A clinical trial is a research study that for example looks at how well a potential (investigational) new treatment or diagnostic drug or method works in humans.
It is required by law that clinical trials are conducted before seeking and obtaining approval by national authorities to start the general use of a new treatment or diagnostic drug in the planned patient population.
Clinical trials are designed to answer specific questions about:
- safety and tolerability, for example side effects
- efficacy and benefits
- whether some people benefit more than others
For example, a clinical trial may look at whether a new drug helps lower blood pressure in people with high blood pressure.
By participating in a clinical trial, you can help bring new treatments and diagnostic drugs market that eventually will help other people.
Approval of a clinical trial
Clinical trials need to be approved by experts and authorities before they are initiated. Among other things, the study protocol (outlining the study procedures), patient information, informed consent form, and other relevant documents will be submitted to the relevant independent ethics committee (IEC) and/or Independent Review Board for all participating sites and/or countries in accordance with national laws, guidelines, and Good Clinical Practice provisions.
Who can participate in a clinical trial?
Each study has its own rules about who can — or cannot — participate. This is called “eligibility.”
Your eligibility may be based on your age, gender, overall health, type and stage of a disease, treatment history, and other conditions. Not everyone is offered to participate. You may not be eligible simply because you do not have certain characteristics.
Things that allow you to participate are called “inclusion criteria,” and things that disqualify you are called “exclusion criteria.”
People who participate in clinical trials do so freely and of their own will. They are volunteers. In many studies, the volunteers will have a common health condition, such as kidney disease, diabetes or a specific cancer type.