The Clinical Trial Process: An Overview
A new drug has to pass through laboratory testing before it can be approved for clinical trials. A doctor selected as the principal investigator plans the clinical trials and a typical planning includes the incorporation of the reason for study, number of enrollments allowed, eligibility criteria of the participants, the drugs to be used and the medical tests that would be required from time to time and lastly, the information that is to be collected. Same protocol is followed by all medical centers under this trial irrespective of their locations. This uniformity ensures easy collection and comparison of information from these different centers.
Organizations and individuals searching for better treatments for Cancer opt for the clinical trials. Various clinical trial programs sponsored by the National Cancer Institute (NCI) include the Cancer Centers Program, the Cooperative Clinical Trials Programs and the Community Clinical Oncology Program (CCOP). With this program’s community focus, people would no longer have to travel long distances to the large cancer centers for participating in the trials. This is achieved by linking community physicians with the researchers in the large centers.
Safety is the focal point of the Phase I trials whereas the latter two phases examine the effectiveness of a drug. When a drug passes through these three phases successfully then only the FDA( Food and Drug Association) would permit the pharmaceutical company for the sales. After the first two phases, if the researchers feel that they can proceed to the Phase III then only comes the question of further experimentation otherwise the trials get stopped after the first two phases specially when any potential side effect was found in those phases. The results of the third phase are then submitted to the FDA for final approval. The FDA makes judgment on the basis of manufacturing process, the drug’s chemistry, and the side effects it produced during the trials. The aim of FDA is to allow the sale and use of those drugs which have an acceptable limit of side effects. It is out of this effort that Alimta, a drug has been approved to treat Mesothelioma patients who satisfy particular eligibility criteria.