EMA draft patient preference guidance – deadline for input 25th November

European Medicines Agency (EMA) draft guidance on eliciting patient preferences

Patient preference studies are a growing topic of interest for many different stakeholders (e.g. regulatory bodies, payers, industry, and patient organisations) as they can help identify how patients assess the values of treatments or their attributes.

As a part of the European Medicines Agency (EMA) wishes to incorporate patients’ voices into drug development (ref. EMA Regulatory Science to 2025, Strategy Reflection), EMA’s Committee for Medicinal Products for Human Use & EUnetHTA has published a draft guidance, Qualification of a Framework & Points to consider for method selection with methods for performing patient preference studies to inform regulatory & HTA-body medical product decision-making.

Reminder: The deadline for providing comments to the Draft Qualification Opinion is the 25th of November.

The draft guidance aims to provide an initial set of tools, based on the systematic review of available evidence and the evidence generated by IMI PREFER. PREFER is a public-private collaborative research project under the Innovative Medicines Initiative (IMI) (see our previous article on Patient Preferences as Input to Medicinal Product Decision Making).

The draft guidance sets out PREFER’s framework and ‘Points to Consider’ for methods selection as a way of providing insight. It also gives suggestions on how patients’ perspectives could be measured through various patient preference studies and then incorporated into the regulatory approval process and also inform HTA and payer decision making.

These perspectives are at the heart of the Clinigma® mission; including finding out what matters to patients, how much it matters, the acceptability of trade-offs between benefits and harms, and the acceptability of uncertainty.

Clinigma® has provided input into the FDA’s Patient-Focused Drug Development (PFDD) guidelines and intends to be closely involved in the evolution of the EMA final guidance on capturing patient preference data in clinical trials in 2025. Clinigma® has already made a Standardised Interview Manual (SIM) that accommodates the draft guidelines and can operationalise the smooth integration of interviews – before, during, and after trials. This important EMA guidance is a part of our services, ensuring that the Clinigma® SIM is continuously updated in accordance with regulatory bodies.

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