Each clinical trial undergoes a series of phases, with each phase building on the other and each designed to answer specific questions. These phases (I-IV) record specific information, and depending on the results, the clinical trial may be halted temporarily or even terminated if data shows the treatment to be unsafe or ineffective:
- Phase I: These trials test an experimental treatment on a small group of participants, often containing healthy individuals in order to determine overall safety, side effects, and dosages.
- Phase II: Lasting up to several years, this next phase increases the trial sample size based on phase I safety approval and emphasizes treatment effectiveness on people who have a certain disease or illness.
- Phase III: This phase amplifies the process by studying different populations and different doses, while also using the new drug, device, or treatment alongside others to monitor compatibility. If all goes well, the FDA will approve the experimental drug, device, or treatment.
- Phase IV: After being approved by the FDA, the experimental medication or device’s effectiveness may be monitored in large and diverse populations. Often, certain side effects may not become clear until more individuals have used it over a greater period of time.
This post was written by ClinicalTrialAdmin