Phase i Clinical Trials

Phase i trials and clinical research. In medical research studies a phase 1 clinical trial are the first step in human trials of a drug. These trials are important not only for gathering information about how a drug works on a human subject but also for confirming the effectiveness of a preclinical trial at measuring the safety of a certain drug or procedure. In a standard phase 1 clinical trial in medical research a group of human participants that is no bigger than 100 volunteers to be part of the trial and the participants are often chosen at random from this pool of people. The phase 1 trial is designed to test the safety of a drug on humans as well as the amount that a human can tolerate. Pharmacokinetics, pharmacodynamics and benefits of a drug are also tested during this process. Clinical trials such as these are often done at a place that is often an inpatient clinic and in this environment the staff of the clinic can monitor the participants of the study with little problem. This makes it easier for the results of the procedure to be recorded accurately as researchers do not have to rely on the participants description of a drug’s effects as a sole method of gathering data.

During a phase i study, dose ranging or dose regulation is an important feature. This practice seeks to gather information on what an appropriate dose of a certain medication should be in order to notice a benefit to the consumer. Drug companies use this feature of the clinical trial to gauge how much a dosage should be as well as how much the body reacts to a medication at different dosages. Often volunteers who are healthy and well participate for this procedure but in rare instances an actual patient may be used in the trial such as those with HIV or with some terminal disease other than this.