A clinical trial report is an overview of the data identified in a clinical trial. These reports are normally published in medical journals for evaluation, and to serve as the basis of continued experimentation by other health professionals. A clinical trial report may also be submitted to the Food and Drug Administration (FDA) in an attempt to get approval for a new drug.
When a new medicine or treatment is invented, it must be tested before it can be widely administered to the public. Most drugs and medicine first undergo extensive testing in animals to determine whether the substance is safe or effective. Eventually, however, it becomes necessary to try out the treatment on people.
When a drug or treatment is tried out on people, this is called a clinical trial. Patients volunteer for clinical trials either for compensation, or to receive potentially life saving experimental treatment for diseases. Those who are conducting the clinical trial must obtain informed consent from all patients involved.
When a clinical trial takes place, patients are given the new drug or treatment being tested. In some clinical trials, another group of people involved in the trial are given a placebo instead, so they can act as a control group to compare the drugs performance against. The people involved generally do not know whether they are given the real treatment or the placebo.
During the clinical trial, extensive reporting is done. The patients usually undergo many medical exams. The exams evaluate the effectiveness of the treatment and any potential side effects that occur.
The patients response to treatment is meticulously documented in a clinical trial report. The report uses test results to demonstrate whether the drug is effective. The clinical trial report is normally extremely specific about how patients, as a group, respond to the drug treatment.
The clinical trial report then summarizes the results. It explains how many patients improved as a result of the treatment, and by how much. It also explains how many patients experienced side effects, and what the range of those side effects was.
The clinical trial report is normally prepared by the physician, or group of physicians, who conducted the clinical trial. It is then submitted for publication and/or to the FDA. The report normally undergoes intense scrutiny from other doctors to determine whether the clinical trial met rigorous testing standards, and whether the results can be reproduced in other trials.
Before a drug is approved by the FDA, many clinical trials usually take place. An aggregate of the reports from all these trials is looked at to determine whether a treatment is safe. In this way, people are protected from drugs that cause obvious problems, or that are obviously ineffective.
