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Phase I Trials: Primarily concerned with the drug's safety. Done on Healthy subjects and its the first time studied in humans. Amount of subjects to be used is approximately 20-100. Done in a hospital setting so side effects can be monitored more closely. Phase II Trials: Once tested in healthy subjects, its time to be done on the diseased subjects in which the drug is intended to cure or help. They are randomised studies as well in which case its usually blinded to all involved in the study and a Placebo is used. Several hundred subjects are tested and the company is concerned here with safety and efficacy of the drug. Lasts for about several months to a few years. Phase III Trials: Several hundred to several thousand subjects are needed for ph. 3 trials. Usually safety and efficacy again are involved to check more closely though, on severity of the adverse events. These studies can last years. Looks at study benefits, risks, etc. Phase IV Trials: Phase IV involves marketing the drug. Once the study is ended in Phase III, the study needs to be marketed. The FDA is notified of the end and results and the company applies then for the NDA (new drug application). The marketing is done for the public and looks at long term safety.
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What are three things a clinical trial would include?
What should be included in a clinical trial
How would you register for clinical trial patient recruitment?
You would register for clinical trial patient treatment by contacting a company that specializes in the recruitment of people for clinical trials. One such company is called Clinical Connection.
Define Post marketing surveillance in clinical trial?
PMS is defined as a new drug development i.e, pharmacovigillence
How many phases are included in a drug clinical trial?
There are three phrases in the drug clinical trail. Each phrase is important part the the drug clinical trail. You can not proceed to the next step without finishing a previous step.
What is clinical trial data services?
Clinical Trial Data Services (CTDS) are an organization that focus on clinical research. The organization also provide understanding about clinical trial processes, for example.
When was Clinical Trial Service Unit created?
Clinical Trial Service Unit was created in 1975.
What industries use a clinical trial management system?
The clinical trial management system is used in biochemical, pharmecutical industries and clinical research institutions. The system itself is used to correlate large amounts of data concerning the clinical trial.
What are the pros and cons of participating in a clinical trial?
What are the pros and cons of independent members in clinical trial committees having volunteers in these positions
What is clinical trail management software?
Clinical trial management software helps in the process of recording various medical results obtained during the clinical trial phase of medical testing.
What is a limitation of a clinical trial?
Hospital costs
What is observed in a clinical trial?
An actual patient
What basis only small number of volunteers selected in phase1 and more numbers in other phases in clinical trial?
The answer is that depends upon many reasons like :1: ICH Guide lines2: Ethical issues === === == ==
