Basic research advances health knowledge and identifies a solution to a specific health problem in the laboratory.
The care trajectory is the continuum of care an individual receives to treat a medical condition. The care trajectory can include multiple treatments and care services at different times and locations.
A caregiver is a person who provides ongoing or occasional support to one or more loved ones. The loved one may have a temporary or permanent physical, psychological or other disability, and shares an emotional connection—whether or not related by family—with the caregiver.
Cell therapy involves placing or transplanting cells to treat a medical condition. A stem cell transplant for an individual with multiple myeloma is an example of cell therapy.
Clinical research seeks, through clinical trials, to show that the possible new treatments are effective and safe for humans. It is based on previously obtained laboratory results (during the stages of basic research and preclinical research).
Depending on the study treatment in question, clinical trials are carried out with participants who are healthy or who have a specific medical condition.
A diagnostic tool helps medical personnel identify medical conditions. A diagnostic tool can be a questionnaire, a medical device, software, etc.
are characteristics that possible participants must have to participate in a clinical trial, such as age, type and stage of the medical condition or previous treatments. Eligibility criteria include:
- Inclusion criteria: characteristics that individuals must have in order to participate in the trial.
- Exclusion criteria: characteristics that individuals must not have to be included in the trial.
An experimental treatment (or study treatment) is a treatment that has not yet been tested to determine its effectiveness and safety. All drugs, medical devices and other treatments must be evaluated in clinical trials before they are made available to the general public.
Gene therapy is a technique that modifies one or more genes (DNA) in cells to cure a medical condition that can be caused by a defective gene. Gene therapy can also change the genes of cancer cells to destroy them.
Health innovations include new health products, practices or technologies to improve or maintain the health of the population.
Studies on laboratory animals are essential to better understand the overall effect of the treatment on a living organism. A treatment, even if it is intended to affect one part of the body or a specific biological system (for example, the circulatory system, the respiratory system or the nervous system), may affect other parts of the body or other biological systems. Since animals have a body similar to that of humans, particularly in terms of vital functions such as breathing, digestion, movement and reproductive functions, testing a promising treatment in animals can therefore confirm its effects and safety before testing it in humans.
As with clinical trials, studies on animals are highly regulated and require ethics board approval. In Canada, the Canadian Council on Animal Care (CCAC) plays an important role in the scientific community. It creates and establishes ethical animal practices for rigorous and valid research results.
A market authorization allows the manufacturer of a health product to make it available to the public. This authorization is issued by Health Canada when a manufacturer presents strong scientific evidence of the safety, efficacy and quality of the health product. After receiving market authorization, the manufacturer must continue to monitor the health product and provide updates on its safety and efficacy to Health Canada at set times.
The patient experience describes the entire experience of an individual with a medical condition (symptoms, quality of life, use of the healthcare system, etc.). The patient experience is personal and may differ from individual to individual, and even between individuals with the same medical condition.
Pharmacoeconomic value is an estimate of the economic benefit of a health product (for example, the high cost of a health product is compared to the cost associated with not having that product). The purpose of estimating pharmacoeconomic value is to justify coverage of a health product by Régie de l’assurance maladie du Québec (RAMQ).
A placebo is a substance that does not contain any drugs but has the same appearance as a study treatment (same shape, size, colour and taste if it is an oral treatment). It is administered in the same way (orally or by injection). In some cases, for example, in oncology, the placebo may be the standard treatment, which ensures appropriate medical management of participants.
For some people, simply receiving a placebo treatment improves their medical condition. This is known as the “placebo effect.” The use of a placebo in one of the groups in a clinical trial allows scientists to evaluate the actual efficacy of the study treatment. The use of a placebo must be approved by a research ethics board, and participants are informed when a placebo is used in a clinical trial.
Preclinical research is based on the knowledge gathered during basic research. It is conducted on animal or human cells (in vitro) or on laboratory animals (in vivo) by university research centres or drug companies.
When preclinical research confirms that the treatment on animals is promising, and if the necessary approvals are obtained, clinical research can begin with a first clinical trial on humans.
Research ethics boards are independent bodies that ensure respect for the dignity, safety, well-being and rights of participants in clinical trials. Ethics boards approve and monitor clinical trials closely, and may suspend or cancel all or part of a trial at any time. In Quebec, research ethics boards may be attached to ministries or to academic or health institutions, such as university faculties, integrated health and social services centres (CISSS) or integrated university health and social services centres (CIUSSS) or university hospital centres (CHU). These boards are made up of experts from various fields.
The research protocol gathers all the information related to the conduct of the clinical trial. It explains why the trial is being conducted (background, hypothesis and objectives), how it will be conducted and how the safety of the participants will be ensured.
Risk factors are individual and environmental characteristics that increase the likelihood of a person developing a medical condition. The presence of risk factors does not mean that a person will necessarily develop this medical condition. For example, people with the BRCA2 gene will not necessarily develop breast cancer, even if their risk factor for this medical condition is higher than average.
A side effect is a reaction to a health product that is different from the intended reaction. A side effect may be expected or unexpected, mild or severe, temporary or permanent, harmful, neutral or positive. An adverse effect or adverse side effect is a harmful and unwanted side effect resulting from the intake of a health product.
The onset of side effects varies from person to person and from treatment to treatment. It is important to ask medical staff about the possible side effects of a treatment.
The sponsor takes ownership of and responsibility for all stages of a clinical trial. In most cases, the sponsor also funds the clinical trial. The sponsor may be a drug or biotechnology company, a university, a healthcare institution, a volunteer group, a private organization, a government health agency, a physician or a member of the medical staff.
Outside of a clinical trial, a standard of care is the standard treatment that is usually prescribed to cure or reduce the symptoms of a specific medical condition.
A health product is used to treat or prevent a medical condition; its therapeutic indication shows how it should be used and the population for which it is intended. For example, ibuprofen is indicated for reducing fever and treating pain or inflammation caused by many conditions such as headaches, toothaches, back pain, arthritis, menstrual cramps or minor injuries.
Therapeutic value is an estimate of the benefit a health product can have for people with a medical condition. In Quebec, Institut national d’excellence en santé et en services sociaux (INESSS) assesses therapeutic value based on two criteria:
- The presence and significance of a health need to be met.
- The health product’s ability to benefit the public.