Academic Clinical Trials and Data Management-A New Era in Pharmacy
Although there are many definitions of clinical trial, they are generally considered to be biomedical or health related research studies in human beings that follow a pre-defined protocol. Clinical trials include both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured by the investigators. Clinical trials are conducted in phases. In Phase I clinical trials, researchers tests a new drug or treatment in a small group of people [20-80] for the first time to evaluate its safety, determine a safe dosage range and identify side effects In Phase II clinical trial, the study drug or treatment is given to a larger group of people [100-300] to see if it is effective. And to further evaluate its safety. In Phase III studies, the study drug or treatment is given to large groups of people [1000-3000] to confirm its Effectiveness, Monitor side effects, Compare it to commonly used treatments and Collect information that will allow the drug or treatment to be used safely. In Phase IV trials, post marketing studies delineate Additional information including the drugs risks, benefits and optimal use. A protocol is a study plan on which all the clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trials; the schedule of tests, procedures, medications dosages and length of the study. A clinical data management system or CDMS is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry. The most popular method being double data entry.
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