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The value of patient reported outcomes

By Su Smith

Su Smith

The journey towards true patient-centricity

The patient voice is now at the centre of drug development. As with any journey, there has been more than one route to the destination. The expression ‘no decision about me, without me’ came from the idea that to ensure patient voice inclusion, information needed to be shared in ways that patients would understand, so they could help make those informed decisions. Recently the major pharmaceutical regulatory bodies have strengthened their positioning in demanding patient-focused drug development.

Patients need to be involved at every stage, not just as subjects in clinical trials, but as the experts of their own condition. In the same way that the doctors are the intellectual and medical experts on a condition, the patient is the one with the lived experience. The regulatory bodies are therefore now requiring evidence of the collaboration with patients in drug development. This applies to both patient input into the design of the clinical trials as well as their input into what the practicalities of that condition mean on a more qualitative level.

Today, new products currently in clinical development are in a different space, in that they are required to be patient-centric. There is still a lot of education required for the pharmaceutical industry to understand what it means to be truly patient-centric.

Understanding the patient’s objective
The drivers for drug development have long been focused on what doctors believe is a good treatment and what will make a clinical difference to patients, while being cost-effective. However, patients may have their own objectives. With a condition like psoriasis, for example, a physician’s clinical objectives don’t always take into account the intense itch and burn that the condition brings – experiences that patients have reported as the most important aspects to them. This is where taking a patient- centric approach can add value. What are the benefits of the drug to the patient that go beyond what the clinician or the payer is trying to achieve from a cost perspective?

Where the real value comes in
Patient-reported outcomes are formal measures that, as the name suggests, are reported by the patient without interpretation by a clinician. We need to know what the patient said or felt, and the data they entered – we want the uncoloured version. Patient-reported outcomes play a key role in the inclusion of patient voice in patient-focused drug development.

How patient data is captured
Patient-reported outcomes need to be quantifiable so that there is no ambiguity – rating scales and event counts are good examples of these. At Origins we have completed many qualitative insights projects that explore the patient voice, and where possible we included patient-reported outcomes as an element of the project to give deeper meaning and context to the insights. Examples have included pain scales and seizure counts. There are some challenges associated with patient-reported outcomes. These are mainly linked to the patient’s understanding of how to complete the information and the additional burden that capturing these data may add to a patient’s life. Sometimes patient- reported outcomes and patient voice are used interchangeably or mixed up. There is a place for both, but the purity of patient-reported outcomes as data shouldn’t be confused with the qualitative depth of information that you can get from the inclusion of the patient voice.

The strategic advantages
At Origins we are clear about the distinction between patient voice and patient-reported outcomes. There is also a strategic element to consider. As well as the importance of the data to the patient, there are the insights and the solutions it offers, and how that can then give pharmaceutical companies better outcomes in terms of getting their drugs to market. Modern, relevant patient-reported outcomes will put companies in a strong position for patient-focused drug development. We believe that it’s a part of end-to-end patient strategy. From the moment the decision is made, that ‘yes, we are going to develop a drug in this therapy area’, that is the moment you should employ your patient-centric strategy.

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Su Smith is Director at Origins, part of the Resonant Group

15th September 2022

From: Marketing, Healthcare


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