Importance of Clinical Trials Simply we can say that Clinical trials are step by step processes which are totally depend upon the stage of drug development and research. Clinical trialsare very crucial and important part of clinical research process and practices. It includes medical research and effective and safe drug development. Clinical trials are performed to gather information to generate efficacy data for health intervention. Health intervention consist trials of drugs, therapy protocols, devices and diagnostics. When a pharmaceutical company or a government organization develops a new drug, it must have to approve that drug from the government of that particular country where the drug is developed and is to be sold in the market. For government approval for a drug is necessary because it ensures that the drug is clinically safe. If a pharmaceutical company wants to sell its drug internationally then approval from FDA is necessary. Before introducing a new drug into the market, pharmaceutical companies conduct many Clinical trials and gather and generate efficacy data related to that drug. Drug trial initially performed over animals and researchers closely monitor all the activities, effects and side effects of drugs over animals. If a drug proved clinically safe on animals then researchers conduct drug trials on human body. For this purpose volunteers and patients are enrolled into different pilot groups. Sponsors pay volunteers and patients for Clinical trials. Initially trials are performed over few patients. As the positive efficacy data and safety information is gathered researchers perform drug trials on large number of patients. Trialsarebroadly divided into two categories as observational study and interventional study. In the United States of America National Institutes of Health (NIH) divides drug trialsinto six sub categories as compassionate use trials, prevention trials, quality of life trials, diagnostic trials, treatment trials and screening trials. As mentioned earlier Clinical trials are continuous process, these are divided into five phases as 0,1,2,3 and 4. Phase 0 includes Pharmacodynamics and Pharmacokinetics. Phase 1 is concerned about Screening for safety. Phase 2 is related to Establishing the testing protocol in the trials. In phase 3 researchers perform final testing. Phase 4 is related to post approval study. When pharmaceutical companies or biotechnology companies or governmental organizations wants to perform any trials for any drug the main problem they have to face is the increasing cost of the project because as the number of volunteers and patients is increased the amount of compensation and other expenses also increased. In this situation companies outsourced the clinical trials to any other companies which deal with all the related issues associated with trials. For more information about Clinical Trials click here.
Published on Feb 25, 2013
Published on Feb 25, 2013
Simply we can say that Clinical trials are step by step processes which are totally depend upon the stage of drug development and research.