Clinical trials begin with an idea in a lab. Researchers thoroughly test potential treatments in the lab and in animals before ever beginning trials in humans. If these lab and animal tests are successful and the therapy looks promising, the researchers will begin to conduct research studies beginning at Phase 1 and moving through to Phase IV:
- Phase I clinical trials test whether drugs are safe to use in humans.
- Phase II clinical trials test the effectiveness of a drug or medical device. This stage can last from several months to a few years, and generally involves several hundred participants.
- Phase III clinical trials are typically the largest. They involve anywhere from several hundred to several thousand participants in a randomized, blind study. This testing phase can last several years as the FDA gathers thorough data about the drug’s effectiveness and potential side effects.
- Phase IV trials, also known as Post Marketing Surveillance Trials, take place after a drug or device has been approved. In this phase, pharmaceutical companies monitor a drug’s long-term effectiveness and impact, compare it to existing trials in the market, and determine the cost effectiveness of the new treatment.
- It’s a big decision to take part in a clinical trial, and it’s important that patients and caregivers fully understand all of the benefits and risks before enrolling. We’ll discuss these in the next section.
Find Your Clinical Trial Match —Answer a few questions to find clinical trial opportunities near you that you may qualify for.Match Me
Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews