How technology is enhancing DCTs
How wearable technologies are enhancing clinical trials
The success of clinical trials and drug development depends on the quality and quantity of data collected. Whereas in conventional trial setups the collection happens in the clinic, capturing only a snapshot of the patient’s health data (e.g. through an electrocardiogram), technology can help track the same data over large periods of time, capturing patterns that may be missed on-site, and paving the path towards new insights.
Conducting site visits through telemedicine
Telemedicine has existed as a premise for decades, but the pandemic accelerated its adoption in a dizzying manner. Paired with a loosening of regulatory barriers, in order to enable remote access to healthcare while preserving the safety of patients and healthcare workers, the use of telehealth spiked. In the first weeks of COVID-19, and as the US declared a state of emergency, the number of Medicare members using telehealth grew 120 times. The first quarter of 2020 saw a 50% increase in the number of telehealth visits compared to the same period in 2019 (Source: CDC).
The embrace of the adoption of technology has been remarkable. A report by McKinsey mentions that providers are seeing 50 to 175 times the number of patients via telehealth than they did before. More importantly, from 11% in 2019, 76% of patients are now interested in using telehealth moving forward.
Technology is no longer a barrier, but an opportunity for running clinical trials. As patients are becoming more open to the modernization of interactions that have to do with their health, the adoption of technology to do so has multiplied. A world in which participants can attend their site visits without leaving the comfort of their homes, while site staff can interact with more patients and collect more data without adding to their workload, is already beginning to take shape.
Collecting data using digital devices
The adoption of digital devices allows researchers to collect data at home that they would usually only be able to collect in clinics. Wearable devices contain a range of sensors that enable the frequent, and even continuous collection of physiological signals from trial participants, while requiring minimal input from them. The data collected by wearable tech can be transmitted via an internet connection to sites or a centralized database, and from there it can be accessed by CROs or sponsors.
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Devices can improve participation and retention by overcoming many of the burdens listed in this handbook, while also potentially providing more reliable data than what is often collected on-site. The most common version of wearable tech found in day-to-day life comes in the form of fitness trackers, but medical devices that resemble their consumer-friendly counterparts are beginning to emerge.
When evaluating wearable technologies for your trial, it is important to remember a few key factors that can help you make the best possible choice:
- Are there peer-reviewed papers and/or studies on clinicaltrials.gov that validate the specific technology? In addition, although this is not a requirement for use in clinical research, consider certifications by regulatory bodies like the FDA that can provide an additional layer of reliability.
- Beyond price, consider the overall return of investment of the devices: the longevity of key components (for example, battery lifecycle), the build quality, any potential maintenance costs, the type of support offered throughout the study.
- The overall usability of the device can be as important as its performance. Opt for devices that require removal as rarely as possible. Waterproof devices with extended battery lives, that are particularly comfortable to wear at night, can enhance data collection and offer truly round-the-clock data.
- Data is king. As part of your research, look for HIPAA and/or GDPR-compliant solutions, who offer transparency on data ownership and storage. In addition, how a device measures a data signal (e.g. the average of one minute, versus a snapshot taken once a minute), and the accuracy of the overall data against the endpoint it is used for, is a key factor for consideration.
Areas of consideration:
- Digital devices with the same sensors can still have different specifications
- Should you use the same device, or devices from the same manufacturer, across your trial?
- How can a smartphone requirement affect the participant experience?
Adopting digital endpoints & biomarkers for drug development
“For a new drug to be approved, the manufacturer must provide the FDA with substantial evidence that it has a clinically meaningful effect on patients. It does this by providing data on endpoints, like survival or a substantial reduction in a biomarker like LDL cholesterol or hemoglobin A1c. Digital endpoints are the newest type of endpoint. They are assessed using data captured by a sensor, typically outside of the clinic during activities of daily living.“
Source: STAT, Digital endpoints library can aid clinical trials for new medicines
https://www.statnews.com/2019/11/06/digital-endpoints-library-clinical-trials-drug-development/
The use of digital endpoints in clinical trials means adopting the data collected by digital devices as a method for validating the efficacy of a treatment.
Though some studies rely on activity trackers to measure energy expenditure and steps, other biometric data is starting to see an increase in the frequency of use. Heart rate, oxygen saturation, and even more specialized biomarkers can be developed to measure specific conditions, as long as sophisticated sensors are used in their development. Validated digital endpoints mean that existing data can be interpreted in new ways, without relying on patient input which can often be subjective. For example, at Empatica we created an FDA-cleared biomarker for the detection of tonic-clonic seizures, which can be used to test the efficacy of new treatments in trials and overcome the inaccuracies of seizure diaries. A recent study by VeraSci used Embrace2 to measure the deterioration in the cognitive health of patients with Alzheimer’s disease, finding high correlations with in-clinic measures.
Potential endpoints that can be collected using wearables may include:
- Sleep
- Galvanic skin response
- Physical activity
- Heart rate
- Respiration rate
- Seizures
- Blood pressure
- Oximetry
- Gait assessment
- Temperature
- Respiratory infections
Biomarker development is an ongoing journey. The non-profit Digital Medicine Society (DiME) is compiling a library of digital endpoints, showcasing the virtually infinite opportunities that exist within this field.