- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before clinical trials?
- Some facts about clinical trials: Important points to keep in mind
- What are the phases of clinical trials?
- Phase 0 clinical trials: Exploring if and how a new drug may work
- Phase I clinical trials: Is the treatment safe?
- Phase II clinical trials: Does the treatment work?
- Phase III clinical trials: Is it better than what’s already available?
- Submission for FDA approval: New drug application (NDA)
- Phase IV clinical trials: What else do we need to know?
- Who sponsors and runs clinical trials?
- Should I think about taking part in a clinical trial?
- Answers to some common questions about clinical trials
- Other questions you should ask your research team
- What protects the study participants?
- What’s out there? Finding clinical trials
- How do I figure out which study is for me?
- What about cost? Will my insurance cover it?
- What would it be like to take part in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
Submission for FDA approval: New drug application (NDA)
In the United States, when clinical trials show a new drug treatment is more effective and/or safer than the current standard treatment, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval. The FDA then reviews the results from the clinical trials and other relevant information. If the FDA has questions, it may ask for more information or even require that more studies be done. This can extend the approval process to more than 5 years.
Based on its review, the FDA decides if the treatment is OK to be used in patients with the type of illness the drug was tested on. If it is, the new treatment often becomes the standard of care, and newer drugs must then be tested against it before being approved.
Last Medical Review: 09/21/2012
Last Revised: 09/21/2012