Clinical Trials

Today’s Clinical Trials are Tomorrow’s Standards of Care

Clinical trials matter! 

Today's cancer treatments were first developed from clinical trials. Participating in a clinical trial can bring you many benefits, like accessing new drugs and treatments still in the research stage. Participating in a clinical trial can also help advance science and the future of healthcare, helping others and improving cancer treatments.

Cambridge Memorial Hospital has supported our Oncology department’s participation in clinical trials over the past 25 years. We are proud to have been found as a top enrolling Canadian site for the Novartis Bolero 1 Breast cancer study and the second top enrolling Canadian site for the BNIT Prostvac Metastatic Prostate Cancer study.

“Clinical trials in a community hospital makes participation in studies available to patients closer to home,” says Dr. Edmond Chouinard, Medical Oncologist and Head of Clinical Trials at Cambridge Memorial Hospital.  “Participating in a clinical trial can improve quality of care delivery to a patient.”

Enrolling in Clinical Trials

If you are interested in a clinical trial or if your team feels there is a trial that may be right for you, we will arrange an appointment with one of the researchers conducting the trial with your permission.

Sometimes your oncologist may also be the doctor in charge of the trial. You may also meet with a Clinical Trial Research Nurse (CTRN) or Clinical Research Associate (CRA) at one of your scheduled appointments.

Someone from the research team will review the clinical trial with you and answer any questions. They will also review the informed consent form with you. You do not have to agree to participate right away or at all. Please take as much time as you need to think about your decision and discuss your thoughts with others. Another appointment may be booked to talk about the trial further.

If you choose to participate, there are several steps to taking part in clinical trial which will be discussed with you. Our dedicated team will help you through these steps and will become your main contact throughout the trial. You do not have to stay in a trial if you do not wish to.

Informed Consent

Informed consent includes discussing, reading, and understanding the clinical trial. You must sign an informed consent form in order to participate in trial.

Informed consent includes talking about why the trial is being done, who is involved, how long the trial will be, how many patients will be involved, risks and benefits, your legal rights, what you can expect from the trial (screening, tests, your appointments, possible side effects, follow-ups, costs), how the information is collected, how we will protect your privacy, and how you will receive updates about the trial.

By signing the informed consent form, you indicate that you understand all of the information you have been given. You can change your mind at any time for any reason. A copy of the signed consent form is given to you to keep. Once you sign the informed consent form, you will be screened to see if you are eligible for the trial.

Informed consent is a constant process. You are encouraged to ask questions and whenever new information about the clinical trial is known we will share it with you.

It is common that the consent form updates occur throughout a study. If there is a consent update while you are participating in a clinical trial, you will be presented with this updated information to review

Many clinical trials include the collection of blood and tissue samples for medical research. These are called biospecimens. Medical researchers use your samples along with samples from thousands of other patients to look for ways to prevent, find, or treat health problems like cancer, diabetes, heart disease. Many people find comfort knowing that by donating samples, they will help researchers make discoveries that can advance medicine and improve the treatment of others in their community. These samples are usually stored within Canada or the USA. To protect your privacy, your samples will be coded with a random number instead of your name and any identifiers will be removed before the sample is sent to the biobank research facility. Federal law requires the protection of your private medical information.

Screening

Every trial has eligibility criteria which determines who can and cannot participate in a trial. This is to protect your safety. You may be asked to undergo certain tests, procedures, or blood work to determine if this trial is right for you.

Treatment and Interventions

Your research team will follow strict rules outlined in the clinical trial protocol when giving the trial treatments or interventions. There are many types of clinical trials.

In clinical trials that use an intervention, such as testing different cancer scanning techniques, the goal is usually to prevent cancer, detect cancer earlier, or improve symptoms. Other clinical trials may test different treatments. The goal of treatment is to get rid of, stop, slow, or reduce the growth of your cancer.

In treatment trials, your research team will watch you and your cancer closely to see if the treatment is working and to manage any side effects. In some trials, there is a prescribed number or amount of treatment given; in others, you may stay on the treatment as long as it is benefitting you. If the treatment does not seem to be working for you, meaning your cancer is growing, the trial treatment will be stopped and other treatment options will be discussed with you.

Treatment can be stopped for various reasons, such as if your cancer does not respond to treatment, or you are having side effects that cannot be easily managed, or if it is no longer in your best interest to be on that particular treatment (such as if there’s a better treatment available for you). You can choose to stop participating in a trial at any time as well.

When the trial treatment or intervention is completed or stopped, you enter the follow-up stage of the clinical trial. You may be asked to complete tests, procedures, bloodwork, or assessments in order to measure the trial.

Follow-Up

After you are finished in the trial, you may be asked for further tests or assessments. Follow-up may be done by appointment, over the phone, or even by looking at your medical records (which may not require any action on your part).

Once all patients have had their follow-up completed, the study results are analyzed.

Final Study Results

Most trials will look at their data during the study itself, called an “interim analysis”. This helps determine if the trial is working, and if so the trial will continue.

At the end of the trial, the final results are reviewed, analyzed, presented, and published. As a participant, you may also be given the results of the study. If the new treatment is proven safe and effective, further testing may occur or Health Canada may review and approve the treatment for wider use.

Clinical trials are constantly changing the standard of care to bring new and better treatments to the forefront.

Ethics

All clinical trials need ethics approval. This is to protect the health, safety, and privacy of everyone who participates in the trial. Trials at Cambridge Memorial Hospital are approved by either our local regional Tri-Hospital Research Ethics Boards (THREB) or by the Ontario Clinical Trial Research Ethics Boards (OCREB).

Success Stories

We have been involved in Clinical Trials for over 25 years. Our top accomplishments include:

  • Top enrolling Canadian site for the Novartis Bolero 1 Breast Cancer study
  • Second top enrolling Canadian site for the BNIT Prostvac Metastatic Prostate Cancer study

 

 

Links to Additional Information

These National resources offer reliable information about clinical trials that are open to recruitment:

  • Ontario Cancer Research Ethics Board (OCREB)
    OCREB Logo
    OCREB works with researchers, institutions, and sponsors to protect the rights and welfare of trial participants in Ontario while advancing ethically sound cancer research.

  • Canadian Cancer Trials
    Canadian Partnership Against Cancer Logo - Canadian Cancer Trials
    Clinical trials in all Canadian provinces.

  • Canadian Clinical Trials Group
    Canadian Cancer Trials Group Logo
    The Canadian Cancer Trials Group is a cancer research cooperative group that designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. Primary support for the Canadian Cancer Trials Group comes from the Canadian Cancer Society.

  • Canadian Cancer Society
    Canadian Cancer Society Logo
    Access online or call toll-free 1-888-939-3333

  • It Starts with Me
    It Starts With Me Logo
    A website about clinical trials developed by patients and caregivers who have participated in a clinical trial or have had a loved one participate in a clinical trial and by people who work in clinical trials and research. The website tells you everything you need to know about clinical trials, things to think about or ask before you decide to participate, and your rights as a person who is volunteering in a clinical trial. There is also a glossary of terms for you. The site was created by the Network of Networks (N2) - an organization that represents organizations that do clinical research and trials in Canada

  • The National Cancer Institute
    National Cancer Institute Logo
    Provides accurate up-to-date information about many types of cancer, clinical trials, information for researchers and health professionals, and resources for people dealing with cancer

  • U.S. National Library of Medicine: Clinical Trials
    US National Library of Medicine Logo
    Provide patient, families, and the public with easy and free access to information about clinical trials for a wide range of conditions and diseases