The Process Involved In Clinical Trials On New Drugs

Whenever a new drug is developed, it has to be approved before it goes to the market. The entire process undergoes clinical trials and this is closely monitored by the Food and Drugs Administration (FDA). The FDA's duty is to review all the results that were done on the research study ensuring that it is safe which means that the benefit you get from the drug outweighs any side effects the new drug have. FDA also sees to it that the new drug is useful in treating the illness it was intended to.

Once the new drug has shown promising results from the various tests, it has to be tested on human beings during the research studies. Once the drug has was proven to be safe and gives excellent result in treating the intended disease, the sponsor of the research study will now file a New Drug Application (NDA) or a license to FDA. Once the new drug is approved by the FDA, the new drug is now ready to be marketed.

New drug that was developed will undergo different process of pre-clinical testing and researches wherein animal models are used to test for its toxicity and efficiency. The research and testing process would take about four years and once it shows promising results it will now be ready for clinical trials which involves the testing on the human being.

During the Phase I one of the trial it will test for the safety and the right dosage of the new drugs. This usual takes about two years and once this stage is successful, it will forward to Phase 2 of the trial. This will again consume at least two years of research to test for the efficiency and the possible side effects of the drug. Again if this is successful, the research study will move forward to Phase 3 wherein they will study on the rating of its effectiveness compared to the existing standard medication. This will take up to three to four years wherein the results of the trials are reported on the medical journals and on professional and scientific conferences.

After all the clinical trials were successful, the sponsor on the research study will submit an application to the FDA. FDA on the other hand will have series of tests on the new which will take another year and once approved, it will be marketed for consumer's consumption.

For the latest in clinical trials be sure to check with your local medical organization, http://www.trialfacts.com