Clinical trials - Bladder Cancer Canada

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CLINICAL TRIALS

In addition to the therapies approved by Health Canada, patients may be able to access other bladder cancer therapies through a clinical trial.

A clinical trial is a research study that tests how well a new medical approach works in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease such as bladder cancer. By participating in a clinical trial, you will be helping researchers answer important questions that will further the development of new effective treatments. Clinical trials may also provide you with another option in your treatment plan.

As a patient, you may be eligible to access a clinical trial, depending upon your type of bladder cancer, the stage of your disease and whether or not you have had prior therapies. If you find a clinical trial that may be of interest to you, take the information to your physician to discuss it in more detail.

WHAT ARE THE PHASES OF CLINICAL TRIALS?

There are 4 types of clinical trials that are most often conducted when studying investigational drugs:

PHASE 1

Phase 1 trials are the first step in testing an investigational drug in people and are often the first time a drug is given to humans. In these studies, researchers evaluate side effects of the drug, what dose is safe, how the drug should be given (by mouth, injected into a vein, or injected into the muscle), and how often the drug should be administered/taken. Phase I trials usually enrol a small number of participants.

PHASE 2

Phase 2 trials study the safety and effectiveness of an investigational drug and evaluate how it affects the human body. Phase 2 studies usually focus on a particular type of cancer.

PHASE 3

Phase 3 trials continue to study the safety and effectiveness of an investigational drug. These studies often compare an investigational drug with the current standard therapy. In most cases, studies move into Phase 3 testing only after they have shown promise in Phases 1 and 2. Phase 3 trials often include large numbers of participants across the country.

PHASE 4

Phase 4 trials are conducted to further evaluate the long-term safety and effectiveness of a drug. They usually take place after the drug has been approved for standard use. Several hundred to several thousand people may take part in a Phase 4 study.

SHOULD YOU JOIN A CLINICAL TRIAL?

There may be risks to participation in a clinical trial. Every clinical trial has been reviewed by an independent ethics board. This board ensures that risks of participating are within reason and seen as similar to the regular treatment that patients receive. The Tom Baker Cancer Centre in Calgary lists the following benefits and risks of joining a clinical trial:

Potential Benefits

1. Clinical trials allow participants to play an active role in their own health care treatment choices.

2. Participants gain access to new treatments before they are available to the public.

3. Study treatments may give an additional treatment option that does not otherwise exist.

4. Experimental treatments may prove to be a more effective treatment than the current standard treatment.

5. Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.

6. Some participants view increased tests and follow-up as a benefit.

7. Participants help others by contributing to medical research.

POTENTIAL RISKS

1. Some of the trials may be very early in treatment development. Therefore the risks may not be known yet.

2. New drugs/treatments may have side effects or risks that doctors do not expect or that are worse than those resulting from standard care.

3. If the study involves more than one type of drug/treatment participants may not be able to choose which drug/treatment they receive.

4. Experimental treatment may not be effective.

5. The study treatment may require more time involvement. Actual visits to clinics tend to take longer due to study requirements.

6. Be aware that studies can involve considerable out-of-pocket expenses for you such as travel parking and missed days at work.

INFORMED CONSENT

A critical part of any study is the “Informed Consent” document which you will read and sign before beginning the trial. This document (likely accompanied by an interview) will explain the purpose of the research, spell out what will be done to you, and explain the benefits, risks and discomforts you may experience. The document will help you decide if you want to participate in the trial and will provide a solid foundation for the interaction between you and the researchers.

FINDING A CLINICAL TRIAL

To assist you in finding a clinical trial that may be available in your area, check these websites:

CLINICALTRIALS.GOV

ClinicalTrials.gov is a registry and results database maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). The site contains information about publicly and privately supported clinical studies of human participants conducted around the world, which can by searched by location.

VISIT SITE

CANADIANCANCERTRIALS.CA

This site is managed by the Canadian Partnership Against Cancer corporation; an independent organization funded by the federal government to accelerate action on cancer control. The database includes Canadian trials only. You can narrow your search by selecting bladder cancer under “Select a Cancer Type,” and by searching by province, city or trial centre.

VISIT SITE

HEALTH CANADA’S CLINICAL TRIALS DATABASE

This database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. Patients can access the database to determine if a clinical trial has met the regulatory requirements. The database may also assist Canadians in finding clinical trials that might be relevant to their medical condition.

VISIT SITE

CANCER RESEARCH INSTITUTE’S CLINICAL TRIAL FINDER

The Cancer Research Institute’s Clinical Trial Finder is designed to help patients quickly search for clinical trials that match their specific cancer diagnosis and treatment history. This database features studies using immunology along with the full national database of cancer treatment trials from all sponsors in North America. Fill out a questionnaire to identify clinical trials looking for your specific diagnosis, stage and treatment history. You can also request a call from a Clinical Trial Navigator.

VISIT SITE

ONCOQUEBEC SEARCH ENGINE

OncoQuébec, a search engine to find oncology clinical trials. It was launched by Q-CROC. OncoQuébec allows you to search by keywords (e.g. bladder cancer) or categories (e.g. hospital). Although it was developed for health professionals, its use is intuitive enough to meet the needs of people with cancer and their loved ones.

VISIT SITE

Trials listed on each of these websites may vary, so we recommend that you check each one. Keep in mind that not all available trials may be listed, therefore it is always worthwhile to ask your physicianto recommend any trials which you may qualify and benefit from.

Remember, many patients will not be eligible to participate in studies. Even though you may feel that you qualify, researchers will have very specific requirements for who can participate in their trial.

If you are currently on or have been on a clinical trial in the past, we urge you to get in touch with Bladder Cancer Canada. Feedback on your experience with new treatments is important to us so that we may provide patient input to the bodies that approve drugs in Canada (if the trial involves a drug).

Learn more about the drug approval process in Canada and why patient input is critical.

IMPORTANT!

Information on this page is intended to be used for general information only and should not replace consultation with health-care professionals. Consult a qualified health-care professional before making medical decisions or if you have questions about your individual medical situation.

WHAT ARE THE PHASES OF CLINICAL TRIALS?

PHASE 1

PHASE 2

PHASE 3

PHASE 4

SHOULD YOU JOIN A CLINICAL TRIAL?

Potential Benefits

POTENTIAL RISKS

INFORMED CONSENT

FINDING A CLINICAL TRIAL

IMPORTANT!

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