covered by private health insurance (if you have it).

You may also need to continue to be followed up on for study purposes for some time after the study and receive some tests or examinations related to this follow up.

A placebo is an inactive therapy (such as a drug, natural health product, or device) that looks like an active therapy. A placebo is not intended to have any effect on the condition being studied and is used to make the results of the study more reliable.

Generally, requests to reveal your assignment are not considered until the clinical trial has been completed and the results are known.

In some instances participants believe they are able to guess the arm of the clinical trial they are participating in given the results they experience in the clinical trial.

You can share your participation in a clinical trial and information about it with anyone you wish. You should have a copy of the informed consent form from the clinical trial that describes the clinical trial in detail. It is important to share information with your health care providers about any medication you may be on for the clinical trial. You may wish to share information from the informed consent form, or the form itself, with your family doctor or your specialist.

Finishing the Trial

As a clinical trial participant, you should be informed of the results of the clinical trial once the entire study is complete. You should speak to the study doctor or study team about how to obtain this information when the study is completed.

Depending on the study design, you may be aware from the beginning of the clinical trial which treatment group you are in, for example, for:

  • Open label, randomized studies – you will know which treatment group of the clinical trial you are in from the start;
  • Single-blind studies – the study doctor and staff will know which treatment group you are in, but you will not; and,
  • Double-blind studies – neither you, the study doctors or staff, or your usual health care providers will know which treatment group you are in.
While your group assignment may be identified if medically necessary, your assignment may not be shared with you until your participation in the study is complete or the study is complete and results are known.
You should speak to your doctor or specialist about your concerns.

After the clinical trial, you will continue as normal to be seen by your regular medical team and receive your routine medical care. This routine medical care may be changed by your participation in the clinical trial depending on the benefits or side effects of the intervention that you experience. For example, if you experience side effects, your routine medical care may change to include treatments for those side effects, for a short or long period of time.

You may also need to continue to be followed up on for study purposes for some time after the study and receive some tests or examinations related to this follow up.

You may not be able to receive the study intervention after your participation in the study is completed. There are several possible reasons for this, some of which are:

  • The intervention may not turn out to be effective or safe.
  • The intervention may not be approved for use in Canada.
  • Your health care providers may not feel it is the best option for you.
  • You may decide it is too expensive and insurance coverage may not be available.
  • The intervention, even if approved in Canada, may not be available free of charge.

The study doctor will talk to you about your options.

Speak to your health care provider about your options. There may be other interventions for you or there may be other research studies for you to consider.

Glossary of Clinical Trial Terms

An unintended medical event that may happen during a clinical trial and that may or may not be expected and may or may not be due to the intervention(s) being tested. Adverse events can be mild or less serious (for example a rash) or more severe or serious (for example, death). All adverse events that happen during a trial are reported whether or not they are caused by the intervention. For some people, considering potential adverse events is important when they are thinking about participating in a clinical trial.
A group of participants in a clinical trial that receive a specific intervention (or no intervention) based on the protocol of the clinical trials.
In a clinical trial, this is a flaw in the study design or in how information is collected or interpreted. A bias may lead to incorrect conclusions being drawn from the study.
If a trial is “blinded” one or more individuals do not know what treatment group participants are randomized to. When participants are “blinded” they do not know which intervention they are receiving. A “double-blinded” study is when both the participants and the study team do not know which treatment arm the participants are in. Blinding is used to help ensure the assessment of outcomes (e.g., disease status, side effects) of a trial are not biased by people knowing what treatment participants receive.
Another word for effectiveness, which means the ability of an intervention to produce a desired effect or do what it is supposed to do.
The ‘qualifications’ set that determines whether or not the trial is right for you. These qualifications may include a disease or condition, a certain age range, living in or near a specific location, a specific ethnicity, etc. Inclusion criteria are the characteristics needed to be part of the clinical trial. For example, for a cancer clinical trial, this might be specific genetic characteristics. Exclusion criteria are characteristics that don’t allow participation in the clinical trial, for example, ‘pregnancy’ or a specific health condition.
A result that is measured and is used to see whether the clinical trial intervention is beneficial or not. Some examples may include whether a participant contracted a disease, how long a participant survived after receiving a treatment, etc.
Sometimes also called compassionate use. This is a way for patients to access interventions that are not yet approved by a regulatory agency, and in circumstances where there are not comparable or satisfactory treatments options available outside of a clinical trial.

Participation in a clinical trial is voluntary. If you are thinking about participating in a clinical trial it is important that you are provided with enough information to make an informed decision, an opportunity to ask questions and talk to others you may choose to (e.g. your family or friends) and the time to make a decision that is right for you.

A key part of the informed consent process for most clinical trials is a document called the ‘informed consent form’ or ‘consent form’. This document should provide all relevant information about the clinical trial and be written in a way that is understandable to you. You should be given enough time to read it and ask any questions you may have. If you agree to participate, you may be asked to sign the consent form and should be provided with a copy of the form for your own keeping.

Informed consent does not always need to be provided in a written consent form. It may be provided in another, non-written form, and however this happens, it is always approved by a Research Ethics Board.

Informed consent is an ongoing process throughout a clinical trial. You can withdraw your consent to participate at any time. If you are in a clinical trial and your doctor or study team learn new information that might affect your willingness to continue to participate (e.g., new safety information about the intervention), you should be provided with this information.

Clinical trials study different treatments or interventions on their own or in combination with others. Different intervention types studied in clinical trials may include:

  • A drug such as a pill, an intravenous treatment, etc.
  • A medical device such as a pacemaker or an insulin pump
  • A type of surgery
  • Radiation therapy
  • A diagnostic procedure
  • A diet and lifestyle change such as exercise
Another word for blinding.
  • Principal Investigator – The person responsible for the study and may be a physician or a dentist or another health professional.
  • Clinical research coordinator – The individual who is responsible for the day-to- day coordination of the clinical trials including planning and scheduling of participants and collecting data. They are often the person that participants interact with the most on the study team.

Other research site staff may include:

  • Research nurse – A nurse who is part of the research team, and may also be a clinical research coordinator for the study.
  • Genetic counsellor – A healthcare provider with an education in both genetics and counselling.
  • Social worker – A professional who helps people solve and cope with challenges they face in their lives.
  • Dietitian – An individual educated about nutrition and its relation to health.
  • Pharmacist – A healthcare professional who works with medicines and provides them to individuals with a medical prescription and who can also provide counselling services related to medicines.
  • Nurse practitioner – A nurse who also has an advanced degree and other clinical training, and is often allowed to provide primary care and other medical services to patients.
  • Patient partners – People who live or have lived with a health condition or who have an experience in the healthcare system, and who bring this perspective to the clinical trial team.
An extension to a blinded placebo-controlled clinical trial whereby all participants receive the active study drug or treatment, no matter which study treatment arm they started in. When the extension trial starts, participants and the study team are considered ‘unblinded’ since they know all participants are receiving the active study drug or treatment (vs. the placebo).
A characteristic(s) being measured in a clinical trial that is related to health. Some examples may include disease status (e.g., if the disease being studied gets worse or better), survival status (how long participants live), health status (fatigue or pain) and side effects.
A placebo is an inactive therapy (such as a drug, natural health product, or device) that looks like the active therapy that is being tested in the clinical trial. A placebo is not intended to have any effect on the condition being studied and is used to ensure the results of the study more reliable by removing any bias associated with people knowing what treatment participants receive.

A clinical trial protocol contains detailed documents with information on how and why the trial is being done, how the trial will be done, how the results will be gathered, analyzed and shared, and who is involved. The typical parts of a clinical trial protocol are:

  • Background scientific and clinical information
  • Justification on why the trial is important
  • Key measurements or endpoints of the trial
  • Who can and can’t be in the clinical trial also called the eligibility and ineligibility criteria
  • What treatments will be used and how, and how or if any adjustments to treatment will be made
  • The assessments that will be undertaken, including what kind, when, and the type of assessment (for example, blood tests, doctors visits, questionnaires, etc.)
  • A sample informed consent form
  • The number of participants needed and why
  • How results will be analyzed and shared
  • Safety reporting information
  • Data that will be collected

Another way of saying you get there by chance. A common type of clinical trial is a “randomized” clinical trial. These are typically called “phase 3 trials”. In randomized trials two or more interventions (or treatment arms) are being compared to each other. When a trial is randomized, participants are assigned by chance to one of the interventions (or treatment arms). This is important in helping to ensure the results of the trial are not due to health professionals or participants choosing what treatment arm they want to participate on.

An independent committee of people with different expertise (for example, law, medicine, ethics, community, etc.) that reviews the ethical acceptability of research involving humans.. The REB reviews all study materials including protocols and information or materials given to potential or actual participants with a view to ensuring participants are properly informed and free to make a voluntary decision about participating, and that a study’s potential risks are balanced with potential benefits. The REB continues to review information about the study as long as it is ongoing, including any adverse events and changes to the study along the way.

The term sponsor is used in two ways in Canada. Health Canada considers the ‘sponsor’ of the trial the organization or individual that is responsible for the regulatory submission and overall conduct of the trial. This can be a company, a hospital, a research group or a clinician researcher. The word sponsor is also used in Canada to describe who is funding the clinical trial. This might be pharmaceutical or medical device company, for example. This same company may or may not be the regulatory sponsor with Health Canada.

You can choose to end your participation in the clinical trial at any time without having to provide a reason – this is called withdrawal. If you choose to withdraw from the study, you are encouraged to contact the study doctor or study staff to let them know your decision or to ask them further questions before you make a decision.

If you do withdraw, you may be asked questions about your experience with the intervention, and to have laboratory tests and physical examinations considered necessary to safely stop your participation.

You may also be able to withdraw your permission to use information that was collected about you for the clinical trial intervention.

The study doctor may stop your participation in a study early, and without your consent, for reasons such as:

  • The study intervention does not work for you
  • You are unable to tolerate the study intervention
  • You are unable to complete all required study procedures
  • New information shows that the study intervention is no longer in your best interest
  • The study doctor no longer feels this is the best option for you
  • The Sponsor decides to stop the study
  • The Regulatory Authority/ies (for example, Health Canada) or research ethics board withdraw permission for this study to continue
  • Your group assignment becomes known to you or others (like the study doctor or study staff)
  • If you are female and plan to or become pregnant

If this happens, it may mean that you would not receive the study intervention for the full period described in this consent form.

If you are removed from a study, the study doctor will discuss the reasons with you and plans will be made for your continued care outside of the study.

#TalkClinicalTrials

The #TalkClinicalTrials blog series explores different perspectives related to clinical trials. If you’ve personally taken part in a trial, supported a loved one who has, or been involved in some aspect of the clinical trials process, we’d love to hear your story. Email info@ctontario.ca or join the #TalkClinicalTrials conversation on social media.

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