What are Clinical Trials?

clinicaltrials6In order to test the efficacy of new drugs, a phase of animal and/or human testing must be completed. This allows researchers to test many aspects of the drug in a controlled and monitored environment. Releasing a new and untested drug into the market could run the high risk of not only being ineffective but also deliver a host of unknown side effects and potential health related problems associated with them.

New drugs are given extensive lab testing before being introduced to human trial members. It is believed that the health impacts will then be minimal, it is opened to a period of human testing which can range in time depending on the drug. Each test is controlled and treated individually with separate investigations concurring after each.

What are the Different Phases of a Clinical Trial?

                  There are typically 5 different phases to drug trials, which are as follows:

Phase 1 – Safety. The drug is tested among human trial members to ascertain the effectiveness of the drug, and monitoring the side effects that may occur with a higher or lower dosage. The drug is also tested from start to finish of the trial, from ingestion to digestion, metabolizing, and finally to passing from the body. This phase of testing usually lasts several months.

Phase 2 – Efficacy. This phase of the trial sees it’s trial members expand to include up to a few hundred testers. At this point typically the trial is set as a “blind test” in order to properly gauge the efficacy of the drug. In a blind test, a portion of the testers are given the actual drug, while another portion is given a placebo. This allows both the investigators and the FDA to come up with hopefully similar results, regarding both safety and efficacy. This phase of testing will last several months to two years.

Phase 3 – Large-Scale Testing. In this phase of testing, the research group is expanded to include up to several thousand members. This allows both the researchers and the FDA to monitor the efficacy and safety of the drug on a much larger scale and to gain a much better general knowledge of the drug itself and it’s effects. This phase is considered highly important not only for it’s providing a much broader and more effective test range, but that a drug that successfully completes this phase can be brought to the FDA for approval for marketing. This phase of testing can typically last several years.

Phase 4 – Post Marketing Surveillance Trials. At this point the pharmaceutical companies monitor the drug as it is available for the consumer market. In this period, the drug will continue to be tested in efficacy and safety, but in a broader, long-term fashion. At this point the drug may be removed from the market for various reasons (efficiency, cost-effectiveness, etc) or compared to new or current drugs to weigh whether or not it is needed. Also, restrictions may be placed on the drug at this time is warranted.

What are the Observational Studies of a Clinical Trial?

Observational studies are those conducted on a group or individual to infer the effects of a particular study. In clinical trials, the observational studies are conducted by the researchers and the FDA to monitor the effects and risks of a drug in its clinical trial phase. Individuals and groups will be assessed and monitored throughout the process in order to ascertain results, but also see to the safety and well-being of the trial members while they partake in the study.

All in all, clinical studies are an effective and proven way to deliver an effective and profitable new product to the market. It not only ensures the safety of its users, but also leads to an informed public on all benefits and any side-effects that may come with it.

www.wikipedia.org – Clinical Trials Information