EU Framework For Patient Preference Studies Under Review
An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice approach to conducting patient preference studies.
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The International Council for Harmonisation wants to ensure that methods used to collect and integrate patient views into drug development and regulatory decision-making follow agreed standards.
More than a year after UK health technology assessment body NICE started offering scientific advice on designing patient preference studies, only two companies have sought guidance. NICE has also contributed to related projects that it hopes will increase the relevance of such studies in the context of an HTA appraisal.
The UK’s Early Access to Medicines Scheme continues to provide important flexibility, but companies also now have the option of a new ambitious pathway launched this year for accelerating time to market for innovative medicines.