Post Market Studies
Post Market studies are any means of obtaining information about a product after it has been approved for public use. Section 505(o)(3) authorizes FDA to require certain post market studies and clinical trials for prescription drugs approved under section 505(b) and biological products approved under section 351. Primary objective of Post market studies is to develop information about drug effects under routine condition of drug use. These post market studies are vital to enhancing patient safety and public health. Benefits of Post market studies include verification of risk analysis, chronic complication and performance trends.
Post market studies helps to detect rare adverse drug reactions, drug interactions and new uses of Drug. The results from completed post-market studies provide additional information that can lead to safety labeling changes, support expanded use of a drug, or alleviate concerns about a potential drug. Sources of post market information includes customer surveys, customer complaints and literature review
Method of post market Surveillance include:
- Controlled Clinical trials – Directly monitor patients for the duration of studies for evaluating a drug’s efficacy and safety
- Spontaneous or voluntary recording – A communication from an individual such as health care workers. This describes a suspected adverse event(S)
- Cohort Studies – Studies follow a defined group of patients for a period of time
- Case Control Studies – Case control studies identify patient with the adverse effects to be studied, and compare them with the sample drawn from the same cohort that gave rise to cases
There are two types of post-approval studies.
- The post-marketing requirements (PMRs) – use to assess a known serious risk related to the use of the drug, to assess signals of serious risk related to the use of the drug, and/or to identify an unexpected serious risk when available data indicate the potential for a serious risk
- The post-marketing commitments (PMCs) – These studies are commitments by the drug manufacturer to conduct post-approval studies to provide additional information on the drug. For example, a sponsor may conduct a PMC to examine the natural history of a disease, or to evaluate the efficacy of a drug in a subpopulation of patients