1. What are clinical trials?
2. Why are clinical trials done?
3. Where can people find out about clinical trials?
4. Why should I consider participating in a clinical trial?
5. Where are clinical trials conducted?
6. What is “informed consent”?
1. What are clinical trials?
A clinical trial is a research study created to answer specific health questions. These questions may involve new investigational treatments, new combinations of medicines, or new approaches to preventing and detecting disease.
Carefully conducted clinical trials are the only way to find treatments that work in people, and new ways to improve health.
Clinical trials 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.
2. Why are clinical trials done?
Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Some trials compare existing treatments to determine which is better. For most trials in the United States, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration (FDA).
3. Where can people find out about clinical trials?
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.
4. Why should I consider participating in a clinical trial?
For those who are eligible, taking part in clinical trials include the following:
- Getting actively involved in their own health care
-
Having access to study-related care for the condition being studied, since investigators are often familiar with 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 clinical trial, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
5. Where are clinical trials conducted?
Clinical trials 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.
6. What is “informed consent”?
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an "informed consent" form before joining the study, indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent helps ensure that a prospective clinical trial participant understands what’s involved in the trial.
Source: U.S. Source: U.S. Food and Drug Administration. Basic Questions and Answers about Clinical Trials. Available at: http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html. Accessed June 24, 2010.