Is trust the key success factor for decentralized clinical trials?
June 27, 2022
Clinical trials are a driving force of innovation in life sciences—without them, life-saving therapies and new discoveries wouldn’t happen. However, clinical trials are also costly and time-consuming. As a result, many companies are looking toward new models to accelerate the process and bring new, innovative therapies to patients. One of the most exciting areas of research today is in decentralized clinical trials (DCT), which have the potential to reach more people, gather more meaningful insights and improve health equity.
There are challenges when it comes to the adoption of DCT, as many patients are wary of sharing personal health data through digital channels. In order to solve for this, life sciences companies need to ensure that security and digital trust are embodied in the way DCTs are designed and executed.
The value of trust
Decentralized clinical trials apply digital technology to the clinical trial process, with innovations such as telemedicine, electronic questionnaires, wearables, electronic patient recorded outcomes and more. This drastically reduces the number of required site visits for patients. While this shift is part of a larger move towards remote medicine, DCTs are also instrumental in improving trial success and bringing new therapies to market.
A significant amount of traditional clinical trials are abandoned because they either are unable to attract sufficient participants or because they lose participants along the way. Our research has shown DCT can help solve for this in a number of ways:
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52%
improved patient recruitment
48%
improved patient retention
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40%
increase in speed of drug development
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It is also largely expected that DCT will also help improve health equity by increasing participation of minorities, who are still largely underrepresented. For example, according to FDA CDER data, 75% of participants in drug trials were white in 2020—yet the population demographics in the US have shifted significantly over the past decade. Between 2010 and 2020, the Hispanic or Latino population grew by 23%, while the multiracial population grew 276% in the same period1.
In order to increase DCT engagement, life sciences companies need to ensure that the data that is being collected is deeply protected—and digital platforms that enable data collection are persistently and securely available. With the rise of digital tools such as wearables, the amount of data that can be collected has expanded significantly, creating more dynamic data sets.
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In many ways, data is the new currency, and life sciences companies are starting to embrace it as such.
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Most participants in a DCT, however, remain concerned about what happens to their data—how it is protected and what it is used for. It is critical that we ensure that we only collect data that is necessary and protect that data throughout the life cycle to the point of it becoming irrelevant—and that patients have a clear understanding of data protection and have control over that privacy. For the tech that is being used, it’s also important to have a clear data protection strategy when building partnerships with suppliers, knowing what their risk level is and how they are protecting data. And all of that has to be communicated clearly and transparently to patients. If they trust in the data protection, they will trust in the trial.
Protection = Participation
Most companies will leverage a variety of partners to successfully enable DCT for their organization. In order to build trust, companies must establish protections for patients. Our research has identified four core levers for doing this:
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1
Establish a cyber third-party risk management program. Most DCT implementations have a wide array of vendors. It’s critical to gain visibility and mitigate risks to patient data within the ecosystem.
2
Implement suitable strategies to minimize, anonymize and protect data to give patients control over their health data and ensure privacy is protected through the data acquisition process.
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3
Modernize identity and access management systems that are used to manage patient and partner identities.
4
Define and embed an application security strategy to protect the apps used to enable DCT and pair it with a strong platform security strategy for the clinical trial platform and its data components.
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Taking clear steps to protect data and being transparent about these strategies will help improve trust in DCTs, thereby increasing participation and rendering improved trials results that will lead to innovative and breakthrough therapies for a broader population.
It all starts with data security and protection.
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