Clinical trials are a critical element in bringing new drugs to the market, and successful trials can bring hope to people in need of treatment. Unfortunately, when the COVID‑19 pandemic took hold in the US, it caused a major disruption in non-COVID‑19 vaccine trials that were planned or ongoing.
The result is an impact on healthcare and research spaces that are often taken for granted. There have been stories of medical studies that have been disrupted because doctors were no longer available, broken healthcare supply chains, and difficulty accessing medical tools and research.
With patients’ lives on the line, the pharmaceutical industry and regulatory agencies rapidly adapted to modern digital tools that helped empower frontline workers and patients to continue the work of healthcare in the new normal of COVID‑19.
Adjusting to change with modern technology
In March 2020, the FDA issued guidance to help the clinical trial ecosystem navigate the choppy waters of doing work in the time of COVID‑19. For innovative technology companies such as Signant Health, these new guidelines opened the door for fresh ways to accomplish traditional tasks in the new normal without compromising participant safety. The most dramatic change was that many trials had to be redesigned to support remote participants (a.k.a. decentralized clinical trials).
It may sound like a simple change, but there’s a ripple effect. Technology has played a major role in allowing for this transformation to be possible, including providing:
- Virtual meetings to support ongoing patient visits.
- Medical sensors and IoT devices to monitor patients’ health.
- Intelligent digital outreach to ensure patients were engaged.
- Low-touch/no-touch approaches to securely manage devices and data.
- Dynamic and agile methods to route clinical supplies directly to participants.
Fortunately, the underlying technology needed for these changes is commonplace. In fact, if you recently did a video call, used a fitness tracker, or ordered a product online, you essentially touched all the necessary elements. In the clinical trial space, however, patient safety, regulations, and privacy are front and center, and the challenge is significantly harder.
Microsoft Cloud for Healthcare has played a role in empowering our partners and customers to successfully overcome that challenge.
The new normal of decentralized clinical trials
We now know that decentralized (or hybrid) clinical trials can be successfully implemented at scale. Will this knowledge change how research and treatment are undertaken in the future? There are significant benefits to this new approach that may not be so obvious at first. The virtual nature of remote trials and treatment allows for a more natural, ethnically diverse, geographically distributed, and broader socioeconomic body of participants. There are also operational and cost benefits that may allow for a broader exploration of treatments for rare conditions that don’t typically get the attention needed. These challenges aren’t addressed as well as they should be in traditional clinical trials.
Although this evolution was forced and happened quickly, the promise of mass decentralized clinical trials has been discussed for decades. Yes, there were challenges with implementations over the last year, but the human spirit and intellect persevered. One silver lining of the pandemic is that it has united regulators, pharmaceutical companies, and the technology industry in an unprecedented way. We need more of this unification going forward. Let’s continue this evolution, bringing additional treatments to market and giving more people hope.