Clinical trial data management refers to compiling all of the data and evidence collected in a clinical trial. Clinical trial data management is an essential component of the clinical trials performed by drug companies, research and development groups and universities. The data from clinical trials is used to help new drugs and treatment protocols obtain approval from the governing body that determines whether drugs are safe.
A clinical trial refers to a test. Normally, clinical trials refer to tests of new drugs, or the testing of existing drugs for new uses. Clinical trials can also take place to test the effectiveness of a new treatment protocol.
During most clinical trials, two groups of participants are selected. The first group receives either a placebo, which means a sugar pill or non-treatment, and the second group receives a new type of drug. In other clinical trials, such as those testing new treatment protocols for dangerous or fatal diseases, all participants in the trial receive the treatment protocol being tested.
The participants in the clinical trial undergo routine and frequent examinations to determine the effectiveness of the treatment they are testing. These examinations seek to determine whether the treatment is effective at resolving the illness or problem the drug or method is designed to treat. The examinations also seek to identify any potential side effects or risks of the treatment.
All of the data collected from the examinations is kept and managed under the clinical trial data management system. Often, those administering the testing and exams do not know which patients are receiving the actual treatment and which are receiving the placebo. This is called a blind clinical trial, although double blind and triple blind clinical trials also exist in which added layers of secrecy are put in place to ensure that those conducting the trial do not know which participants are receiving the therapy and which are not.
At the end of the clinical trial, the individuals in charge of clinical trial data management compile all the data to determine whether the therapy proved effective. The results of the treatment and the potential side effects are compared to the placebo group and/or to existing and established methods of treatment to determine whether the new treatment method being tested performed appropriately.
Often, numerous clinical trials are performed on a single drug or substance to ensure its safety and effectiveness before the drug is released on the market. Clinical trial data management can involve compiling all these results. The results are then submitted to attempt to gain approval for the drug; for example, in the United States, the results are submitted to the Food and Drug Administration (FDA) which is vested with the responsibility of approving new drug therapies.