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The medical community has a responsibility not only to provide the best available care, but also to develop new and better methods of care. Advances come from new ideas or approaches, which may originate with a scientist in a laboratory or a caregiver at the bedside. However, before new therapies may be offered widely, they must first be tested to ensure they are effective and safe.
Clinical research is the term used to broadly describe any research project/study involving humans or their health data, carried out to increase medical knowledge. Prevention, diagnosis, treatment and conditions or diseases may be examined. The research may be an “observational study” or a “clinical trial.”
Observational studies do not involve adding an intervention or treatment to one’s care. This type of study may collect data to compare two accepted treatments, require additional diagnostic tests or collection of blood samples for testing in the laboratory, but it will not alter a participant’s routine care.
Clinical trials are defined by the World Health Organization as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Clinical trials determine if a new treatment or therapy is beneficial. Studies may examine new drugs, medical devices, diagnostic imaging techniques, procedures or behaviour modification. Carefully conducted clinical trials examine specific health outcomes to inform health professionals how well the treatment works, provide safety data, and in some cases, may provide patients with access to new therapies not yet available for general use. Results of clinical trials influence care, and have shown the effectiveness of life saving treatments such as insulin, chemotherapy, renal dialysis, cardiac angiograms, stents, bypass and valve surgery and organ transplantation.
There are many types of clinical trials, such as:
- comparing the current treatment (often called the ‘standard of care’) against a new treatment or procedure which is hoped to provide better results;
- using a drug or device for a new indication;
- providing a new drug with comparison to an inactive pill, called a placebo;
- comparing two known and approved treatments or interventions by randomly assigning individuals to a specific treatment; or
- simply comparing a treatment or intervention against no treatment or intervention.
Most clinical trials involve a process called randomization. Randomly allocating participants into one intervention group or another, like the toss of a coin or pulling numbers from a hat, ensures there is no bias or influence on the study outcomes. Most randomized trials are also conducted in a “blinded” manner, meaning that the participant does not know which treatment is being provided. If the study is “double-blind,” the treating physician is also not aware of the treatment allocation. Again, this is done to minimize bias or prejudices and strengthen the validity of the final results of the study.
Funding for these trials may come from industry sponsors (pharmaceutical, device, or technology companies, etc.), government (e.g., granting agencies such as the Canadian Institutes of Health Research (CIHR)) or the Heart and Stroke Foundation of Canada (HSFC), or from the institution. Administrative support for research endeavours is provided by the Ottawa Heart Institute Research Corporation (OHIRC), the research and contracts arm of the UOHI, and the UOHI Office of Research Services.
We strive to involve patients or their close family members in discussions that influence the course of clinical research. Patient engagement provides an opportunity for meaningful input into the priority setting and conduct of research, from those with firsthand experience! For patient-related support, please see the Patient Alumni site.
Clinical Research Team
Clinical trials are normally conducted by a team of researchers, also called Investigators. The lead investigator is referred to as the Principal Investigator (PI) and is ultimately responsible for the trial conduct. Investigators may be scientists, nurses, physiotherapists or other allied healthcare professionals, and most commonly at the Heart Institute, they are medical doctors.
Clinical research coordinators (CRC) or research assistants (RA), are typically responsible for the day-to-day management of the study under the supervision of the PI. CRCs and RAs generally have a strong health science background, many working in direct patient care with some being nurses. CRCs and RAs are very knowledgeable about the study, stay in close contact with study participants, and are available to answer participants’ questions. Often the team also includes students, residents, fellows and/or support staff. Of course, the research activity is also assisted by the exceptional clinical staff who are directly involved in patient care.
Clinical Research Oversight
Plans for the conduct of a study must be clearly detailed in a study protocol. This protocol is the “rule book” for the study, explaining who is eligible to participate in the trial, the treatment(s) to be used, the diagnostic tests or procedures to be done, blood samples to be drawn, the schedule of assessments and the data to be collected, etc.
The protocol must be reviewed and approved by an independent body of experts, called a Research Ethics Board (REB) (also known as an Independent Research Board/IRB) before the study is permitted to begin. The REB is responsible for the ethical oversight of the research, ensuring the study complies with strict regulations designed to protect the rights and well-being of research participants. If the clinical trial involves use of an investigational product, there must also be authorization from Health Canada to conduct the study. In addition, if a trial has been awarded funds through a granting agency, such as the Heart and Stroke Foundation, the study protocol was reviewed by a panel of scientific and medical experts in the field and determined to be scientifically sound and of significant importance.
The Principal Investigator conducting the study at the UOHI is ultimately responsible for the conduct of the trial and the safety of the participants, but as explained above, he or she is generally supported by a team of staff and/or students. Finally, the UOHI has an internal auditor who conducts random audits of clinical research study activity, to provide ongoing oversight and education to PIs and research teams.
Agreeing to participate in a research study is completed through an informed consent process. The study is explained in detail by research staff, with an opportunity for questions. The Informed Consent Form (ICF) is the most common tool to obtain informed consent. This document, approved by the REB, contains the necessary details of the study, including such topics as: the purpose of the study, the treatment/ product being evaluated, the benefits and risks, alternatives to participation, and a plan to protect confidential information. By signing the form participants agree to volunteer for the study, but this is not a binding contract; participants may withdraw at any time. Volunteering in a study is an important personal decision. Participants are encouraged to discuss the options with their healthcare providers, family and friends before making a decision.
Benefits and Risks
There must be a favourable balance between benefit and risk for a clinical research study to proceed. The safety and well-being of participants is considered carefully.
In many cases there is no direct benefit to participants, but participation will provide medical knowledge that may benefit future patients. However, experimental treatments, accessed for evaluation in a study before they are approved for general use, may sometimes provide a direct benefit to participants. Clinical trials typically require close monitoring by the healthcare team, with frequent contact, which may be comforting and helpful to participants.
Since clinical trials are often testing new experimental or investigational products, the risks may not be known, or not fully understood. The new treatment may not be effective or in some cases, there is a possibility of unpleasant, serious or even life-threatening unwanted effects - however, participants are monitored closely for any untoward effects. Study participation may result in additional time commitments, more tests or visits to the hospital.
UOHI requires expressed permission before Investigators or research staff may contact patients for research purposes. If you are a patient at the Heart Institute, please note:
- Institute healthcare staff will ask for your permission for researchers to contact you.
- Agreeing to be contacted does NOT mean you are agreeing to participate in a study; it just permits the researchers to contact you.
- Deciding not to grant permission will NOT affect the care you receive.
- If you have provided permission, researchers may contact you to discuss your potential for participation in a study.
- Research participation is completely voluntary!
The best patient care is supported with vibrant research and education. In the end we depend on volunteers to participate in our studies, to enable us to advance medical care. Please take the time to read the Facts and Questions (pdf) sheet.
If you are interested in volunteering for a research study, please refer to the list of clinical trials ongoing at the University of Ottawa Heart Institute (UOHI)/Ottawa Heart Institute Research Corporation (OHIRC), by visiting the Clinical Trials page. The list can be sorted to show those studies which are recruiting participants. Please note that there may be other research studies recruiting participants which are not included in this list, so if interested, please follow up with your healthcare professional JoinAStudy@Ottawaheart.ca.
- It Starts With Me: 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.
- Canadian Institutes of Health Research (CIHR)
- CIHR Health Research Jargon Buster
- CIHR - Strategy for Patient-Oriented Research
- Heart and Stroke Foundation, Ontario
- The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2 - 2014)