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Unmet medical need: How patient perspectives drive meaningful innovation (Guest blog)

A restrictive definition of unmet need would limit researchers’ capacity to deliver what matters to patients.

Where does medical innovation come from? The answer is, always, that everything starts with patients’ unmet medical needs. The first step for researchers is to understand how any new therapy could address a problem that is not covered by existing treatments.

Unmet medical need can be understood in a restrictive way, limiting the definition to diseases for which there are no treatments at all. Alternatively, it can be viewed more holistically. For example, there may be some treatments in a given disease area, but these treatments do not address all symptoms that matter to patients. An unmet need remains.

José Luis Molinuevo, Vice President and Head of experimental medicine, Lundbeck 

Once a need is identified in the patient population, researchers begin a lengthy process of identifying a drug target that could bring benefits to patients. They develop a plan, design trials and determine how to measure any clinical benefit. At every step, patient input is vital. It takes time to develop therapies with the potential to address the needs of the patient population, without leaving any patient behind. That is why it is essential that clinical research programmes take place in a stable and predictable ecosystem. The definition of unmet medical need is an important component of the medical innovation environment.

Johannes Streffer, Senior Vice President, Global Clinical Development, Lundbeck

In some disease areas, despite the availability of medicines, high unmet need persists. To ensure a holistic view of these needs, patient experience should be a driving inspiration at every stage of clinical development and of the regulatory pathway. After all, patients are best placed to say what would improve their lives.

Magdalena Jayatissa, Vice President, Global Regulatory Strategy, Lundbeck

The best way to determine unmet need is to establish an integrated perspective, based on real-world evidence (RWE) combined with patient insights. This brings together the benefits of quantitative data with the qualitative evidence that only patients can offer. By incorporating the lived experiences of patients and carers, researchers can bring context and depth to data.

Agathe Le Lay, Vice President, Value Evidence and Patients Insights, Lundbeck

Restricting the definition of unmet need risks imposing limitations on the direction of research. That may hamper the prospects of developing innovation that matters to patients – changing the well-established approach that has delivered positive improvements over several decades.