A clinical trial is a type of research study that tests health interventions (for example, a new medication) on people. Clinical trials can help connect you with new and emerging treatments for ovarian cancer and are very carefully designed ensuring the utmost safety and as little risk as possible to participants. The learnings from clinical trials are extremely valuable for medical advancement by answering important questions, such as: Does this new medication improve outcomes? Are there side effects and how manageable are they? Does it help people feel better? This helps healthcare providers to decide what will work best for different people in order to promote their health and well-being.
Read below to learn more about clinical trials, how to find one that is right for you, and what to expect when participating in a clinical trial. If you have questions or would like more information and support, please contact Alison Ross, Director of Disease Information and Education, Ovarian Cancer Canada at aross@ovariancanada.org or at 1-877-413-7970 ext. 237.
Are clinical trials safe?
Clinical trials are designed very carefully to ensure that there is as little risk as possible for the people participating. Pre-clinical work is conducted for many years in advance of a clinical trial (for example, on models, tissue samples, mice, etc.) to ensure that the new treatment) is safe to test on humans.
All clinical trials conducted in Canada must adhere to the Food and Drugs Regulations, Division 5. Specifically, all clinical trials conducted in Canada must:
- protect the health and well-being of the people that participate.
- be overseen by trained professionals.
- be closely monitored and side effects must be reported.
- be reviewed and approved by a Research Ethics Board.
How are clinical trials designed?
A team of people are responsible for designing clinical trials, including researchers, doctors, scientists, statisticians, sponsors, patients, and/or caregivers. There are many ways that a clinical trial can be designed as decisions about trial design will depend on many factors. Researchers begin by asking questions to establish the goals of the study. For example, what do we already know about this health-intervention?
Do clinical trials only study medications?
No. In addition to medications, clinical trials also examine many different types of health interventions, including surgery, radiation, diagnostic processes, lifestyle, and more.
Where are clinical trials done?
There are many different settings for clinical trials, including hospitals, private companies, doctors’ offices, and community clinics.
What does “Phase” mean when talking about clinical trials?
Clinical trials are categorized into different phases:
- Phase 1: The health-intervention (for example, a medication) is being tested on people for the first time. The purpose of Phase 1 trials is to establish that the drug is safe, to understand dosage, and to learn about any side effects. There are usually about 20-80 participants in Phase 1 clinical trials.
- Phase 2: Researchers want to learn if the health-intervention does what it is supposed to do. This is also when the clinical trial team will learn more about side effects and determine if the dosage needs to be changed. There are usually about 100-300 participants in Phase 2 clinical trials.
- Phase 3: Also called “randomized clinical trials”, these trials test how long the effects of the intervention last. The clinical trial team will also learn more about side effects during Phase 3 trials. There are usually thousands of participants in Phase 3 randomized clinical trials.
- Phase 4: Also called “post-marketing surveillance” because this is the phase when the intervention (for example, the medication) is monitored after it is available on the market. During this phase, the trial team studies long-term side effects on a very large group of people.
You can learn more about the phases of a clinical trial by clicking here.
What does “randomization” mean?
Randomization is a process used to compare two or more health-interventions. In randomized trials, participants are randomly assigned (by chance) to receive one of the health-interventions (for example, the new treatment being tested, or the current standard of care).
What are placebos and are they used in cancer trials?
Placebos are inactive therapies that look like active therapies. A common description of a placebo is a “sugar pill”. Placebos are very rarely used in cancer clinical trials because the new treatment is being compared to the current standard of treatment. Therefore, every person in a clinical trial for cancer does receive a real treatment (either the currently accepted treatment, or the new treatment being tested). In the very rare case that a placebo might be used, participants would be made aware during the informed consent process.
What is informed consent and how do I give it?
Participation in a clinical trial is completely voluntary and the informed consent process ensures that you are provided with all the information you need to decide if you want to take part. During this process, you should also be given the opportunity to ask questions and discuss with the people in your life to determine whether participation is right for you
An “informed consent form” is a document that provides you with all the important information about the clinical trial. The research team should give you enough time to understand the consent form and ask any questions that you might have. Your medical team will help you to understand the potential benefits and possible risks, so that you can decide if you would like to participate in the trial. If you decide to participate in the clinical trial, you will be asked to sign the consent form and you should be provided with your own copy.
The informed consent process continues throughout the clinical trial. You can choose to withdraw from the trial at any time.
What is a “clinical trial protocol”?
Clinical trial protocols contain extensive information about the clinical trial. For example, the protocol will explain why the trial is being conducted, how it will be done, how the data will be collected and analyzed, how the results of the trial will be shared, and who is involved.
How do I find a clinical trial?
There are different ways to find a clinical trial, some of these ways include:
- Talk to your health care team.
- Look on your cancer centre’s website. Consider calling or emailing your cancer centre for more information.
- Find a clinical trials navigator at your cancer centre. These are professionals who can help you find a clinical trial, explain the eligibility criteria, and help you decide if joining the clinical trial is right for you.
- Use a clinical trial finder. If you find trial finders difficult to use, please contact Alison Ross, Director of Disease Information and Education at aross@ovariancanada.org of at 1 (877) 413-7970 ext. 237.
I can’t find a clinical trial, what should I do?
There are many reasons why it may be challenging to find a clinical trial. If you are having trouble using the trial finders, please contact Alison Ross, Director of Disease Information and Education at aross@ovariancanada.org or at 1 (877) 413-7970 ext. 237.
If you find a clinical trial but the study location is far away, you can contact the clinical trial team to learn more about your potential participation.
Once I find a clinical trial, how do I know if it’s a good fit for me?
Here are a few things to consider when deciding if a clinical trial is a good fit for you:
- Determine if you meet the eligibility criteria
- You should not have to pay to participate in a clinical trial (although there may be some expenses related to travelling to your appointments, etc.)
- Determine if the clinical trial team is qualified. The clinical trial team should have related experience and an affiliation with an academic institution, and adhere to regulations and the ethics review process.
- The clinical trial application should have been reviewed by a regulatory agency (for example, Health Canada).
- The clinical trial should be reviewed/approved by a research ethics board and by the institution/hospital where it is taking place (for example, the hospital).
Learn more about research ethics boards and what they do.
Learn more about the research ethics process and why it exists
Where can I find more information about a clinical trial I am interested in?
Most clinical trials will have a primary contact person who can answer your questions.
If I decide to participate in a clinical trial, will my future medical care be affected?
- In some clinical trials, you may require additional follow-ups.
- Participation in a clinical trial may limit you from participating in other clinical trials.
- It is important to ask the clinical trial team if your eligibility could change throughout the clinical trial, and how the clinical trial may affect your future medical care.
Will I receive adequate care during a clinical trial?
Clinical trial participants are very closely monitored and significant measures are taken to reduce risk and promote safety.
Although there are risks associated with clinical trials, many precautions are taken to minimize them as much as possible. Participants are closely monitored by the clinical trial team.
In the majority of cancer clinical trials, a new intervention is being compared to the current standard of care. Therefore, every person in a clinical trial for cancer does receive a real treatment (either the currently accepted treatment, or the new treatment being tested).
What should I ask the clinical trial team?
There are many questions that you may want to ask the clinical trial team. Some questions include:
Questions to learn more about the clinical trial
- Am I eligible for this clinical trial? What might change my eligibility throughout the clinical trial?
- What is the study intervention (for example, medication)? How will it be administered? For how long? How is this treatment different from my current treatment?
- How many appointments will I have to attend? How long are the appointments? What will happen at these appointments? Where are the appointments? Should someone come with me to the appointments?
- What are the possible risks? What are the possible benefits?
- How long will this clinical trial last?
- Will there be follow-up after the clinical trial is over? Short-term? Long-term?
Questions about potential side effects
- How are “unacceptable side effects” defined?
- What should I do if I start to experience unacceptable side effects during the clinical trial?
- If I do experience side effects, how will I be treated for them?
- Who is responsible for dealing with unacceptable side effects (my family doctor, my oncology team, and/or the clinical trial team)?
- If I need medications to manage side effects, will they be supplied for me? Will there be a cost to me?
- What happens if I have to temporarily delay or stop treatment until unacceptable side effects are dealt with? Does this lengthen the trial period?
Questions about your medical care
- Will I continue to see my usual medical team during the clinical trial?
- If I am not assigned to the intervention group (for example, if I do not receive the trial drug), will I receive the current standard of care?
- Who else gets information on my health during the trial period? Will my family doctor and oncology team be kept up to date with any changes to my health?
- If my condition starts to improve during the clinical trial, can I stay on the treatment when it is over?
Questions about the clinical trial team
- Who is the study physician?
- Who is funding this trial?
- What are the experiences/credentials of the study team?
- Who can I contact during the clinical trial if I have questions or concerns?
Other questions
- Do I need to pay to participate in this clinical trial?
- Do I need to travel for this clinical trial? When? Where? For how long? How often?
- Will I be reimbursed for travel-related costs? If so, what is the reimbursement process?
- If I want to withdraw from the study before it is over, how do I do that?
- Will I learn about the results of the clinical trial? How will the results be shared?
- Is it possible to participate in this clinical trial virtually?
What happens if I decide to leave the clinical trial before it is over?
If you withdraw from the clinical trial, your regular medical team will continue to care for you, and you will receive your routine care. However, if you leave the study due to side effects, you may need treatment for those side effects.
What happens after the clinical trial is over?
When a clinical trial ends, you will continue to receive your routine medical care from your regular medical team.
You may receive treatment for side effects from the clinical trial.
In some cases, you may continue to be followed by the study team for follow-up tests and additional findings.
How do I share information about my clinical trial participation with my medical team?
You should receive a copy of the informed consent form when you enroll in a clinical trial. This form will describe the clinical trial in detail. You can share this information with your medical team, family/friends/loved ones, etc.
How long will it take to know if the clinical trial has helped me?
Most clinical trials include a schedule of tests (for example, CT scans, blood tests, etc.) that will measures the results and/or efficacy of the intervention being tested.
Be sure to ask the study team for more information, including how they will measure the success of the trial.
Is there any way to know which treatment I received?
Typically, you will not know which group you were assigned to until the study is complete, or your participation in the study is complete. However, your group assignment may be identified if medically necessary.
What should I do if I think I’m experiencing long-term side effects from the clinical trial?
Speak with your medical team if you are experiencing long-term side effects
If my condition starts to improve during the clinical trial, can I stay on the treatment when it is over?
This will depend on the clinical trial and the intervention being studied. There are some reasons why you may not be able to receive the intervention after you are finished the clinical trial, including:
- It may not be approved for use in Canada.
- Your medical team may not think it is the best option for you.
- You may determine that it is too expensive if not covered by any other source.
Ask the study team about your options.
What were the results of my clinical trial?
You can ask the study team to inform you of the results of the clinical trial after the trial is complete.
The clinical trial did not give me any benefits. Now what?
Speak with your medical team if you did not experience any benefits from your clinical trial. There may be other options or other clinical trials available to you.
Clinical trial: A clinical trial is a type of research study that tests health-related interventions (such as a new medication) on people.
Clinical trials navigator: Clinical trials navigators are professionals who can help you find a clinical trial, explain the eligibility criteria, and help you decide if joining the clinical trial is right for you.
Control band: A control band is the group of participants in a clinical trial that receives the current standard of care. The other group (the treatment group) receives the new intervention that is being tested, and their outcomes are compared to the control group.
Eligibility criteria: Eligible criteria outline the requirements that must be met for a person to participate in the clinical trial. These criteria might include things like medical conditions, treatment, history. age, sex, and more.
Informed consent: the informed consent process ensures that you are provided with all the information you need to decide if you want to take part. During this process, you should also be given the opportunity to ask questions and discuss with the people in your life.
Phase: Clinical trials are categorized into 4 different phases. In Phase 1, the intervention (for example, a new medication) is being tested on people for the first time. In Phase 2, the intervention is being tested to see if it does what it is intended to do. In Phase 3, the long-term effectiveness of the intervention is tested. In Phase 4, the researchers monitor the intervention after it has been made available on the market and any long-term side effects are measured.
Placebo: Placebos are inactive therapies that look like active therapies (sometimes referred to as “sugar pills”). Placebos are very rarely used in clinical trials for cancer, because the new intervention is instead being compared to the current standard of care.
Protocol: Clinical trial protocols contain extensive information about the clinical trial. For example, the protocol will explain why the trial is being conducted, how it will be done, how the data will be collected and analyzed, how the results of the trial will be shared, and who is involved.
Randomization: Randomization is a process used to compare two or more health-interventions. In randomized trials, participants are randomly assigned (by chance) to receive one of the health-interventions (for example, the new treatment being tested, or the current standard of care).
Research Ethics Board: All research conducted on humans must be reviewed by an independent committee (a research ethics board) to ensure that the safety of the participants is protected and that the methods used in the research study are ethical.
Treatment group: A treatment group is the group of participants in a clinical trial that receives the new intervention being tested (for example, a new medication). The other group (the control group) receives the current standard of care. The outcomes of the treatment group are then compared to the outcomes of the control group.
If you have any questions please contact Alison Ross, Director of Disease Information and Education at 1 877 413-7970 extension 237 or at aross@ovariancanada.org.