Frequently Asked Questions
What is a clinical trial?
A clinical trial is a research study involving patients and volunteers enabling us to answer specific questions related to healthcare. Carefully conducted clinical trials are the quickest and safest way to discover new and effective treatments and therapies.
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior. Clinical trials may compare a new dental approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.
Interventional trials determine whether experimental treatments are safe and effective under controlled environments. Observational trials, however, address health issues in large groups of people or populations in natural settings.
What are the reasons for conducting clinical trials?
Clinical trials are designed to add to knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical trials include:
- Evaluating one or more interventions (for example, drugs, dental devices, approaches to surgery ) for treating a dental disease, syndrome, or condition .
- Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
- Examining methods for identifying a condition or risk factors for that condition
- Exploring and measuring ways to improve the comfort and quality of life of people with dental disease.
Who conducts clinical trials?
Every clinical study is led by a principal investigator, who is often a dentist. Clinical studies may also have a research team that may include dentists, dental assistants, clinical trial managers and clinical trial coordinators.Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic centers, voluntary groups, and other organizations, in addition to federal and provincial agencies. Dentists, dental supply companies, and other individuals can also sponsor clinical research.
Where are clinical trials conducted?
Clinical trials can take place in many locations, including hospitals, universities, dentists' offices, and community clinics. The location depends on who is conducting the study.
How can a patient or volunteer benefit by participating in a clinical trial?
Participants who are involved in clinical trials can play a more active role in their own healthcare and gain access to new research treatments before they are widely available. Our volunteers and patients help others by contributing to research.
Who is eligible to participate in a clinical trial?
All clinical trials have guidelines specifying who is eligible to participate. ‘Inclusion’ and ‘exclusion’ criteria are an important principle in research that enables us to produce reliable results. The factors that determine eligibility are called “inclusion criteria,” whereas the factors that determine non-eligibility are referred to as “exclusion criteria.” The decision is based on factors such as age, gender, one’s type and stage of a disease, previous treatment history and other medical conditions.
Before joining a clinical trial a participant must qualify for the study. Some research studies seek participants with specific illnesses or conditions, while others simply need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead the criteria are used to identify appropriate participants that will enable safe and accurate research results.
What events take place during a clinical trial?
The clinical trial process depends on the type of research being conducted. The clinical trial team includes dentists, dental assistants, clinical trial managers and clinical trial coordinators.. They check the health of the participant at the beginning of the trial, give specific instructions for participating during the trial, monitor the participant carefully throughout and stay in touch after completion. Some clinical trials involve more thorough tests and dentists’s visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What is meant by “informed consent?”
“Informed consent” is the preliminary process in which a volunteer or patient learns about a clinical trial before deciding whether or not to participate. Upon our first consultation, dentists and staff involved in the trial explain the details of study helping the participant to decide whether or not to engage.
The research team then provides an “informed consent” document that includes details about the study such as its purpose, duration, required procedures, key contacts, statements of risks and benefits. The participant then decides whether or not to sign. It is important to note that the document it is not a formal contract and therefore the participant may withdraw from the trial at any time.
What are the benefits of participating in a clinical trial?
Good research design attempts to maximize benefits and minimize risks. By carefully designing, executing and supervising trials, researchers try to reduce those risks. Participants van benefit by:
- Playing an active role in their own dental health.
- Gaining access to new research treatments before they are widely available.
- Obtaining expert dental care at leading health care facilities during the trial.
- Contributing to dental research.
What are the risks of participating in a clinical trial?
The potential risks include:
- Ineffective treatment
- Extended time and attention including more trips to the study site
- More treatments, hospital stays or complex dosage requirements
- Possible unpleasant, serious or even life-threatening side effects
Our team will educate the participant on all of the potential benefits and risks involved, ensuring safety and reliability throughout the entire process.
How is safety of participants ensured?
Most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol: a plan that outlines what researchers will do throughout the study. As a clinical trial progresses researchers report the results of the trial at scientific meetings, to dental journals and to various government agencies. The names of individual participants will remain confidential and will not be disclosed in these reports.
What are some important questions a participant should ask in preparation for a trial?
Participants must learn as much as possible about the clinical trial prior to commencement. They should feel comfortable asking members of the research team any questions that come to mind. As a start the following questions might be helpful for the participant to consider. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be participating in the study?
- Why do researchers believe that the experimental treatment being tested might be effective?
- Has my particular treatment been tested before?
- What tests and experimental treatments are involved?
- How do the possible risks, side effects and benefits of the study compare to those prevalent in my current treatment?
- How might this trial impact my daily life?
- How long will the trial last?
- Will I be required to be hospitalized?
- Who is responsible to cover the financial cost of the experimental treatment?
- What expenses are subject to reimbursement?
- What type of long-term follow-up care is required for this study?
- How will I know that the experimental treatment is working?
- Will results of the trials be provided to me?
- Who will be taking responsibility for of my care?
Every clinical trial in Canada must be approved and monitored by an Institutional Review Board (IRB) or Ethics Review Board (ERB) to make sure the potential benefits outweigh the anticipated risk. An IRB is an independent committee of physicians,dentists, statisticians, community advocates and other healthcare professionals ensuring that a clinical trial is ethical and protects the safety of the participant. All institutions that conduct or support biomedical research involving people must by federal regulation have an IRB approval and be subject to regular reviews.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial the participant should inform the research team and convey reasons for departure.
Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory , the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial more and more information is gained about an experimental treatment, its risks and its effectiveness.
What is referred to as a ‘protocol’?
A protocol is a document that describes the objective(s), design and the procedures involved in a clinical trial. The protocol usually also gives the background and rationale for the trial. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial participants following a protocol are seen regularly by the research staff to monitor their dental health and to determine the safety and effectiveness of their treatment.
What is referred to as a ‘placebo’?
A placebo is an inactive pill, liquid or powder that has no treatment value. It is a simulated treatment for a disease or other condition. Sometimes patients given a placebo treatment will have a perceived or actual improvement in a condition, a phenomenon commonly called the “Placebo Effect.” In research, placebos are given as a control treatment that is directly compared to the experimental treatment as a way to assess the effectiveness of the study.
What is referred to as a ‘control’ or “control group?”
Experimental observations are evaluated in relation to a standard or a ‘control’. In many clinical trials one group of patients will be given an experimental drug or treatment, while the ‘control’ group is given either a standard treatment or a placebo. By comparing the results from each group the research team will draw possible conclusions.
Content on this page has been extracted from CanadaTrials.com,U.S. National Library of Medicine (NLM) and ClinicalTrials.gov.
