Clinical Trials and Research

Research and Clinical Trials for Improved Healthcare

Research plays an extremely important part in healthcare at the Thunder Bay Regional Health Sciences Centre. As an academic health sciences centre, we are literally a centre for learning for researchers, students, teachers, and other healthcare professionals.

But that’s not why we do it. We emphasize research and training at the Health Sciences Centre because it leads to better patient care, today as well as tomorrow. We’ve attracted researchers from around the world to Thunder Bay to work at the Health Sciences Centre and/or the Thunder Bay Regional Health Research Institute (TBRHRI), the research arm of the Health Sciences Centre (find out more at www.tbrri.com). Together, we’re partnering with other world-class researchers at Lakehead University, the Northern Ontario School of Medicine, and others, developing tomorrow’s healthcare techniques and equipment right now.

In turn, we’ve attracted some of the best physicians and other healthcare providers who want to work in our academic environment. Every year, we’re drawing students to Northwestern Ontario who want to train here, making them more likely to stay and practice here too.

Clinical Trials

Clinical trials in particular have a positive impact on patient care, and are an important part of any research program. Clinical trials are research studies investigating new treatment methods, medications, equipment, and/or medical conditions themselves to improve care for future patients.

What to Expect

Based on the current availability of clinical trials patients will be asked if they would like to participate in a clinical trial when they are admitted to the Thunder Bay Regional Health Sciences Centre. Alternatively, it may also be suggested to you by your primary care provider or specialist, or you may also actively search out a clinical trial on your own. No matter how you learn about these research studies, it’s important to note that you have the right to refuse any clinical trial. Also, clinical trials have a screening process to ensure patients meet certain criteria or conditions, so you may not be accepted into a clinical trial in any case. Common criteria include age, sex, type of medical condition, existence of other medical conditions, and current treatment plans.

Once you have indicated that you are open to participating in a clinical trial, a member of the research team at the Health Sciences Centre will review your chart to see if you are a good match for an ongoing trial.

An important part of the clinical trials process is your informed consent, and you will have to sign a form for that clinical trial to officially join the study. A member of the research team will go over all the risks and benefits of participating in the study with you (some general risks and benefits are outlined below). This is also an opportunity for you to ask some of your own questions, including:

  • Who is conducting the study (lead investigator and study sponsor)?
  • What is the goal of the clinical trial?
  • If I choose not to join the clinical trial, what would my treatment options be?
  • What will I have to do during the clinical trial?
  • How long is the study, and how much time/extra tests will I be expected to give?
  • Can I leave the clinical trial if I want to?
  • Do I have to pay anything, and if so, am I reimbursed for my expenses?
  • What rights do I have as a participant?

If you decide to join the trial, a member of the research team will describe the next steps with you, which vary depending on the study. For example, if the study is comparing two drugs, or the effects on patients with or without the drug, you will be randomly assigned a spot in the test group or control group (see Glossary, below). After that, you simply have to follow the directions given to you and attend any appointments made for you. You will have the opportunity to contact the Clinical Trials office anytime with questions you may have.

There are dozens of clinical trials underway at the Health Sciences Centre at any given moment. You can find a list of open clinical trials here.

Patients who enrol in a clinical trial may benefit directly as well, as you’ll read below. However, you will not be paid for joining a clinical trial except for the possible reimbursement of any expenses associated with the clinical trial.

Potential Benefits and Risks

Clinical trials have their own set of benefits and risks. A member of the research team and/or members from your own healthcare team will explain the specific benefits and risks of the clinical trial you are considering joining. Here are some general things to think about:

Possible Benefits for You

  • You may receive direct health benefits
  • You will be able to talk to a member of the research team about any questions you have about your treatment or the study, giving you another resource
  • You may receive additional monitoring of your health as part of the trial
  • People in clinical trials tend to become more involved in their care, and people more involved in their care tend to have better outcomes

Possible Benefits for Your Family and Others

  • Research helps find better treatments. At the TBRRI, research is focused on meeting the healthcare needs of Northwestern Ontario.
  • In the case of genetic diseases, research today could directly impact your children and grandchildren tomorrow
  • Clinical trials going on right now in Thunder Bay may lead to new treatments for patients around the world
  • Many researchers also take positions at Lakehead University and/or the Northern Ontario School of Medicine, training the next generation of healthcare professionals

Possible Economic Benefits of Research for the Community

  • Research opportunities attracts scientists who in turn attract assistants, students, and other staff
  • These new researchers buy houses and contribute to the local economy
  • Researchers often need specialty services provided by local businesses
  • New research leads to business startups in the city, like XLV Diagnostics launched in 2011
  • Researchers bring more research dollars to the city

Potential Risks

Your health always comes first. We do everything to ensure you get the best care possible during your participation in any clinical trial. However, there are some drawbacks to joining a clinical trial that you should consider as well:

  • No guarantees of health benefits
  • You will not know whether you are in the test group or the control group
  • Even if health benefits are demonstrated for some participants, it may not work for you
  • Potentially more tests
  • If so, more time travelling and preparing for tests
  • In some cases, you will be asked to follow strict dietary, supplement, and/or exercise routines, and may be asked to avoid certain activities and/or foods and drinks
  • Participation in one clinical trial may make you ineligible for another clinical trial
  • Possible side effects (these will be discussed in full before you decide to join a clinical trial)

Every clinical trial, whether it is developed here in Thunder Bay or is part of a larger national or international trial, is carefully reviewed by our Research Ethics Board to ensure that it is safe, offers potential benefit to patients, and is conducted in an ethical matter. For more information, please contact the Research Ethics Office directly at REO@tbh.net or (807) 684-6422.

Participating in a clinical trial is always voluntary, and you should never feel pressured to join any clinical trial. After you find out the information about the trial and consider your options, it is totally acceptable to say no.

How to Sign Up

For more information about clinical trials including how to sign up, please contact the Clinical Research Program at (807) 684-6608. We will discuss what possible clinical trials may be available, go over the application information (often different for each trial), and answer any general questions you may have. You can also find a list of most current clinical trials at the Health Sciences Centre here: http://clinicaltrials.gov/ct2/results?term=Thunder+Bay&recr=Open

(Note: some programs at the Health Sciences Centre are directly enrolled in certain clinical trials. Ask you specialist for more information.)

Most clinical trials have certain criteria that must be met before a patient can be enrolled into a clinical trial. Meeting these criteria is important for several reasons, including for the safety of the patient. We carefully screen all patients who apply for a clinical trial.

Glossary of Terms

Here are some common terms used for clinical trials. You can also ask a member of the research team if you have any questions at (807) 684-6608.

Clinical Trial – Research studies investigating new treatment methods, medications, equipment, and/or medical conditions themselves to test their effectiveness and/or safety, and ultimately to improve patient care.

Principal Investigator – The lead researcher/investigator of the clinical trial. Note that, especially in larger trials, there may be several investigators.

Sponsor – The organization or entity paying for the study. This may be a private company like a pharmaceutical company, a government agency or department, a university, a hospital, the Health Sciences Centre, the Thunder Bay Regional Research Institute, or a combination of the above.

Test Group – In a trial comparing a drug or treatment vs. no treatment (placebo), people in the test group are the ones receiving the treatment being tested. In most cases, especially those involving drugs, you will not know whether or not you are in the test group. You do not get to choose which group you are in.

Control Group or Placebo Group – In a trial comparing a drug or treatment vs. no treatment (placebo), people in the control group are the ones not receiving the treatment being tested. This group is still vitally important to the study since it allows researchers to compare the two groups to measure the effectiveness of the treatment being tested. In most cases, especially those involving drugs, you will not know whether or not you are in the test group. You do not get to choose which group you are in.

Informed Consent – The investigators of a clinical trial – and by extension, the staff at the Clinical Trials office – must ensure that you completely understand what the test is for, and that you understand the potential benefits and risks. Do not sign the Informed Consent form until you are comfortable that you know everything you need to know about the study and its possible effects on you and your health.

Industry Partners

The Health Sciences Centre and the TBRRI work closely with industry partners. There are many benefits:

  • Allows the Clinical Research Program to be self-sufficient – doesn’t use patient care funding
  • Allows new and effective treatment options to get to the patients who need them faster
  • Brings in specialists, expertise, and equipment that wouldn’t otherwise be available
  • Underlines our credibility as a world-class research site

With a strong clinical trials infrastructure in place since the 1980s and our unique research opportunities, we continue to attract industry partners from around the world.

Administrative Contact:

Daniel Horne
Manager, Clinical Trials Services Department
horned@tbh.net