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Benefit-risk assessment in used in various phases along the drug lifecycle, such as marketing authorisation and surveillance, health technology assessment (HTA) and clinical decisions, to understand whether, and for which patients, a drug has a favourable or more valuable profile with reference to one or more comparators. Such assessments are inherently preference-based as several clinical and non-clinical outcomes of varying importance might act as evaluation criteria, and decision makers must establish acceptable trade-offs between these outcomes. Different healthcare stakeholder perspectives such as those of the patients and healthcare professionals are key for informing benefit-risk trade-offs. However, the degree to which such preferences inform the decision is often unclear as formal preference-based evaluation frameworks are generally not used for regulatory decisions, and if used, rarely communicated in HTA decisions. We argue that for better decisions, as well as for reasons of transparency, preferences in benefit-risk decisions should more often be quantified and communicated explicitly. This article is protected by copyright. All rights reserved.
This article was published in the following journal.
Name: Clinical pharmacology and therapeutics
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The science concerned with the benefit and risk of drugs used in populations and the analysis of the outcomes of drug therapies. Pharmacoepidemiologic data come from both clinical trials and epidemiological studies with emphasis on methods for the detection and evaluation of drug-related adverse effects, assessment of risk vs benefit ratios in drug therapy, patterns of drug utilization, the cost-effectiveness of specific drugs, methodology of postmarketing surveillance, and the relation between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines. (Pharmacoepidemiol Drug Saf 1992;1(1); J Pharmacoepidemiol 1990;1(1))
Declarations by patients, made in advance of a situation in which they may be incompetent to decide about their own care, stating their treatment preferences or authorizing a third party to make decisions for them. (Bioethics Thesaurus)
Removal of a drug from the market due to the identification of an intrinsic property of the drug that results in a serious risk to public health.
Any system which allows payors to share some of the financial risk associated with a particular patient population with providers. Providers agree to adhere to fixed fee schedules in exchange for an increase in their payor base and a chance to benefit from cost containment measures. Common risk-sharing methods are prospective payment schedules (PROSPECTIVE PAYMENT SYSTEM), capitation (CAPITATION FEES), diagnosis-related fees (DIAGNOSIS-RELATED GROUPS), and pre-negotiated fees.
The practice of prescribing medications in a manner that poses more risk than benefit, particularly where safer alternatives exist.
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