Digital biomarkers are an evolution of existing digital health wearables. In addition to providing valuable inputs for patient monitoring, they also offer a new way of collecting data for clinical trials. Digital biomarkers can be used in a variety of clinical trials including pre- and post-intervention studies. Though there are many digital biomarkers available, they used to be expensive, cumbersome and not portable. But everything has changed!
Clinical trials, the past, present and future
Digital biomarkers and digital health wearables revolutionize the clinical trial process. The question is, what does this mean for patient monitoring?
One of the most exciting new technologies for patients are wearable electronic devices that measure and monitor vital signs. These devices are often referred to as ‘wearables’ or ‘digital health trackers’.
The use of these wearable devices in clinical trial settings is still evolving, however there are a number of factors to consider before using a digital health tracker in a clinical trial setting. With so many variables that can affect the final outcome, it is important to account for all factors as they apply to your study:
- The characteristics of each participant: there likely will be differences in response to different versions of the product; one person might have a heart rate monitor that works better for them than another; different skin color might cause some variation in response; and so on.
- The time frame within which you will be collecting data: if you want your data collected over multiple weeks, there will likely also be differences between participants because of seasonality; some people may respond better to specific products at certain times during their menstrual cycle whereas others may not; and so on.
- The way you collect your data: different studies have come up with different methods for collecting physical data from wearable devices such as heart rate monitors, while other studies just use blood pressure monitors or blood tests to collect data. It is important to understand how those methods work before using them in clinical trials because it can affect how we interpret our results given their limitations (see below).
- How long the study lasts: it’s common practice to collect data over several months or even years
In addition, digital biomarkers are excellent tools for assessing patient motivation; evaluating compliance with treatment regimens; monitoring adherence with therapy; and evaluating quality of life (QOL) scores. There are also potential research applications such as measuring quality of life scores across time frames and across different populations including ethnic groups (e.g., African Americans), gender groups (e.g., women vs men)…
Challenges with current clinical trials
Clinitian trials are a standardized process used to collect patient data before, during and after treatment. Digital biomarkers are objective measures of disease states collected digitally. They can be used to validate the effectiveness of drugs in clinical trials, as well as identify different disease entities among patients.
There are a growing number of digital biomarkers now available for clinical trials use, some of which have been designed and developed by the pharmaceutical industry. However, many clinical trial participants will not have access to or may not view these “digital biomarkers” from the perspective of the trial itself. Some will simply not want them, and others may feel embarrassed because they do not want to be labeled as having a particular condition or conditionally being labeled as having a particular condition that they may or may not have at all.
Digital biomarkers are objectively quantifiable measures related to a clinical outcome, captured digitally. Digital biomarkers can be used to monitor and track health over time, enabling researchers to assess and compare patient outcomes across different clinical trials.
The value of digital biomarkers is in their ability to track patient health indicators over time because they allow for objective assessment of the effectiveness of treatments and interventions. Such measurements are not only useful for monitoring treatment and prevention, but for tracking overall health.
Digital health wearables enable patients to monitor their own medical conditions using wearable devices that do not preclude normal daily activities.Within this context, digital biomarkers provide new insight into the improvements that can be made in the lives of people who have a chronic illness or disease (e.g., diabetes).
A study was recently published by researchers from Harvard Medical School in collaboration with Boston Children’s Hospital, who found that electronic devices worn by patients during clinical trials can yield important insights into clinical outcomes. The study analyzed data from 8,927 individuals participating in 9 clinical trials with ground-breaking results on how electronic devices affect the outcome of these trials as well as how they impact the study design itself.
The application of Wearable Medication Monitors (WMM) to clinical trials is advancing at a fast pace, particularly in Europe where regulators require large-scale studies with WMM use as part of their safety reviews for new drugs and biologics before they can be approved for marketing by regulatory authorities.
The introduction of wearables has changed many aspects of the way we approach health research: For example data collection is now much more systematic than it used to be thanks to wearables such as smartphones and wristbands; new data collection methods like Gastric Emptying Questionnaires (GEQ) are now available; and applications such as social networks have given us real-time feedback about our health status – from our smartphone apps – which is often more accurate than other kinds of feedback like heart rate monitors or ECG monitors which are more traditional ways we measure our heart rate.
So it should come as no surprise that there have been many recent advances in wearable technology in this field too: For example companies such as Apple recently announced its plans to incorporate glucose monitoring into its HealthKit app on iOS 9 which will work alongside existing mobile analytical apps such as MyFitnessPal…which will make it possible for users to record their food intake on their Apple Watch so that they can take an average of the nutritional values.
Looking to the future
Digital biomarkers are important for the quality and safety of patient care, but they are just one piece of the puzzle. They can also be used to improve the quality and efficiency of clinical trials by enabling researchers to gather more data on a variety of variables.
This requires some effort and planning in order to achieve this goal. One approach is to use digital biomarkers as a starting point in testing alternative treatments or interventions that may have positive effects on patients’ symptoms. Digital biomarkers can also be used to help with cost-effectiveness analyses, which is a critical part of clinical trials because it allows researchers to estimate how much it would cost to perform trials in different settings.
Once you have your digital biomarker, you need a research study that will allow you to collect data from various groups (patients, clinicians, etc.). A large number of small studies done by different groups on different populations can help determine how well digital biomarkers work for your product/service.
Digital biomarkers are a set of commonly used measurements (e.g. blood glucose, blood pressure) that can be used to monitor the physiological activity of the body and can even be used to detect diseases and conditions associated with the body (e.g. diabetes). Digital health wearables, on the other hand, consist of wearable devices that constantly collect data related to the user’s health status, as well as allow for a more personalized approach to management and treatment (e.g. a heart rate monitor).The potential benefits for medical professionals include improved patient care and communication with patients, as well as increased accuracy in diagnosis of diseases and conditions associated with the body (e.g. diabetes).
However, digital health wearables have some major limitations: The devices are not always accurate; They are often very expensive; They have much higher data requirements than that required for digital biomarkers; They require constant monitoring; And they are very sensitive to what is considered “normal” or “ideal” behavior for their users.
Digital Biomarkers, Wearables or Both for Clinical Trials? What do you think?
I was inspired to write this article after my conversation with Kate Lyden – Chief Science Officer at VivoSense. A very innovative and futuristic topic in health, life sciences and pharma. Certainly, the work that VivoSense is doing is extremely impactful and industry groundbreaking change.
Watch Episode #62 of Digital Health & Wearables Series:
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