Transparency in Clinical Operations: How Inhibikase Therapeutics Built a Control Room for a Faster, More Accurate Trial with Miracle

As a biotech company focused on Parkinson's research, Inhibikase Therapeutics knows the importance of efficient clinical operations to achieve a timely data readout.

Like in most clinical trials, time is of critical importance. For the clinical operations team at Inhibikase, it was critical to proactively catch potential issues in their clinical trial recruitment pipeline, collaborate with their social media provider to drive traffic to their study website where potential patients could fill out a prescreener, and coordinate with sites to work on referrals quickly. As enrollment progressed, it was also important to track drug supply inventory and status, and conduct ongoing data review to ensure timely resolution of open queries.

Their situation is not unique. Many clinical operations teams at smaller biotech companies often find themselves working closely with their Contract Research Organization (CRO) to juggle multiple vendors and research sites so that they can minimize delays and inefficiencies and conserve runway.

After struggling with siloed information and time-consuming spreadsheets, Inhibikase turned to Miracle for a simple yet game-changing solution. In this blog post, we'll explore how Inhibikase leveraged Miracle to add transparency into their clinical trial management processes for their phase 2 trial (NCT05424276).

‍

The Challenge - Too Little Time, Too Few Resources

At Inhibikase, the company’s goal is to develop groundbreaking therapies for Parkinson's disease. With a phase 2 trial underway, the clinical operations team needed a reliable and comprehensive solution that could help them stay on top of what’s working and not working in their clinical trial management and processes.

The study team also needed to find a way to aggregate and surface that data in insightful ways. Reports from their Medidata Rave Electronic Data Capture (EDC) system and Randomization and Trial Supply Management (RTSM) weren’t easily customizable to answer new questions that arose as it related to enrollment, data review, and drug supply. In addition, the pace at which data was being reported from their CRO and vendors, which tend to be weekly across the industry, limited their ability to proactively identify trends and potential bottlenecks in their recruitment efforts.

After trying to keep track of information in spreadsheets like Excel and Smartsheet, the team felt like they all fell short of meeting their needs. Spreadsheets were time-consuming and prone to errors, while other solutions lacked integration capabilities, making it difficult to combine data from different systems.

“If our clinical trial sites are efficiently recruiting, screening, and randomizing participants, as well as promptly cleaning data, then I don't need to prioritize my time on those tasks,” said Chris Meyer, VP of Clinical Operations, Inhibikase Therapeutics.

“Conversely, if any sites are falling short in recruitment, randomization, or other required tasks, I will allocate my time and my team's time to address those issues promptly, this is what Miracle allows us time to do,” he said.

“For clinical operations, time is our biggest threat,” he said.

But what if there was a way to seamlessly connect the disparate platforms and vendor reports, and gain valuable insights in one place? That's where Miracle came in.

Meyer recognized that a bigger industry challenge is siloed data across systems. The challenge lies in consolidating this data into a centralized platform that seamlessly integrates and doesn't demand extensive IT resources, particularly for small biotech companies.

‍

‍Enter Miracle - Data Integration and Visualization to Put Clinical Operations in Control

Miracle provided an opportunity to serve as a virtual “command center” or control room that presented a unified reporting platform delivering impactful and automated insights in real-time. This helped the team understand all the dynamics at play and determine gaps and priorities – enabled by the insights from Miracle.

For their clinical operations team, the value that made Miracle stand out was for its seamless integration capabilities and user-friendly interface, making it effortless to pull data from across their trial data sources, including their study website, Medidata Rave EDC and RTSM, and gain a comprehensive overview of the study’s progress from a centralized dashboard.

With Miracle, the team streamlined their clinical trial management and reporting significantly. They no longer needed to spend hours manually inputting data into spreadsheets or navigating between different systems to gather information. Instead, the platform automatically aggregated all necessary data points into customizable and interactive dashboards, making it easy to answer new questions and drill into visualizations to obtain granular site-level and subject-level details.

Miracle’s robust analytics features provided the team with valuable insights into the trial’s progress and performance metrics in real-time. This empowered them to proactively identify any issues or bottlenecks in their recruitment pipeline and address them promptly before they could impact the trial’s timeline, as opposed to previously reacting to issues identified in the weekly vendor reports.

“So time is of the essence and Miracle meets the call at every point.” Chris Meyer, VP, Clinical Operations, who has been using Miracle nearly 7 times a day on average over the course of their Phase 2 trial.

Another significant advantage of using Miracle is its focus on maintaining data integrity and many data integration capabilities. Proactively monitoring open queries and time to resolution at the site-level and subject-level allowed the team to have more data-driven conservations with their research sites to ensure the quality of the study data.“We've seamlessly integrated various components, beginning with advertisements and how individuals are directed to the Inhibikase study website -- the201trial.com. “Additionally, we're enabling the analysis of those referrals into screenings and randomizations at sites, but also the corresponding drug supply and data quality at each site as visits occur,” said Jin Kim, Founder and CEO, Miracle.

‍

Scaled for Success - Results and Benefits of Miracle

Since implementing Miracle, the team has seen a significant improvement in clinical operations management as well as more opportunities for building out new dashboards to address various phases of recruitment. The team can now focus on analyzing and interpreting the data instead of spending hours aggregating it and compiling spreadsheet trackers, or waiting for their next weekly vendor reports. This has not only improved efficiency, but has also allowed for the ability to make data-driven decisions faster.

Improved Patient Recruitment

The establishment of a single portal for monitoring the end-to-end recruitment pipeline has emerged as a pivotal element in their strategy, potentially serving as one of the main factors in regaining the time lost and helps with future trial planning. This approach has not only streamlined the process of analyzing which channels are the most effective at attracting potential participants to the study website and translating to referrals based on the prescreener responses but also has facilitated a more efficient collaboration between their team and trial sites on how they are following up with potential participants from referrals.

Future Trial Planning - Phase 3

By having a comprehensive report card on every trial site, including details such as referral sources, time to act on referrals, data entry speeds, response times to query resolution, and screening and randomization rates, the Inhibikase team can gain valuable insights that inform the execution of subsequent phases. This data-driven approach ensures that future trials are conducted efficiently and effectively.

‍

Innovating for Future Clinical Trials

As Chris and team look to the future of Inhibikase trials, he’ll be looking to Miracle as his go-to-solution for planning his next trial.

“Miracle will become a critical part of the design and build process for our future trials,” said Meyer. “And when you start to extrapolate that into where something like Miracle can take us going forward, I think it's a huge value add to be able to see where waste is in the system.”

Meyer said the key cost savings was clawing back the lost time associated with slow recruitment. The value of lost time correlates to the company’s monthly burn rate, which is the biggest threat to their organization’s long term success, and ultimately, patient success.Meyer believes the power of Miracle’s insights are more impactful than buzz around AI in the industry right now. Without a comprehensive grasp of the data being inputted, AI systems become less effective tools, resulting in inefficiency.Miracle's data integration advancements represent a data-driven approach to solving the enduring challenges of clinical operations. By providing integrations that unify the entire spectrum of clinical trial management, Miracle is setting a new standard for transparency and efficiency in clinical operations.

For more information on Inhibikase Therapeutic’s phase 2 trial for patients with untreated Parkinson’s Disease, please visit https://www.the201trial.com.

‍

To learn how Miracle can add transparency in your clinical trial, please reach out. We help you get up and running in less than a week, saving you time from the very start.