[Risk-sharing agreements: choice of study design and assessment criteria].
A new taxonomy of market entry agreements (MEA), also known as risk-sharing agreements, was built. It is no longer based on the conventional distinction between outcome performance and financial contracts, proposed by Carlson. Instead, it formulates a clear distinction between monitoring studies and evaluation or impact studies. The nature of the studies implemented within these two categories is fundamentally different: monitoring studies contribute to continuous program performance tracking against expected results and evaluation studies seek to identify the specific effect associated with the treatment while controlling for potential sources of selection bias. In accordance with this framework, differential study designs, indicators and financial clauses were proposed to reduce clinical, economic and budgetary uncertainty.
Réseau d'évaluation en économie de la santé (REES), 28, rue d'Assas, 75006 Paris, France. Electronic address: launois.reesfrance@wanadoo.fr.
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D020811:Biomedical Technology; D002965:Classification; D004345:Drug Industry / Q000191:economics; D012107:Research Design; D020414:Risk Sharing, Financial
Health technology assessment; Innovation; Medicine; Médicament; Médico-économie; Partage de risque; Performance; Price; Prix; Risk-sharing; Study design; Études; Évaluation