A clinical trial (also called clinical study) is scientific research designed to test if a medicine or medical device is effective and well tolerated for use by people.
Most ideas for a new medicine or treatment start in a laboratory. After researchers test the product in the laboratory and in animal studies, the most successful treatments move on to clinical research, where they are tested in people who volunteer to be study participants.
Throughout the study, information is collected to answer specific research questions.
Participant safety is a top priority. Researchers evaluate the drug/device to see if it is safe and how well it is tolerated, while documenting any reported side effects.
The drug/device is evaluated to see how much is needed and how well it works compared to either a placebo or the current standard treatment, if one exists.
The trial is used to define categories of patients the investigational product is most appropriate for treating, including type of disease, severity and other criteria.
Trials can help researchers gain a better understanding of how a disease affects not only the human body, but also people’s lives.
Every prescription medicine available in the U.S. must go through a clinical trial process. The process includes different phases of research. The studies may take place at a hospital, doctors’ office or clinical research center and are conducted by doctors, nurses and other health care team members.
The safety and well-being of study participants are top priorities for the sponsors, doctors, nurses and research professionals who conduct clinical trials. If you choose to join a study, your health will be closely monitored and your care will be adjusted if the medical team thinks it’s in your best interest. If you decide at any point that you wish to end your study participation, you may do so without providing a reason.
Throughout the entire clinical trial experience, many people provide trial oversight to safeguard study participants. These include the sponsoring organization that develops the study plan and funds the research, the doctors and nurses who provide care during the study and an independent committee called the Institutional Review Board (IRB).
Medical institutions, pharmaceutical companies, federal agencies or others that fund the research study to see if the investigational product is safe and effective.
Doctors’ offices, hospitals, university medical centers and clinical research centers that enroll study participants and conduct the clinical trial on behalf of the study sponsor.
Independent committee of doctors, statisticians, and members of the community who ensure the clinical trial is ethical and the rights of the study participants are protected.