A clinical trial is a research study that tests whether a potential therapy is safe and effective for patients. It evaluates new drugs, behaviors or devices. It reveals whether potential therapies work for particular diseases or groups of patients. Clinical trials provide the best available data for the approval of new disease treatments.
There are two main types of clinical trials: interventional studies and observational studies.
Interventional trials test whether a specific intervention (such as a drug, device or behavioral change) affects health-related outcomes. In a process called randomization, different groups of people are assigned at random to receive (and not receive) the intervention. Typically, the group that does not receive the intervention — known as the control arm — receives the current standard of care or a placebo (a fake version of the intervention). Interventional trials are typically blinded, so the volunteer is not aware if they are in the control group or receiving the intervention. In a double blinded study, the researcher and the volunteer are not aware.
Observational studies place participants in groups based on their characteristics. An intervention is tested in each of these groups. Both observational and interventional studies follow a protocol, a detailed plan for the study written by the trial sponsor and approved by the FDA.
A trial sponsor is an organization that initiates, funds and conducts a clinical trial. This is often a pharmaceutical company, but it can also be a university or another type of research organization. It’s important for potential volunteers to be aware of and comfortable with who is sponsoring the trial.
Anyone can be a potential trial volunteer. Many people view clinical trials as a last resort only to be relied upon when all other options have been exhausted; however, this is not the case. Research studies need a variety of participants to enroll. Some trials seek volunteers who have been recently diagnosed, while others only need those who have been living with a condition long-term. Certain studies may require patients who have had different treatment experiences in the past. Every trial is different, but with thousands of studies recruiting, there is likely a trial that is right for you.