The biggest challenge for today’s digital, hybrid, and decentralized clinical trial (DCT) methods—speed

David Blackman, Executive Director Digital Trials Strategy

Years ago, sponsors and clinical research organizations (CROs) may not have thought of speed as a top priority for optimizing clinical trials. They were more likely to emphasize goals like reining in costs or streamlining the study startup process. Only the most innovative companies were shifting away from paper-based processes in favor of alternative approaches like eConsent that could speed certain processes for patients. Yet, overall, research and development were still happening at a slow crawl.

For some perspective:

  • Clinical trials take 6–7 years on average.
  • It takes an average of 10–15 years for a Phase I program to progress to regulatory approval at a cost of $2.6B.
  • Pharma companies get NO return on 86.2% of their R&D investments, and for the few drugs that make it to market, they may only have five years left on their patent before generic drugs are allowed to enter the market.

These timelines were normal until the COVID-19 pandemic hit and speed became critical. A vaccine was desperately needed, but the preceding clinical trial research—in fact, all clinical trial research—suddenly had to be performed remotely due to social distancing mandates.

Many sponsors and CROs implemented digital, hybrid, or decentralized clinical trial (DCT) methods to keep existing trials active or to enable new ones. To reduce cost and streamline trials further, some also moved from point solutions to “all-in-one” eClinical platforms. These changes proved that technology plays a critical role in ensuring speed is an attainable goal, further evolving market expectations going forward.

As a result, the clinical trial landscape is more competitive than ever, and leaders are demanding changes to reduce the time and cost required to bring life changing and saving treatments to patients faster.

Many sponsors and CROs that worked so hard to respond during the pandemic are finding that the solutions they now use can’t scale and aren’t interoperable enough to keep up.

The eClinical platforms that got them to this point really only patch together pre-selected solutions for study startup (SSU), electronic data capture (EDC), clinical trial management system (CTMS), and randomization and trial supply management (RTSM). Because these platforms aren’t truly interoperable, they are inefficient and inflexible with complex workflows between systems that can slow the speed of clinical trials.

It’s now imperative for leaders to rethink the viability of first-generation eClinical platforms and consider the benefits of fully interoperable, next-generation platforms that are built for speed.

Oracle Health Sciences Clinical One Cloud Service (Clinical One), a next-generation platform for conducting digital, hybrid, and decentralized clinical trials, has emerged as a leading solution for improving workflow efficiencies, increasing speed to market, broadening patient access, boosting engagement and diversity, and reducing clinical trial costs. Clinical One is fully unified by design, meaning it harmonizes data, streamlines workflow, and saves significant time from study startup to study closeout.

One platform, one build, one login, one place

With Clinical One, you can collect and manage all your data in one place, so you aren’t making duplicate data entries. And all technologies and tools needed to conduct a trial (EDC, RTMS, etc.) are truly unified through a single, centralized platform.

This approach enables organizations to use the technologies they're accustomed to while reducing the amount of time for setup across multiple solutions. The platform also empowers organizations to easily adopt new technologies as they’re released—such as wearables and patient apps—with no downtime for upgrades or study deployment and no data migrations, so sponsors and CROs don’t have to worry about reinventing the wheel.

If there was one positive thing that came out of the pandemic, it was the understanding that technology can help us get where we need to go when we embrace it. We also learned that we must prepare for the future at every step and not wait for a crisis to force change within the clinical trial market. Oracle Clinical One was built with future-change in mind, giving sponsors and CROs the confidence that they can evolve their solutions no matter what comes next while meeting current demands for speeding R&D now.