WHAT IS A CLINICAL TRIAL?
A clinical trial is a research study using human volunteers to study the safety and effectiveness of a drug, treatment, or device in changing the course of health outcomes. Clinical trials follow basic scientific research that has been conducted to better understand disease pathways and pre-clinical studies that test treatment effects in the laboratory.
Trials can be conducted to prevent (e.g., immunization trials) or treat disease (e.g., drug and therapeutic device trials). In ALS research, most trials have been drug trials. Drug trials study whether experimental (new) treatments or new ways of using known therapies are safe and effective under controlled conditions outlined in the study protocol.
WHAT ARE THE BENEFITS AND THE RISKS OF PARTICIPATING IN A TRIAL?
Benefits:
- Access to superior healthcare by leading ALS physician researchers and care teams
- Access to new treatments before they become generally available
- Opportunity to make valuable contribution to clinical ALS research and help others living with the disease now and in the future
Risks:
- Unknown side effects
- Treatment may be found to be of lesser value than standard treatment, or not effective for some individuals
- Potential time involved with traveling to the study site, receiving treatment, tests, and possible hospital stays
- Potential costs associated with travel to study site
HOW SAFE ARE CLINICAL TRIALS?
Clinical trials in Canada are regulated by the previously mentioned TPD, similar in function to the FDA in the United States. All federally regulated trials must be approved and monitored by an independent committee of doctors, scientists, advocates and others to ensure safety. These committees are called Institutional Review Boards (IRBs) or Ethics Review Boards (ERBs).
The review boards study and approve all study-related documents such as protocols, Informed Consent forms, physician credentials and eligibility, and patient recruitment methods. Data and Safety Monitoring Committees are also common to clinical trials. These independent groups of experts carefully monitor data to detect benefit or harm, and validity of results.