PurpleLab Tackles Clinical Trial Challenges with Managed Services

Clinical trials play a crucial role in assessing the safety and efficacy of new therapies and medical devices. Recently, the introduction of advanced statistical techniques and technologies has improved the accuracy of these trials. However, the increased complexity necessitates thorough pre-trial planning, pushing life sciences companies to seek comprehensive insights into market dynamics and the clinical landscape before launching their trials.

To navigate these challenges, companies must clearly define their testing objectives and understand the market size and clinical economics related to the health conditions they aim to address. Insights gleaned from this analysis not only shape trial design but also help anticipate how new therapies may influence existing market dynamics.

PurpleLab Managed Services provides a solution designed to empower clinical development teams to mitigate risks and enhance trial execution. By utilizing extensive real-world data, the service assists companies in preemptively identifying potential hurdles that could affect their assets throughout the clinical trial lifecycle.

Real-World Data and Strategic Planning

Jason Gagner, VP of Product Management at PurpleLab, emphasizes the importance of proactive planning. “Many clinical teams find success by developing a comprehensive action plan and establishing key performance indicators (KPIs) early in the project,” he stated. This approach ensures that transitions between trial phases are seamless, with supporting data continuously informing subsequent steps.

PurpleLab’s Managed Services aim to address critical questions regarding market access, including identifying potential adopters and monitoring barriers to uptake. Gagner explained that the company’s Health Economics and Outcomes Research (HEOR) team leverages advanced analytical methods, including artificial intelligence and machine learning, to pinpoint factors influencing disease risk and treatment outcomes. This data-driven approach enhances patient selection and recruitment while minimizing unforeseen adverse events, ultimately maximizing positive trial outcomes.

New product launches present both opportunities and challenges for life sciences companies. Gagner noted that organizations have invested heavily in bringing innovations to market, and PurpleLab focuses on understanding not just the potential market size but also the behavior of early adopters. Continuous monitoring of market indicators allows for timely adjustments to strategies, ensuring alignment with real-world conditions.

Mitigating Risks and Enhancing Outcomes

With PurpleLab’s Managed Services, companies can anticipate challenges specific to various geographic regions and healthcare systems, adapting their development strategies accordingly. Gagner pointed out that the company can monitor the clinical landscape even before the initiation of Phase 1 trials, identifying significant market concerns that might hinder the acceptance of new therapies.

For instance, in a recent haematologic disease trial, PurpleLab identified 15 high-performing sites that achieved an impressive 80% enrolment success rate, significantly reducing start-up time. Another analysis revealed trends in the utilization of PET scans across diagnoses, indicating that while overall PET scan usage increased year-over-year, the percentage of patients receiving these scans within specific groups decreased.

“This information helped us identify healthcare organizations that were likely to refer patients out of their systems for PET scans, leading to significant revenue losses,” Gagner explained. The findings suggested that addressing these referral patterns could prevent revenue losses that might exceed the cost of acquiring new PET scanners within a short timeframe.

Regulatory bodies like the Centers for Medicare & Medicaid Services (CMS) are critical in determining drug classification and reimbursement processes. PurpleLab actively tracks changes in federal policy and engages with requests for information from agencies like the FDA. Gagner highlighted a recent request for comment from the FDA focused on utilizing health data interoperability resources, indicating potential advancements in aligning clinical practice data with study submissions.

By integrating drug classifications with real-world data on demand, utilization, and disease trends, PurpleLab provides a holistic view that informs therapy development opportunities. “Understanding these dynamics allows us to help our clients navigate the evolving regulatory landscape effectively,” Gagner noted.

PurpleLab also prioritizes the standardization of terminologies used for patient populations in analytics, employing various coding systems to ensure consistency and clarity. This approach facilitates accurate communication and evaluation, particularly regarding reimbursement rates, which can vary significantly based on the specificity of coding used.

“PurpleLab’s HealthNexus platform addresses industry-wide challenges related to vocabulary management and value set maintenance,” Gagner elaborated. Without such solutions, companies often rely on inefficient methods like spreadsheet management, which lack the governance necessary for effective data management.

As clinical trial development continues to evolve, PurpleLab Managed Services stands ready to support clients in managing project costs, timelines, and milestones. By providing comprehensive insights and strategic guidance, PurpleLab aims to enhance decision-making processes for both pre- and post-marketing strategies.

With over 25 years of experience in healthcare, Gagner’s background spans healthcare operations, medical informatics, and clinical research. His leadership roles have been recognized with multiple awards, reflecting his commitment to innovation and excellence in the field. Gagner holds an MBA from Vanderbilt University and an MS in Biomedical Informatics from the University of Utah School of Medicine.

PurpleLab is dedicated to unifying healthcare language to drive better outcomes through its HealthNexus platform, which empowers stakeholders with actionable real-world evidence to tackle both conventional and emerging challenges efficiently and cost-effectively.