Clinical Trial Phases
Clinical trials are used to determine the influence after human take drugs, medical devices or treatments. Clinical trials have multiple phases, that build on one another. Each phase helps answer different questions about the new drugs/medical devices/treatment and needs to be completed successfully before moving on to the next phase.
The content of clinical trial phase might be few different between drugs and medical devices, but all the clinical trials are aimed to prove the safety and efficacy of drugs and medical devices.
Clinical trials are designed, reviewed and completed carefully by following international standard, such as GCP or ICH.
All clinical trials need to be approved before they start. According to the requirements of different protocols, everyone of all ages including children can participate in clinical trials. In general, there are 4 phases in clinical trials:
1. Phase I: small group of health subjects test new drugs/medical device for the fist time to evaluate the safe dosage range and whether there have side effects.
2. Phase II: the number of subjects is more than Phase I, about 100-300 subjects who has indication of products. The period of this phase usually lasts from several months to two years. Phase II mainly aimed at the effectiveness of test doses in phase I and the evaluation of side effects.
3. Phase III: Phase III is much larger than Phase I or II. This phase involves hundreds or even thousands of subjects. Phase III are designed random allocation, double-blind, controlled trials in multi-center. This phase aim to evaluate the safety and efficacy and often the step right before a new drugs/medical device is approved.
4. Phase IV: This phase is follow-up stage after the drugs/medical devices goes on the market. There is no requirement for the number of subjects and use the treatment doses that be determined in the previous phases. Phase IV is usually long-term follow-up period for verify the indication and side effect of authority application.
TALENT has great experience and professional of clinical trails which can provide the service about clinical trial design and management. Please contact us and we will get in touch.