By: Aman Khera, VP, Global Head of Regulatory Strategy
The industry moved at 1,000-miles-per-hour to implement digital solutions during the pandemic. Now, it’s time to pull back a little. We need to create a framework around the use of digital technologies in clinical research.
Regulatory agencies must lead the way with clear direction. At the same time, they must also work together with industry to ensure that the path we follow gives patients the data transparency and ownership they so urgently crave. We must move forward thoughtfully, with the same rigor expected in clinical trials.
While great digital tools exist to open data access and make studies more convenient, restoring patient trust requires more than merely transitioning from paper-based forms and processes (e.g., consent forms) to digital ones. Although certainly beneficial, I’d argue such tools don’t represent real innovation. Real innovation entails viewing digital technologies through the eyes of the patient, setting frameworks that break down silos in ways that ultimately offer transparency and put patients in control.
Others have also noticed “… a growing emphasis on the ethical, responsible and transparent use of AI and data science.” But as one author notes, “In order for the promise of digital health to be realized, companies will need to ensure their patients’ data is safe, secure and error-free.”
That’s where blockchain may prove helpful.
Blockchain is a digital technology concept designed to safeguard security and accuracy alongside interoperability. Although most people equate blockchain with Bitcoin or other cryptocurrencies, it is actually just an immutable record of transactions over time. Rather than residing in a single location, however, the data is duplicated across large networks. Consequently, the data is hard to hack or change.
As another author notes, “…the potential uses for blockchain are wide-ranging because it can diminish the role of intermediaries in the transfer of data and improve the security and cost of those transfers.” Thus, blockchain makes it easy to decentralize while preserving data integrity.
Blockchain could potentially advance clinical trials by simultaneously:
- creating interoperability
- keeping patient data private through various levels of permission
- enabling patients to both view and control their data.
Many sponsors currently find that decentralized clinical trials alone are not enough to engage patients if patients don’t trust the regulatory framework around them. Blockchain could help reassure patients that their interests are protected regardless of whether a study is centralized or decentralized.
Nevertheless, blockchain has limitations. For instance, it requires network access or the ability to sync with other nodes once back online. It must be set up correctly and transparently regarding what permissions are granted to whom. Who gets to see what information? How are patients guaranteed they can revoke access to their data at any time?
These are the kinds of challenges regulators will need to address as blockchain and other digital technologies become more ingrained in clinical trials and post-approval studies.
As a recent STAT article notes, “Even in this turbocharged environment, it is possible to innovate with rigor and integrity …”
Like intent, data should be purposeful. One-size-fits-all guidance around digital technologies will not suffice, as the data itself is not one-size-fits-all. I’m hopeful that digital technologies will play a significant role in rebuilding public trust. For that to happen, though, the regulatory framework around them must be rigorous, thoughtful, and laser-focused on our patients.