About Research Studies
What is a research study?
A research study (also known as a clinical trial) is a medical study that is designed to answer questions about the safety of potential new drugs and to find out how well they work. Research studies must be performed before a potential new drug can be approved for use in patients.
Why are research studies important?
Research studies are used to test investigational products before they are sold to the general public. The testing that takes place during the studies provides information regarding the safety and effectiveness of the potential product.
Where can people find out about research studies?
One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is eligible to participate, locations, and phone numbers to call for more information.
Why should I consider participating in a research study?
For those who are eligible, taking part in research studies offers several benefits:
Getting actively involved in their own health care
Having access to potentially new research treatments
Having access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied
Helping others by contributing to medical research
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
Where are research studies conducted?
Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.
What is “informed consent”?
The government requires researchers to give prospective participants complete and accurate information about what will happen during the study. Participants must sign an "informed consent" form before joining the study, indicating they understand that the study is research, and that they can leave the research study at any time. This informed consent helps ensure that a prospective research study participant understands what’s involved.