Clinical trials are done to test new diagnostic, treatments and prevention methods to treat any health condition. The main aim of a clinical trial is to test whether a treatment of diagnosing method is safe and effective or not. Clinical trials evaluate variety of things that include medications, medical devices, medical combinations and how an existing medication can be used in new way. The preclinical trials are done on animal models or human cell cultures by the investigators.
If the result of preclinical trial is good then further trial is done to show its effectiveness on humans. There are several phases of a clinical trial. Every phase depends on the previous phase and its results. Let us understand phase 2 clinical studies and other phase as well to know what happens in each phase during the clinical trial process.
The trial begins with phase 0 where only few humans are given a small dose of medication. If the expected results are achieved then phase 1 will be started otherwise few more preclinical research will be conducted.
The trial is done on more than 50 people for few months and checks its effectiveness. The people tried under trials have no serious health conditions. Here the higher dose a human can take without getting any negative effect is checked. Close observation on their bodies is done to check their reaction. Moreover, they also check for the best way in which a drug can be consumed by the human. This phase yield only general result.
In phase 2 clinical studies the large group of participants is tested. These participants are those having conditions for which the medication or drug is developed. The same dose from previous phase is given to them for months or years. During this time they study about their side effects and effectiveness.
However, the safety of drug is still hard to demonstrate as large number of participants is involved. The data collected is used to conduct further investigation. Few key points of this phase are as follow.
Key points of phase 2 clinical studies
- A group of patient with same medical condition participates in this phase
- Same dose of drug found to be safest in phase 1 is given to them
- Few patients can be assigned different treatments to be invested for phase 3 trial with different dose of drug
- No inactive treatment is used
- Phase 2 clinical studies are usually done on patients with major conditions and even done in offices of doctor or hospital
Since large number of patient are involved thus there are better chances of getting any side effects.
Safety and effectiveness is compared with existing medications. A random participant is chosen to test the new medication.
This phase is done after the approval of new medication where thousands of participants are involved. Long term safety and benefits of medication is found here.
Every phase is important of clinical research before the drug reach to public for use.