Clinical Research
Clinical research is a branch of medical research that involves people who have volunteered to participate, and which aims to determine the safety and effectiveness of the most promising advances in patient care (e.g., medications, devices, tools, technologies, diagnostic tests, treatment regimens).
The two main kinds of clinical research include:
- Observational studies – aim to identify and analyze patterns in medical data or biologic samples provided by study participants
- Clinical trials (also known as interventional studies) – test the safety and effectiveness of medical interventions in living people
Within these kinds of research, there are many types of studies. These can include:
- Studies on human biospecimens e.g., research on biological materials stored in a tissue bank
- Healthy volunteer studies e.g., studies on how a new drug affects the body
- Surveys, interviews, focus groups e.g., studies on health behaviors, practices and opinions
Clinical Trials
A clinical trial is a type of research study that tests health interventions on people (for example, a new medication), providing extremely valuable learnings for medical advancement.
Clinical trials help connect individuals with new and emerging treatments while ensuring utmost safety and as little risk as possible to participants.
Clinical trials answer important questions, such as: “Does this new medication improve outcomes?”, “Are there side effects and how manageable are they?”, and “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.
Clinical trials resources
Resource guide
Clinical trial FAQ: The basics
Learn the basics of clinical trials such as what they are, how they are run, all about placebos, and more.
Resource guide
Clinical trial FAQ: Finding a clinical trial
Discover how to find a clinical trial, get resources to help, and see what to do if you can't find one.
Resource guide
Clinical trial FAQ: Is a clinical trial right for you?
Explore questions you can ask yourself and the clinical trial team when deciding if a clinical trial is right for you.
Resource guide
Clinical trial FAQ: Participating in a clinical trial
Learn about participating in a clinical trial, its success, side effects, and follow up.
Resource guide
Talking to your doctor about: Clinical trials
Need some guidance on discussing clinical trials with your doctor? Here is a reference tool you can use at your next appointment.
RELEVANT CLINICAL RESEARCH STUDIES CURRENTLY RECRUITING PARTICIPANTS
Ovarian Cancer Canada is committed to driving research forward, and therefore shares relevant research opportunities with those affected by ovarian cancer, where appropriate.
Not all studies listed below are funded by OCC, but: 1) are open to Canadian participants, 2) have obtained Research Ethics Board approval, and 3) have been deemed relevant to the ovarian cancer community by OCC staff.
Study leads:
Drs. Trevor Pugh, Raymond Kim and Yvonne Bombard (Toronto, ON)
Brief summary:
CHARM is a research initiative that collects longitudinal plasma samples, tumour tissue, genomic/epigenomic data, and clinical data on individuals with a hereditary cancer syndrome, regardless of personal cancer history.
The purpose of CHARM2 is to evaluate the performance of a blood test for early cancer detection. Recruitment is currently open at the University Health Network in Toronto, with more sites to be open across Canada.
To learn more and/or participate go to:
Brochure: CHARM2 Brochure
You can also email us at charm-research-study@uhn.ca
HELP MAKE GENETIC SERVICES & RESEARCH MORE EQUITABLE
Study lead:
Dr. Yvonne Bombard (St. Michael’s Unity Health Toronto)
Brief summary:
We are looking for adults (18+) who identify as a person of colour and have used or tried to use cancer genetic services in Ontario, Canada to take part in a 30-60 min research interview via Zoom or telephone. Participants will receive a gift card as a thank you.
To learn more and/or participate email:
Study lead:
Dr. Stephanie Lheureux (University Health Network / University of Toronto)
Brief summary:
This OCC-funded clinical trial is looking at how using detailed cancer information at the molecular level can help direct treatment when cancer has returned; an approach that is unique and specific to each patient and her disease.
Launched across Canada’s leading cancer centres, the Re-VOLVE clinical trial will enroll women whose cancer has returned after treatment with PARP inhibitors.
To learn more and/or participate go to:
Clinicaltrials.gov link: NCT05065021
Study leads:
Dr. Diane Provencher (CHUM) and Dr. Helen MacKay (Sunnybrook Health Sciences Centre)
Brief summary:
This OCC-funded clinical trial aims to enroll 30 patients with confirmed relapsed platinum-resistant or intermediately sensitive high-grade serous ovarian cancer, to assess the safety and efficacy of combining Veliparib (a PARP inhibitor) with Navitoclax, another drug.
To learn more and/or participate go to:
Clinicaltrials.gov link: NCT05358639
Study lead:
Dr. Amit Oza (University Health Network / University of Toronto)
Brief summary:
This OCC-funded clinical trial is testing a new drug, called CX5461, that may help kill cancer cells should it return after treatment with a PARP inhibitor.
Research to date has shown that this drug successfully kills cancer cells by blocking major components of the machinery needed to successfully complete DNA repair.
To learn more and/or participate go to:
Clinicaltrials.gov link: NCT04890613
Study lead:
Dr. Laura Hopkins (University of Saskatchewan)
Brief summary:
This OCC-funded pragmatic clinical trial is currently open to ovarian cancer patients in Saskatoon and Nova Scotia.
In this trial all women with high-grade serous ovarian cancer will have a special molecular test (called HRD testing) performed on their tumour sample. Patients whose tumours are found to be homologous recombination proficient (HRP) will be provided with a decision aid to help them decide whether to pursue treatment with a PARP inhibitor.
To learn more go to:
Tumour testing and ovarian cancer drug prediction program Research Showcase
HEREDITARY CANCER SYNDROME INDIRECT IMPACT STUDY
Study lead:
Dr. Yvonne Bombard (St. Michael’s Unity Health Toronto)
Brief summary:
The purpose of this study is to assess the indirect impacts of hereditary cancer care to the patient across different provinces with varying care systems, populations, and genomic testing technologies. We will be using a survey to understand the indirect burdens of living with a hereditary cancer.
We are looking for adults (18+) with a diagnosis of a hereditary cancer syndrome who receive care in Canada to take a 30 minute anonymous survey.
To learn more and/or participate go to:
Connect with us
If you have questions or would like more information and support, please contact Alison Ross, Director, Knowledge Mobilization at aross@ovariancanada.org or at 1-877-413-7970 ext. 237.
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 categorised 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 analysed, how the results of the trial will be shared, and who is involved.
Randomization: Randomisation is a process used to compare two or more health-interventions. In randomised 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.
American Society of Clinical Oncology. (2022). Patient safety in clinical trials. Retrieved: https://www.cancer.net/research-and-advocacy/clinical-trials/patient-safety-clinical-trials
Clinical Trials Ontario. (2022). Learn more about clinical trials. Retrieved: https://www.ctontario.ca/patients-public/learn-more-about-clinical-trials/
Government of Canada. (2020). Clinical trials and drug safety. Retrieved: https://www.canada.ca/en/health-canada/services/clinical-trials.html
Government of Canada. (2022). Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”. Retrieved: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100.html
John Hopkins Medicne. (2024). Clinical Research: What is it?. Retreived: https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-what-is-it