What are research studies?
A research study is created to answer specific health questions. These questions may involve new treatments, new combinations of medicines, or new approaches to preventing and detecting disease.
Carefully conducted research studies are the safest and fastest way to find treatments that work in people, and new ways to improve health.
Research studies are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and the length of time for the study.
Why are research studies done?
Many research studies are done to see if a new drug or device is safe and effective for people to use. Some studies compare existing treatments to determine which is better. For most studies in the United States, researchers, doctors, and other health professionals administer the research studies according to strict rules set by the Food and Drug Administration (FDA).
Where can people find out about research studies?
One way to find information about research studies 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 trial?
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 study-related medical care for the condition 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 studies, 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 have been told 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 in the study.