Melissa Benoit

What is a clinical trial?

 

At the Toronto Adult CF Clinic we conduct many different types of research studies.

research

What is a Clinical Trial? In order to determine if a new drug or medical device is safe and effective, it must be tested very thoroughly through the clinical trial process.  See definition of different phases of trials below from clinicaltrials.gov. At our clinic we mostly conduct Phase 2, Phase 3, Phase 4 and Observational studies.
Learn more about research terminology by clicking here.

 

Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted. 

Phase 2: This phase of the clinical trial process gathers preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. 

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. 

Phase 4 (Open Label): Studies occurring after Health Canada has approved a drug for marketing. These including postmarketing requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use. 

Observational Research

In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan. Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.

www.ClinicalTrials.gov  is an excellent source to find information on ongoing trials in CF and other diseases.