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clinical trials ontario: 5 things to consider before joining a clinical trial

there are a lot of advantages to clinical trials, including offering access to new treatments and improving outcomes for patients. here's what you should know before you sign up.

you can withdraw from a clinical trial at any time.
clinical trials are done to provide research data on the treatment being tested. getty
clinical trials may provide access to urgently needed and sometimes life-changing therapies and lead to better outcomes for current and future patients. before you join a clinical trial, it is important that you know what is involved to make the best decisions about your participation.

your participation in a clinical trial is voluntary

your participation in a clinical trial is always voluntary. if you are thinking about participating in a clinical trial, it is important that you are provided with the time to ask questions and the information to make an informed decision that is right for you.
a key part of enrolling in any clinical trial is something called “informed consent.” informed consent is a process in which you are given a document — usually called the “informed consent form,” or the “consent form” — which should provide all relevant information about the clinical trial and be written in a way that is understandable to you.
you can choose to end your participation in the clinical trial at any time without having to provide a reason. if you do withdraw from a study, you may be asked questions about your experience in the study, and to have laboratory tests and physical examinations considered necessary to safely stop your participation.

you should understand the purpose of the clinical trial

ultimately, the goal of  clinical trials  is to improve medical treatments and peoples’ health and well-being. they are done to provide research data, or evidence, about the treatment tested. however, in different clinical trials, the evidence, or results, can be used in many ways.

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for example, with very new or experimental therapies, the purpose of the clinical trial can be to provide information about an intervention’s safety and side effects. other trials might aim to test how long the effects of an intervention last or determine the best dose of a medication.
this information should be disclosed to you in the informed consent form before you begin a trial. if anything is not clear, you should ask questions until you have a good understanding of the purpose of the trial.

there are risks and benefits to being in a clinical trial

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 may impact you. potential benefits and risks will be dependent on the clinical trial and will be different for each one.
it’s important to ask questions about potential benefits and risks of the clinical trial you are considering, until you feel satisfied.

how to find out if a clinical trial is reputable

there are some things that you should look for in helping to determine if a clinical trial is a reputable or credible trial:
  • you should never be asked to pay to participate in a clinical trial. (see the next consideration — you may have some out-of-pocket costs.)
  • ask about the qualifications of the clinical trial team. often clinical trials teams have worked in or studied the area of the clinical trial or may have an affiliation with an academic institution such as a university.
  • make sure the 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 it reviews all clinical trial applications. to find out if the trial application was reviewed, you can ask the clinical trial team, or, for those in canada, you can look on the health canada website.
  • you should ensure that the clinical trial was reviewed and approved by a research ethics board (also called “reb” for short). clinical trials must undergo research ethics review from an reb, whose members look at the clinical trial from the perspective of protecting the rights and well-being of people who participate in research.

consider the amount of time that participating in the clinical trial will take, and potential costs.

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while you should not be asked to pay to participate in the clinical trial, there may be costs associated with hospital visits, such as parking or transportation, or food 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 because of participation.
but monetary costs are not the only things to consider when deciding whether to join a clinical trial. you may also wish to think about how participation might impact your normal routine. understanding the time commitment that you will need to make and how it will affect your day-to-day activities will help you make your decision.

where can you learn more about clinical trials?

to learn more about what clinical trials are, how they are designed, how to find them and things to know when you’re in a clinical trial, visit  clinical trials ontario’s education modules .

feeling overwhelmed by research-related terms like “intervention” or “informed consent”? clinical trials ontario also has an online glossary that provides definitions of terms related to clinical trials.

may 20 is clinical trials day. for more information and to get involved, visit clinical trials ontario.

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dawn richards is the director of patient and public engagement at clinical trials ontario.

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