Methods
The success of the RADAR program has previously been largely based on the use of diverse data sources to identify, clarify, and verify ADRs. Databases, registries, clinical trials, referral centers, and case reports have all been utilized as sites of detection. In particular, RADAR has made use of reports submitted to MedWatch as well as more focused databases such as the Medicare-SEER database. Hypothesis-driven active surveillance of a few hundred safety reports serves as the underlying conceptual framework of RADAR pharmacovigilance. Fewer than 20 individual ADR reports led to RADAR investigators identifying safety signals for the majority of the ADRs described to date. Despite a small number of reports for each ADR, causality assessments have been supported by pathology studies, antibody studies, and autopsies. For example, the initial description of thrombotic thrombocytopenic purpura associated with clopidogrel included only 11 cases.
Read more about this topic: Research On Adverse Drug Events And Reports
Famous quotes containing the word methods:
“In inner-party politics, these methods lead, as we shall yet see, to this: the party organization substitutes itself for the party, the central committee substitutes itself for the organization, and, finally, a “dictator” substitutes himself for the central committee.”
—Leon Trotsky (1879–1940)
“If you want to know the taste of a pear, you must change the pear by eating it yourself.... If you want to know the theory and methods of revolution, you must take part in revolution. All genuine knowledge originates in direct experience.”
—Mao Zedong (1893–1976)
“The methods by which a trade union can alone act, are necessarily destructive; its organization is necessarily tyrannical.”
—Henry George (1839–1897)