Using digital health to reimagine clinical trials

Traditional clinical trials are time-tested, but they are not location- flexible or cost-effective. As new digital health tools have transformed the market, researchers and drug makers are adopting a different approach to clinical trials, helping to enable faster and cheaper solutions in a virtual, pandemic-influenced world.

Decentralized Trials
Decentralization is quickly becoming the new standard for clinical trials. Decentralized clinical trials (DCTs) are primarily completed through local healthcare providers or telemedicine. But new digital health tools offer a new level of connectivity that remove the physical constraints and engagement with participants of traditional methods.

While many trials are not yet fully decentralized, new drug trials that are deployed through digital health tools enable clinical trials to be shifted closer to the patient. This approach results in simplified trial procedures that don’t require as many in-person visits, saving time and money for all stakeholders, including the patient.

Features of DCT solutions often include electronic consent, remote patient monitoring, and electronic clinical outcome assessments. These allow pharma to maintain links to trial participants without requiring in-person visits, capture data in real-time, and make updates to programs while they’re underway. The investment in digital health for clinical trials also means less cost involved for researchers and participants, as much of the trials can be conducted with minimal interaction.

Real-world data
Clinical trials are a longstanding piece of the regulatory approval process for drugs, devices, and digital therapies. However, the time and cost to complete them is prohibitive, and the likelihood of regulatory approval is low. Managing these factors is especially important in an era where trial execution is more challenging due to restrictions from Covid-19. Real-world data provides a way to improve the design and execution of clinical trials, while also improving the likelihood of success.

The use of computers, mobile devices, and biosensors for healthcare purposes is rapidly accelerating the growth of health- related data. Real-world data (RWD) encompasses this data relating to the health status of patients as well as care delivery. RWD can be captured in a variety of sources, including EHRs, billing and claims, disease registries, patient-generated data (e.g., wearables), and data from mobile devices.

Medisafe captures patient data to support medication management, and works closely with pharma to deploy drug-based clinical trials where data is captured through the Medisafe app. This approach enables better design and execution of clinical trials, as well as increase the odds of regulatory approval by supplementing clinical trial data.

In 2021, the FDA updated its guidance around regulatory bodies to incorporate new digital approaches to capturing real-world data. Now new data sources, data standards, and regulatory considerations are extended to new digital health tools, helping to capture more real- world data from patients in real-world settings to better support drug development and deployment tactics.

As a result, data has become a service, with most RWD companies offering SaaS platforms. This way, pharmaceutical companies can access the specific data they need, when they need it. Real-world data companies are taking this a step further by aggregating data from disparate sources and selling the data, along with software to generate insights, to pharmaceutical companies.

Looking ahead
The clinical trials of the future will be faster and cheaper, while continuing to become more representative of diverse patient populations. By incorporating more digital health devices, clinical trials will go beyond the traditional in-person approach and move toward decentralization, at-home services, and even simulated patient populations.

Equipped with AI-driven models, interoperable patient data, and remote monitoring technology, clinical trial improvements will bring down the overall costs and time requirements for drug development. Digital health again reigns supreme in the healthcare industry, this time helping to reimagine the role of clinical trials, with lower cost, greater scale, and better insights to develop better treatments for the future.

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