What Attributes to Digital Health Improving Clinical Trials?

What Attributes to Digital Health Improving Clinical Trials?

By Pharma Tech Outlook | Thursday, October 24, 2019

Digital health in clinical trials is essential to create customized experiences and personalized therapies for patients.

FREMONT, CA: As addressing clinical issues gets complicated, digital health technologies eliminate the problems while reducing costs, errors, and repetitive manual tasks. This digital health technology will help improve the efficiency of clinical research in the clinical industry. Especially, technologies like big data, predictive analytics, sensors, wearables, and smartphones will have a high impact on increasing clinical trial efficiency along with the development of new drugs and health management therapies. Although there are many potential advantages, drug developers struggle to integrate mhealth and other digital health technologies into clinical trials. The challenges occur in terms of technical problems, internal organizational and cultural barriers, cost, and human resources. Drug developers usually address this by partnering with contract research organizations (CROs).

How digital health helps in improving clinical studies.

Big data can help identify potential trial participants and assist in designing mobile apps and web interfaces to streamline patient education, consent, and enrolment. It can reduce the need for patient visits through remote data collection apps, web-enabled scales, blood pressure tests, and blood sugar tests. It enables more remotely located patients to participate in clinical trials. The use of wearable sensors in clinical studies enables recording daily activities and sleep patterns and thereby evaluating them for monitoring vital signs such as heart rhythm and blood pressure. It provides granular information about disease states while detecting the diverse outcomes earlier. Thus the combined ability to utilize data from sensors and non-clinical data holds the potential to accelerate its utility in clinical research.

Moving forward, digital health technologies can transform the way of conducting clinical trials and generate customized therapies. Through machine-learning techniques, motion data can be tracked where a patient has opened his or her medicine bottle and also the person who has handled the dispenser based on the previous motion records. Such techniques improve compliance in trials while reducing uncertainty due to noncompliance with study protocols. Finally, combining data from historical trials and data from genomics, lab tests, drug prescriptions, and patient medical records data help find patients who are eligible for a trial. The potential of digital health technologies goes beyond transforming the trial design to generating customized therapies using biomarkers and targeted therapies for better patient outcomes.

The existing digital health trends applications are proliferating in clinical medicine than in clinical research because the commercial devices like pedometers and smartwatches are mainly used for encouraging and monitoring behavioral changes. In the future, as health systems realize the benefits of digital health, they widely adopt these technologies, and many forward-looking companies have started incorporating digital health through remote monitoring and the use of treatment apps. Further, AI-enabled technology, when used in devices, will take mHealth to the next level.

Needs for Successful Digital Health outcomes

Robust and Scalable Data Infrastructure

A digital platform that is scalable with an ability to absorb high-frequency data sets from a large number of data sources and present these data in a form that can be easily explored by data scientists is preferred by pharma enterprises.

Digital Biomarkers

It is essential to establish a relationship between physiological data and therapeutic and environmental measures to obtain insights and develop useful digital biomarkers. Therefore, using the expertise and working with regulatory agencies can develop useful digital biomarkers.

Selection of Device and Validation

The devices with the following capabilities should be selected:

• Acquire essential data

• Easy to use

• Easy to adapt to the changing conditions

• Connect to smartphones and other network devices quickly

Regulatory Compliance

Expertise in regulatory requirements and experience working with regulators in advance is necessary to approve new digital technologies and is critical for digital health development.

Because the clinical trials industry is lagging behind compared to the other sectors in digital evolution, it is necessary to incorporate digital health to thrive in the digital market.

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