The Role of Post-Marketing Surveillance in Clinical Trial

Post-marketing investigations in clinical trials Clinical trials on new drugs can be divided into four phases (1). The drug development program usually goes through all stages within a few years (1). If the first three stages succeed, the medicine will be approved for use in the general population; I, II, and III. The fourth stage - IV - is called post-marketing survey and / or post-approval investigation (2). Surveillance test after marketing provides safety monitoring (drug warning) (3).

Since even the largest clinical trials do not effectively predict the prevalence of rare side effects, it is usually necessary to monitor after phase 4 approval. Due to surveillance after marketing, drug safety is closely monitored even after listing. In some cases it may be necessary to limit the indication to a specific patient group, but in other cases the substance is completely excluded from the market. In the UK, pharmaceutical and health product regulatory authorities have approved the use of pharmaceuticals, but the assessment was made by the European Medicines Agency (European Union based in London). Usually, the approval of the UK and other European countries is slower than in the United States. Then the British and Welsh National Health Management Excellence Institute (NICE) came. And how did they allow and allow the National Health Service (NHS) to use them (in terms of payment)?

Many of the letters published by BMJ refer to serious problems in pre-licensing clinical trials and short-term postmarketing surveillance that failed to detect vaccines. In order to show that the "rigorous examination" quoted by the European Parliament as evidence of vaccine safety is not "absolutely reliable", one author cited two examples. First, "the seriousness of the problem was not detected after postmarketing monitoring" (excessive risk of aseptic meningitis) has been introduced in the UK (and other countries) Urabe measles - mumps flu - It was associated with a rubella (MMR) vaccine. Delay in eliminating vaccines from markets in the 1980s and 1990s has hurt many people. Second, tens of thousands of children and adolescents developed narcolepsy after Pandemrix's "swine flu" vaccine was vaccinated between 2009 and 2010; safety signals in children's clinical trials and post-marketing trials Was not seen. But that is not the case. "