Rethinking the Investigator’s brochure
The investigator’s brochure (IB) has long functioned as the main reference document for clinical trials, providing investigators with information needed to understand possible risks or adverse events (AEs) related to the investigational product and keep sites up-to-date on the study. Yet IBs are invariably lengthy, complex documents that are seldom read cover-to-cover or consulted when questions arise. While new technology has impacted many clinical research domains to improve the usability and efficiency of documents or processes, IBs remain a relic of another era.
Transparency mandates reach new heights
In September 2016, the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) issued companion versions of a Final Rule that clarified and expanded transparency requirements in human research initially outlined in the 2007 Food and Drug Administration Amendments Act (FDAAA). The Final Rule weighed in on a longstanding debate about whether industry sponsors were breaking the law by failing to post trial results. Various interpretations of the 2007 FDAAA transparency requirements led to widespread criticism of industry-sponsors and NIH-funded researchers alike for failing to post trial results; meanwhile, sponsors took refuge in a more narrow interpretation of the statutory requirements
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