Understanding Clinical Trials
Testing the Safety and Efficacy of New Medicines
Clinical studies, or clinical trials, are important and necessary steps in making sure new medicines are safe and effective. This research is required by the U.S. government before a medication can be sold in the U.S. In studies, researchers evaluate the medicines to determine whether they perform as expected, improving the health of patients, and for any unintended problems or concerns. Study doctors often also evaluate whether medicines for different diseases can be taken together, and other questions. Such testing is done in a clinical setting, under controlled conditions.
Phases of Clinical Studies
Clinical studies are organized in specific steps or phases. Each phase addresses different research questions, and each phase builds upon the previous phase until the drug is shown in all studies to be safe and effective.
Phase 1
Phase 1 studies are the first time the investigational medicine being evaluated is given to cancer patients. Phase 1 studies are done in a small number of patients to see how much of the study medicine may be safe to take.
Phase 2
In Phase 2, study doctors examine if the medicine being researched is effective at treating disease. They also continue to monitor the study drug's safety. Most Phase 2 studies enroll between 50 and 300 people.
Phase 3
A Phase 3 study has two goals. The first is to understand whether the study medicine is safe for patients to take. The second is to continue to study how effective the investigational medicine is in treating the disease, often times in a larger group of patients (several hundred to several thousand, depending on the disease).
Phase 4
Studies done after a medicine is available for a doctor to prescribe to a patient are called Phase 4 (or "post-marketing") studies.
Regulation and Oversight
The federal government regulates clinical studies and also the study doctors who work in them. Before a study can begin to enroll patients, it must be reviewed by an independent group of scientists and community members called an Institutional Review Board or IRB. The IRB reviews the study to make sure that it is as safe as possible for the study volunteers. They also review the plan for guarding patients' confidentiality and privacy.
Enrolling In or Learning About Clinical Studies
If you're looking for a clinical study, either to enroll, or for more information or results, there are a number of options, such as:
- www.clinicaltrials.gov
- www.centerwatch.com
- Advocacy groups dedicated to the condition you are interested in
- Your doctor, oncologist, hospital, or health insurance provider
Learn about our SNS-595 trials
