The costs of drug R&D are rising. The ongoing COVID-19 has been a catalyst towards digitisation for many companies. Simultaneously, advances in digital technologies has increased the amount of data being generated, particularly outside of a clinical setting. Here, we summarise a recent article that explored digital endpoints and the efforts that must be applied before the true benefits can be realised.
A digital endpoint is a new classification defined by an endpoint’s use of sensor-generated data, often collected outside of a clinical setting. These sensors exist in an array of different devices that can be applied in a diverse set of contexts. For example, smartwatches can be used to a measure a drug’s effect on the nocturnal activity of patients with sickle cell disease.
Digital endpoints have garnered a lot of interest as they enable a more authentic and objective assessment of the patient’s experience and can cut drug discovery costs in half. The ubiquity of relatively inexpensive sensors has positioned digital endpoints as key in changing drug discovery. Nonetheless, for their benefits to be fully exploited, efforts must be applied to the technical creation of these endpoints and the environment that allows for their development and applications.
The benefits of digital endpoints
Traditional endpoints have several deficiencies. Clinical evaluation often involves patients visiting the clinic, meaning data arrives in a series of snapshots. This does not provide insight into a patient’s daily burden. This is particularly problematic for diseases with persistent and limiting symptoms.
To be considered clinically meaningful by the FDA, an endpoint must directly measure how a patient feels, functions or survives. The only way to obtain a genuine representation of this requires the context of a patient’s typical day. By continuously collecting data, sensors and other technology enable this sort of analysis. As a result, digital endpoints can offer previously unavailable insights about disease.
Barriers to adopting
Although the enthusiasm for digital endpoints has increased, their use is not frequently applied. Here are just some of the reasons why:
- Disjointed efforts: Despite a unified vision on applying digital tools to healthcare, little international cooperation exists. Continued international participation will be important to accelerate the acceptance of digital endpoints. Additionally, interdisciplinary participation will be necessary for the successful development of these endpoints.
- Unproven value: Because digital endpoints have been applied so sparsely their potential remains hypothetical. Given the high costs of clinical trial failure, pharmaceutical companies are cautious to significantly reshape their drug discovery processes.
- Nature of healthcare data: Healthcare data has become difficult to manage, interpret and reuse, hence the development of the FAIR principles. The implications of adhering to these principles in the context of digital tools must be considered.
There is universal optimism about the use of digital endpoints within healthcare to help combat the cost of therapeutic discovery. They can help offer a more accurate and authentic portrayal of disease burden. Nonetheless, the broad adoption of digital endpoints will require a unified effort and sufficient evidence to realise their full promise.
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