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:
“I think it is a wise course for laborers to unite to defend their interests.... I think the employer who declines to deal with organized labor and to recognize it as a proper element in the settlement of wage controversies is behind the times.... Of course, when organized labor permits itself to sympathize with violent methods or undue duress, it is not entitled to our sympathy.”
—William Howard Taft (1857–1930)
“We are lonesome animals. We spend all our life trying to be less lonesome. One of our ancient methods is to tell a story begging the listener to say—and to feel—”Yes, that’s the way it is, or at least that’s the way I feel it. You’re not as alone as you thought.””
—John Steinbeck (1902–1968)