Clinical Trials are used to test new techniques of diagnosing, treating or preventing health conditions. The aim is to decide whether something is both effective and safe. Different things are evaluated through clinical studies which include:
- New uses for present medications
- Medical devices
- Medication combinations
Before a clinical trial, examiners conduct preclinical research by using human cell cultures or animal modes. If the preclinical research is favorable, they proceed with a clinical trial to check out how well it works on human beings. Clinical trials take place in various phases while various questions are asked. Every phase tends to progress on the results of previous phases. Read more to learn about what occurs during each phase.
What carries out in phase 0?
Phase 0 clinical trials are done with a small number of people, normally fewer than 15. Examiners use a very small dose of medication to ensure safety to humans before they begin to use it in higher doses for the next phases. If then medication proves different than expected, the examiners will likely to do some extra preclinical study before determining whether to continue with the trial.
What carries out in phase 1?
At the time of phase 1 clinical trial, examiners spend various months observing the effects of the medication on about 20-80 people with no existing health conditions. This phase aims to find out the highest dose of humans with no serious side effects. Examiners observe participants keenly to check out how their bodies react to the medication at this phase. Besides evaluating ideal dosage and safety, examiners also find the best way to administer the drug such as intravenously, orally or topically. As per the FDA, nearly 70% of the trusted source of medications proceeds to phase 2 clinical studies.
What carries out in phase 2?
Phase 2 clinical studies include several 100 participants who are staying with the condition that the new medication will surely do the treatment. They are normally given the same dose which was found to be safe in the previous one. Examiners observe participants for various months or years to check out how effective the medication is and to collect more details on any side effects it may cause. While phase 2 clinical studies include more participants, it is still not huge to determine the full safety of a medication. However, the information gathered during this phase assisted examiners to get methods for conducting phase 3.
What carries out in phase 3?
Phase 3 clinical studies usually include 3000 participants who have the condition that the new medication will surely come up with the treatment. This phase aims to examine how the new medication works when compared with existing medications for a similar condition. For this purpose, examiners use a method called randomization. This includes a random selection of some participants to get the new medication and others to get an existing medication. These trials are mostly double-minded which indicates neither the participant nor the examiner knows which medication the participant is going through. This assists to remove bias when interpreting results.
What carries out in phase 4?
Phase 4 clinical trials occur after the approval of the FDA. This phase includes 1000 participants and can last for many years. Examiners use this phase to receive more details about the medication’s long-term effectiveness, safety and any other advantages.