Myths and Realities about Biosensors in Clinical Trials
It is about creating options through a strategic roadmap
Vaxa has conducted over 200 in-depth interviews throughout the clinical trials value chain including but not limited to large and small drug companies, CROs, sites, regulatory bodies in North America and Europe, and technology suppliers in CTMS, EDC and others.
A large majority believes deeply that biosensors can have a significant and positive impact and fundamentally change how clinical trials are conducted. At the same time, they also express an array of frustrations on why there hasn't been more progress in using biosensors in a real world setting.
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A large majority believes deeply that biosensors can have a significant and positive impact and fundamentally change how clinical trials are conducted. At the same time, they also express an array of frustrations on why there hasn't been more progress in using biosensors in a real world setting.
We consolidated this research into ??????????????????
Myth #1 - A singe biosensor solution is possible to meet the needs of clinical trials.
Many of the pharmaceutical companies have played with one or a couple of commercially available biosensors, testing them out in different forms.
Wearables or biosensors have advanced significantly in the last 3-5 years in terms of core technologies, form factor, measurements, and their value proposition--this is particularly true for consumer general health and wellness.
Although many of the major brands have created portfolio of products, a closer examination of those portfolios show they are based on consumer preferences like pricing and features not on technological differences. Stated differently, consumer brand are designed on a single technology strategy with variations on consumer sales attributes versus optimizing them for particular applications or measurements.
Wearables or biosensors have advanced significantly in the last 3-5 years in terms of core technologies, form factor, measurements, and their value proposition--this is particularly true for consumer general health and wellness.
Although many of the major brands have created portfolio of products, a closer examination of those portfolios show they are based on consumer preferences like pricing and features not on technological differences. Stated differently, consumer brand are designed on a single technology strategy with variations on consumer sales attributes versus optimizing them for particular applications or measurements.
Reality #1 - A one-size fits all consumer strategy will not work in clinical trials.
Given the complexities and variabilities of drug trials and human beings, no single device will be able to provide broad support for clinical research that optimizes the way data is collected for different diseases, therapies, and outcomes. It does not also mean that a different solution is needed for each therapeutic area, trial, or end point.
Looking across the wearables landscape, it becomes clear very quickly that the majority of devices offer close to the same features and functionalities, with a few exceptions where some devices getting regulatory approval. This does not mean that the core technologies of FDA cleared devices are any better or worst than the non-FDA ones.
and has not yet made the transition that the current wearable consumer designs is one that is can be used to create biosensors with capabilities optimized for specific conditions and end-points.
In other words, the consumer space has provided a stepping stone to transition from everyday consumer devices to those that are designed with a specific purpose in mind.
We should remember patients in clinical trials are same consumers who have likes and dislikes. That is why many of the consumer driven features such as design-for-usability is as important for clinical trials as it is for general population since the clinical trials research community appreciates that it is important to make patients want to use the devices to help increase outcomes.
The design for usability should not be underestimated as it is a key element that optimizes the data collection process because, for example, trying to measure heart rate readings from wrist worn devices is not as accurate as placing the device as close to the heart as possible.
Another element of design is optimizing the solution for specific purposes instead of designing devices for general appeal.
Looking across the wearables landscape, it becomes clear very quickly that the majority of devices offer close to the same features and functionalities, with a few exceptions where some devices getting regulatory approval. This does not mean that the core technologies of FDA cleared devices are any better or worst than the non-FDA ones.
and has not yet made the transition that the current wearable consumer designs is one that is can be used to create biosensors with capabilities optimized for specific conditions and end-points.
In other words, the consumer space has provided a stepping stone to transition from everyday consumer devices to those that are designed with a specific purpose in mind.
We should remember patients in clinical trials are same consumers who have likes and dislikes. That is why many of the consumer driven features such as design-for-usability is as important for clinical trials as it is for general population since the clinical trials research community appreciates that it is important to make patients want to use the devices to help increase outcomes.
The design for usability should not be underestimated as it is a key element that optimizes the data collection process because, for example, trying to measure heart rate readings from wrist worn devices is not as accurate as placing the device as close to the heart as possible.
Another element of design is optimizing the solution for specific purposes instead of designing devices for general appeal.
Contact us to learn more about how Vaxa strategic approach can assist you to create a differentiate strategy to use biosensors in clinical research.