Clinical trials are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. A clinical trial is conducted to answer questions about a certain disease, to test new treatments, or to investigate new ways of using known treatments.
In many cases, the therapies and drugs investigated in clinical trials are not approved by Regulatory Agencies (such as the Food and Drug Administration (FDA) in the United States), and the benefits and risks of taking the treatment are not well known. Clinical trials are used to determine whether treatments are safe and effective for a particular disorder. The clinical testing of experimental treatments or drugs is generally done in three phases with different purposes. The early phases focus on testing safety in a small number of study subjects. Later phases are conducted to further test safety and also test potential benefits. Each successive phase generally involves a larger number of people. The knowledge gained from years of clinical trials may ultimately allow pharmaceutical companies to offer new and better options to patients.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own healthcare, gain access to new reserach treatments before they are widely available, and help others by contributing to medical research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate which are based on factors such as age, gender, type of disease, etc. These factors are used to identify appropriate participants for each trial and keep them safe, and also help ensure that questions being studied can be adequately answered. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.