| Literature DB >> 23061776 |
Abstract
The methods used for regulatory decisions must facilitate three kinds of communication: (i) with individual experts who must translate their knowledge into usable form; (ii) among the experts whose pooled knowledge informs those choices; and (iii) between regulators and those affected by their choices. Decision-making methods vary in their reliance on expert judgement and computational methods and, hence, in their ability to meet the goals of sound decision making: breadth, depth, precision, neutrality, evaluability and transparency. An approach developed by the US FDA, the Benefit-Risk Framework, integrates judgement and computation, cognizant of their strengths and weaknesses. Its application both requires and facilitates good communication about risks and benefits.Mesh:
Substances:
Year: 2012 PMID: 23061776 DOI: 10.1007/bf03261986
Source DB: PubMed Journal: Drug Saf ISSN: 0114-5916 Impact factor: 5.606