Axial Therapeutics Harnessed Data to Optimize Burn in Phase 2 Clinical Trial: Transparency in Clinical Trial Management

The clinical trial industry is very often associated with inefficiencies and expensive operating costs. In fact, studies estimate that the average cost of developing and bringing a new drug to market can cost over $2 billion.

In a study by the Department of Health and Human Services about barriers to clinical trials, the major obstacles to conducting clinical trials in the United States were: high financial cost, the lengthy time frames, difficulties in recruitment and retention of participants, insufficiencies in the clinical research workforce, drug sponsor-imposed barriers; regulatory and administrative barriers, the disconnect between clinical research and medical care, and barriers related to the globalization of clinical research.

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‍Overview of Axial Therapeutics

As a scientific leader in the biological role of the microbiome and its impact on human health, Axial Therapeutics has had a decade of experience in research for neurological disease and disorders, specifically focused on the gut-brain axis.

This has helped Axial stand apart in harnessing expertise to identify new drug targets in the gut and develop novel small molecule therapeutics that have significant potential for improving symptoms and treating underlying disease.

In 2023, Axial was working on a Phase II clinical trial to treat irritability associated with autism spectrum disorder (ASD). While Axial was doing their best with the trial momentum, clinical trial recruitment was something of a “black box,” or lacking the necessary transparency, into which recruitment efforts were and were not working.

Like many other biotech companies, Axial was compiling a weekly recruitment and enrollment tracker spreadsheet for senior management and clinical operations to align on progress and maintain visibility, but this was manual, time-consuming, and lacked the capability to tie together all their data in real time from various systems, such as their study website, Electronic Data Capture (EDC), and Interactive Response Technology (IRT).

For clinical operations, transparency is pivotal throughout the recruitment process – from start to finish. For example, many biotech companies waste money on prolonged recruitment campaigns that target patients in regions that are too distant from their research sites or even overwhelm sites with unlikely referrals beyond their bandwidth. The negative consequences of this approach cost time and money and could also strain relationships with sites. In addition, it’s crucial to understand how referrals from digital recruitment campaigns actually translate into screenings, randomizations, and study completions, which involves tying together data from the study website, digital recruitment initiatives, and the EDC.

“The Axial team was making really good progress on our trial and making the best decisions we could with the data we had,” says Stewart Campbell, CEO, Axial Therapeutics. “The problem was we didn’t know what we didn’t know.”

Empowering Axial for Success - Enter Miracle - A Strategic Partner & Helpful Spotlight

Axial knew they needed something better, something that did not yet exist in the clinical trials world. They needed a strong partner to help make the best use of the data they had and fill in the knowledge and transparency gaps that could impact some of these barriers.

Campbell says when there are recruitment challenges, the typical response in the industry is to add more sites or increase ad spend for studies leveraging digital recruitment strategies, which could blindly increase cost. What eventually helped was understanding the “why” and “how” of the gaps with real-time data insights and transparency that Miracle could provide.

Since Axial was focused on a Phase II autism trial and needed study participants from specific age demographics across different countries, this presented unique patient recruitment challenges.

Additionally, the Axial team says the time and effort required for manual data compilation of spreadsheet trackers from across their trial systems, including the EDC, IRT, and study website to maintain visibility presented a plethora of challenges in their daily operations, including:

• Identifying which sources of digital advertisements were driving traffic to their study website in an efficient manner,
• Breaking down how sites were (or were not) following up on referrals,
• Proactively catching bottlenecks as patients are consented, screened, and randomized at each site, and how patients are following up on the required visits until study completion,
• Tracking drug supply at each site using their Interactive Response Technology (IRT) system based on scheduled screening visits and projected future visits,
• Mapping out when visits need to occur based on a participant’s randomization date,
• Checking if visits are occurring and whether it is within the permitted window of each visit.

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How Miracle Helped

Miracle acts as the connective tissue of clinical operations, functioning as a control room to monitor clinical trial operations using a single portal. Miracle provides a comprehensive platform that streamlines the recruitment process for clinical trials, optimizing efficiency and maximizing return on investment through transparent insights and data-driven decision-making.

In less than 2 weeks, Miracle integrated with Axial’s study website, Electronic Data Capture (EDC), and Interactive Responsive Technology (IRT), and provided an automated view of their manual spreadsheet trackers. With all the data integrated, Miracle acted as a command center for Axial’s Clinical Operations and their leadership team to stay updated in real time.

By adding more transparency into their clinical trial management processes with a single, automated dashboard, Miracle helped Axial:

• Save time that their Clinical Operations team previously spent compiling manual spreadsheet trackers on a weekly basis and at the request of the leadership team.
• Provide an automated, panoramic view of their digital recruitment funnel (social media ads to study website) and the progress from screenings to study completions – all in a platform-agnostic manner.
• Understand granular details of their study with a visual, drill-through interface to break down any metrics (i.e. number of randomizations) by sites, subjects, demographics, time periods, etc.
• Pinpoint which sites underperforming in recruitment and randomization.
• Surface real-time insights and customizable dashboards for different team members to create customized views for their specific sites or necessary metrics.
• Proactively identify issues in real-time and avoid delay in enacting solutions to bottlenecks.
• Use actual performance data of each individual site to forecast future randomizations and study timeline.
• Create ready-to-share visuals of progress for quarterly board meetings.
• Forecast randomizations based on each site’s actual performance during the trial, which was helpful for determining when to shut off digital recruitment efforts and halt additional screenings for the study.

“Miracle shined a bright spotlight into our black box with real-time, customizable dashboards that met our specific needs," says Campbell. “We needed the data compiled and presented in the right way so we could understand the impact of our efforts. This enabled us to deploy our money and resources with confidence to the places that were generating results.”

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Results

‍With Miracle, the Axial team added transparency to understand where their resources were effective and where they were not working. By visualizing progress in real time, they were able to concentrate on resolving issues as they came up, as opposed to manually compiling spreadsheet trackers for visibility, and proactively examining trends at each site to make spending more efficient and complete recruitment in a timely manner.

As a result, they were able to complete recruitment in Q3 2023, much earlier than the originally planned timeline. This represented a positive impact on company runway, which is tremendously valuable for biotech companies to not only save money but also getting that time to react to the data and chart a path forward depending on the outcome of data readout.

To learn more about Axial Therapeutics, please visit https://www.axialtx.com.

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To learn how Miracle can add transparency and save time in your clinical trial, please reach out. With our connectors with popular study platforms like Medidata Rave EDC/RTSM, Smartsheet, etc., we automate away your manual spreadsheet trackers in just a few days.
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