Understanding Clinical Research
There are many obstacles and failures to achieve medical success; medical professionals confront and overcome these regularly. Have you ever think of how medical professionals solve these problems? Clinical Research is the key to jumpstart and people working and contributing efforts in the clinical research industry are locating directions to lead to destinations.
The term “clinical research” refers to studies, or trials, that are done in people. As the researchers design the clinical study, they will consider what they want to accomplish for each clinical research phrases. However, before entering the stage of clinical trials with people, researchers will run tests and treatments for accessing in preclinical research. Remember, preclinical research is not done with people. After preclinical research, tests and treatments will go through a series of clinical trials to see whether it is safe for and work in people. Do you know the phases of clinical trials?
- Phase 0
Phase 0 trials are the first clinical trials done among people. The purpose of phase 0 is aiming to learn how a drug is processed and how it affects the human body. In these trials, a small dose of a drug is given to about 10 -15 people.
- Phase I
Phase I trials access the safety of a drug or device. The purpose of phase I trials is aiming to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 20 to 100 patients and healthy volunteers, and the process can take several months to complete. Approximately 70% of drugs move to the next phase.
- Phase II
Phase II trials aim to assess the efficacy and side effects of a new drug. Phase II trials are done in larger groups of patients – up to several hundred patients. Patients are closely watched to see if the drug works. If a drug is found to work, it can be tested in phase III clinical trials.
Approximately 33% of drugs move to the next phase.
- Phase III
Phase III trials aim to further determine the efficacy and monitoring of adverse reactions of the new drug. Study participants in phase III trials are up to 300 – 3000 patients who have the disease or condition. The phase III stage involves randomized and blind testing. Once phase III is complete, pharmaceutical companies can request FDA approval to advertise the drug.
Approximately 25 to 30% of drugs move to the next phase.
- Phase IV
Phase IV trials are testing new drugs approved by the FDA. It may involve several thousand patients who have the disease or condition to participate. The purpose of phase IV trials is to allow for better research on side effects and safety.
Interested in solving medical obstacles?