Clinical trials are an integral part of advancing scientific research and delivering promising new treatments. Research gathered from a clinical trial can help to advance our knowledge in preventing, detecting or treating a disease. This research could lead to safer and more effective treatments, an improved quality of life for those affected by a disease and could ultimately lead to a cure.
There are several reasons why one might want to participate in a clinical trial. A healthy volunteer may choose to be involved to advance medical research. A person living with an illness may choose to get involved in a clinical trial because existing treatments have failed and their participation may give them access to new, possibly cutting-edge treatments that may improve their health condition. Getting involved in a clinical trial may also give a participant access to expert care and detailed health monitoring. As well, participating in a clinical trial is a step toward bringing improved treatments to the market and increasing treatment options for those suffering from the same disease or condition.
A clinical trial is a rigorous study involving human volunteers to test the safety and/or effectiveness of an experimental treatment, a medical device or procedure. It may also involve an alternative use of an existing treatment or a combination of treatments.
Typically, prior to trials in humans, safety and effectiveness studies are conducted in animals providing ‘preclinical’ safety and efficacy data. If there is sufficient data to support advancing an investigational treatment to human trials, the pharmaceutical company developing the treatment then submits an application to one or more regulatory agencies. This application contains data from laboratory studies, including research in animals, to support research of the investigational product in humans. It also contains a clinical trial protocol which details how long the clinical trial will take, how many participants will be involved, the tests and medical procedures involved and the goals of the study. In parallel to this regulatory review, an ethics board also reviews these materials and any information that will be provided to a potential trial participant in order to protect the rights of participants and to ensure transparent, fair and ethical communication.
It typically takes 5 – 10 years of laboratory, animal and human clinical research before an investigational treatment, medical device or procedure can be considered for market approval. There are a number of clinical trial stages before an experimental drug or device becomes commercially available.
At each stage, a pharmaceutical company may determine there is not sufficient evidence to support advancing the product to the next successive stage and may choose to discontinue development.
Anyone considering involvement in a clinical trial should conduct due diligence to ensure the clinical trial is a fit for their needs. If you are considering participating in a clinical trial, here are some important tips to think about:
Clinical trials ensure that any investigational treatment, medical device or procedure is thoroughly investigated to assess risks and benefits. Without clinical trials, it would not be possible to bring ground-breaking new therapies to those who would benefit from them. Each clinical trial participant contributes to improving our understanding of a disease and advancing a potential new treatment, medical device or procedure. Clinical trial participants have contributed and will continue to contribute to scientific research that will lead to improving diagnosis, prevention and the treatment of disease and improving the quality of life of those living with illnesses and advancing towards a cure.
Dr. Hal Gunn is the CEO of Qu Biologics, a biotechnology company developing Site Specific Immunomodulators (SSIs), new investigational immunotherapies designed to activate our body’s innate immune response and restore normal immune function in the targeted organ or tissue to reverse the chronic inflammation underlying many diseases, such as inflammatory bowel diseases. Qu Biologics is recruiting participants for three clinical trials in Crohn’s disease, ulcerative colitis and lung cancer.