CRACOWSKI, Jean-Luc; MOLIMARD, Mathieu; RICHARD, Vincent; ROUSTIT, Matthieu; KHOURI, Charles

doi:10.1080/14740338.2024.2368811

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CRACOWSKI, Jean-Luc

MOLIMARD, Mathieu

Bordeaux population health [BPH]

RICHARD, Vincent

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Expert Opinion on Drug Safety. 2024-08-01, vol. 23, n° 8, p. 959-967

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INTRODUCTION: Drug efficacy and effectiveness are assessed respectively through clinical trials and pharmaco-epidemiological studies. However, relative and absolute benefits of drugs are distinct measures that must be considered in relation to the baseline risk of disease incidence, complication or progression. On the other hand, adverse drug reactions are independent of the basic risk but depend on the characteristics of the population treated. Given these prerequisites, how can we balance the benefits and risks of drugs? AREAS COVERED: We use the example of therapeutics evaluated during Covid to describe how assessing the benefit-risk balance of drugs is a complex process. EXPERT OPINION: Clinical trials are not designed to identify rare adverse events, underscoring the necessity for a pharmacovigilance system. Evaluating the balance between the benefits and risks of drugs is an ongoing process, demanding the simultaneous analysis of data from clinical trials, potential drug-drug interactions, pharmacovigilance monitoring and pharmaco-epidemiological studies, to identify potential safety concerns. In addition, pharmacologists must play a major role in educating the general public about drugs, aiding in the accurate interpretation of the benefit-risk balance and preventing misinformation.< Réduire

Mots clés en anglais

Benefit-Risk Assessment

Covid

Drug Adverse Reaction

Drug-Drug Interaction

Effectiveness

Efficacy

Pharmacology

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Assessing the benefit-risk balance of drugs. Some lessons from the COVID pandemic

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