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Looking at the road ahead to properly utilizing digital technology in clinical trials.
Technology can be used either for or against the good of society. In drug development, ensuring digital technology delivers for good requires protecting patients throughout the clinical trial journey.
Too often, high-profile “bad apple” incidents such as the Theranos scandal—or the highly politicized environment surrounding COVID-19—have fueled public mistrust of the medical-innovation establishment. Now, rebuilding public trust is essential.
Digital technologies can help re-establish trust in drug development processes by breaking down traditional silos and enabling secure sharing of the right data, with the right people, at the right times. But digital technologies alone will never be enough. It’s not the data itself, but how we use it that either builds or breaks patients’ trust.
We cannot ignore the significance of the human touch, which is why a “patient empowerment” dynamic promises to shape the way the industry adopts and regulates digital technologies going forward.
Americans today are hungry for honesty and transparency; the industry must step up. Although healthcare data privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) are well-intentioned, many are showing their age. Regulations need to catch up with new data mechanisms and safeguards if we hope to recapture patients’ confidence.
Agencies like US Food and Drug Administration (FDA) appear willing to lead the way. Its newly appointed top official’s experience with research, regulation, and big tech may signal a new openness to a thoughtful approach to digital technology—one that ensures patients ultimately benefit from regulatory guardrails.
Whether it happens quietly or explosively, I believe the patient voice will grow in its influence and impact on digital technology regulations. Regulatory agencies are beginning to understand that a delicate, constantly changing balance must be struck between the technologies that can facilitate much-desired clinical trial transparency and the human-to-human interactions that truly build trust.
Patients must always form the fulcrum of that balance. Hence, we might expect the future regulatory landscape to be a little like riding a seesaw. We must be prepared to continually self-correct as necessary to reach a patient-focused equilibrium. Theoretically, at least, digital technologies such as blockchain can help bring about that equilibrium.
Patients want transparency, yes. But, even more than that, they crave ownership of their health data. Regulators need to address head-on the idea that a person and their health data cannot be separated.
Using digital technologies to give patients ownership of their health data—including the ability to revoke access to it at any time—represents true innovation. It grants patients bona fide power for the first time, generating a degree of trust that’s simply not possible through privacy regulations alone.
Blockchain is one digital technology designed to ensure shared data is safe, secure, and accurate. In the context of clinical trials, it could foster data interoperability and privacy, and give patients coveted transparency and control over their data. Technologies like blockchain could help boost patients’ confidence in governance protections—even in decentralized trials.
Still, no digital technology is a panacea. Regulators must answer critical questions as technology becomes more integral to clinical research.
Here’s the challenge: Few regulatory agencies have deep digital technology expertise. It’s industry expertise that fuels innovation.
Therefore, I believe regulatory agencies will begin to partner with private industry more frequently. They must preserve firewalls to maintain impartiality, but the more regulators work alongside providers and tech companies, the more they can develop real-world digital technology guidance that boosts patients’ confidence.
It all comes back to this: Patients must be the fulcrum on which digital technologies and human interaction balance. More than ever, regulators and industry realize they must work together thoughtfully and rigorously to serve patients and earn their trust.
The path forward will not be simple. Much work is needed to ensure digital technologies are used for good—but we’re already rolling up our sleeves.
Aman Khera, VP, Global Head of Regulatory Strategy, Worldwide Clinical Trials