Lokavant: A paradigm shift in clinical trial intelligence

Lokavant’s mission is to leverage predictive analytics to effectively plan and execute trials.

Published on: Apr 16 2021, 09:00 ET

Lokavant was launched by Roivant Sciences, a healthcare company focused on applying technology to drug development, just a few months prior to the U.S. shutdown order at the start of the COVID-19 pandemic. With limited access to trial sites during the shutdown, and as virtual trials continue to proliferate, Lokavant’s technology and capabilities—remote trial oversight, predictive risk monitoring, and data-driven trial planning—have become even more critical to ensure effective trial execution.

The pandemic has emphasized how much is at stake if the inefficient status quo in clinical development is maintained. If we are committed to bringing meaningful therapies to patients faster and cheaper, clinical operations must evolve to meet the needs of patients and stakeholders in today’s world.

Clinical trial operations are broken. Consider this: one in six trials fails today because of preventable quality issues—problems that have nothing to do with the safety or efficacy of a potential therapy. Many drugs that do go on to receive regulatory approval are marred by delayed timelines and budget overruns; indeed, the average cost to develop an approved drug has more than doubled to $2.6 billion over the last decade.

The enterprise consequences of these operational failures are tighter margins and a damaged bottom line for sponsors and CROs. Those who suffer most, however, are the patients who these companies seek to serve, who have access to fewer treatment options and are burdened by higher drug prices.

Why are today's clinical trials inefficient? Because data is grossly mismanaged across the industry:

Number of data points per late-stage study (Tufts CSDD)

Due to these challenges and inefficiencies, by the time trial data is aggregated in a way that is useful to understand, it is usually far too late to apply insights to a trial. Human analysis reveals errors days after they occur, at best, and often overlooks early indicators of risk in today’s increasingly complex studies. Current technological solutions do not offer much beyond static statistical monitoring, typically uncovering mission-critical errors related to trial startup, enrollment, follow-up visits, etc. some time after they have occurred and compounded. Teams are left chasing the source of issues rather than proactively identifying and mitigating them, resulting in additional costs and potentially detrimental delays.

Moreover, study designers and planners are often blind to the real-world impacts of study parameters, resulting in impractical study timelines and budgets. In the absence of systematically collected, aggregated, and analyzed data, trial operators often rely on data from a few recent studies or on outdated benchmarks of lookalike trials.

How does Lokavant address these challenges?

The best way to mitigate operational error in trials is to enable clinical teams to be proactive rather than reactive at every stage in the process. We envision a world where operators no longer have to respond to quality issues after they’ve surfaced, wasting critical time and resources on tedious and complex operational matters. That means reversing the paradigm so that the influx of data is no longer a burden for clinical operators, but instead enables teams to make informed decisions beginning at the trial’s planning phase—facilitating error-free execution all the way through study completion.

Here’s how we do it:

A sample Risk Assessment and Categorization Tool (RACT) template in Microsoft Excel (compare with Lokavant’s cloud-based dashboard below)

Lokavant Oversight application dashboard home page

We believe that these efforts will fundamentally transform the way that clinical trials are run. Powering actionable risk-mitigation insights as soon as the first patient enrolls in a trial, our industry-leading data repository and data standardization capabilities enable users to make evidence-backed decisions that prevent errors from occurring and compounding. We believe that this will:

In a rapidly evolving, tech-driven world, data mismanagement is a mounting barrier to efficient and effective clinical development. By combining the most rigorous data and analytics with existing human experience, Lokavant is enabling a world where no trial fails, is delayed, or is over budget because of preventable operational issues—to bring cheaper drugs to patients in need more quickly and efficiently. 

Are you a sponsor or CRO running a clinical trial? If so, we’d love to hear from you. Get in touch at contact@lokavant.com.

P.S. Want to join the mission? We are looking to expand the team with the best and brightest people who are passionate about fundamentally changing the way clinical trials are run.

Check out our open positions at https://www.lokavant.com/careers.