Clinical research studies, also known as clinical trials, are studies run by pharmaceutical companies, research organizations, and non-profit groups to learn more about investigational drugs. Research studies are different than regular medical care because the purpose of these studies is to collect information about investigational drugs.
What is an investigational drug?
An investigational drug is a medicine that is not approved by a country’s regulatory health agency and is not available to the public. For example, in the United States, the United States Food and Drug Administration (FDA) must approve a drug before it can be made available to the public.
Regulatory agencies review the results of research studies to determine if an investigational drug is safe and effective. If the investigational drug is safe and effective, it can be approved and made available to the public either by prescription or over the counter.
What happens in clinical research studies?
Typically, an investigational drug is given to study participants over a period of time. Study doctors conduct tests and assessments to learn how the investigational drug affects the study participants’ specific condition (like PTSD) and overall health.
In many studies, a separate group of participants receives either an approved drug or placebo, which looks like the investigational drug but contains no active medication. This group undergoes the same tests and assessments as participants receiving the investigational drug.
The results of these tests and assessments are compared between the groups. This helps doctors and researchers better understand the safety and effectiveness of the investigational drug.
Who participates in clinical research studies?
All research study participants are volunteers. Doctors and researchers rely on people like you who agree to enroll in research studies.
If you’re considering a research study, please know that it’s entirely your decision whether to participate. Should you choose not to participate, your regular medical care will not be affected in any way.
If you do decide to participate in a research study, you will be helping advance medical research.