Prior to FDA approval, the safety and effectiveness of drugs are tested in three main phases of clinical trials: phase I, II, and III. Phase I clinical trials mainly seek to understand if a new drug is safe. They also determine where in the body the drug goes, how it is eliminated from the body, its effects on the body, and its safest dose.
There are risks and benefits to participating in a phase I clinical trial. Some drugs in phase I trials are called “first in human”, meaning that they have been tested in animals but not yet in people. Therefore, risks involving safety, both short term and long term, exist. Benefits include getting access to new treatments that may not be otherwise available, receiving additional monitoring and care, and having the opportunity to contribute to improvements in medical care for future patients.
Read below for information about phase I clinical trials including goals, risks and benefits, and how a drug’s safest dose is determined.
Phase I Clinical Trials 101
- National Cancer Institute (Video): What Are Clinical Trial Phases?
- National Cancer Institute (Video): Patient Safety in Clinical Trials
- Verywell Health: When Are Phase I Clinical Trials Done?
- ASCO: Phases Of Clinical Trials
- Journal Article: Risks And Benefits Of Phase I Clinical Trial Participation
- Journal Article: Dose Escalation Methods In Phase I Cancer Clinical Trials
Finding Clinical Trials
- Metastatic Trial Search: Phase I Trials
- Solid Tumor Trials: Trials That May Include Phase I Trials
Last Modified on September 27, 2023