Clinical Trials (also referred to as Clinical Studies or Interventional Studies) are research studies designed to explore a specific medical strategy, treatment, medical product (drugs or devices) or a change to procedures or to a participant’s behaviour (ie. diet). The outcome of the product or approach is unknown and the process has usually been designed to compare a new medical approach to a standard one that is already available or to a placebo which contains no active ingredients or to those receiving no intervention.
Before a research study meets `Clinical Trial` criteria, it must undergo a very long and careful research process. This process usually begins in the laboratory, where new ideas are initially developed.
If a new idea seems promising, in the initial stages, the next step may involve animal testing. This shows how the approach affects a living body and whether it’s harmful. It is also important to remember that an approach that works well in the lab doesn't always work well in humans. This means that eventually, research in humans is needed.
Generally, clinical trials start with small groups of participants, to find out whether a new approach causes any harm to humans. If the initial results show promise, the clinical trial size may increase. Before a clinical trial starts, the research must prove that the trial follows strict scientific standards and will remain safe and effective for participants.
The goal of a clinical trial is to produce the best data available for health care decision making through research. The results of these clinical trials are important, as ultimately results are important because they advance medical knowledge and help improve patient care.
Note: It is important to understand that participants must be eligible. This means that they must meet the listed protocol. These standards are referred to as eligibility criteria. Participants must meet a list of standards or they will be disqualified.