Understanding the Health System Dynamics Impacting Clinical Trials 

Clinical trials are a foundational element of the US healthcare system. According to the National Library of Medicine, the number of registered clinical trial studies worldwide surged at a compound annual growth rate of approximately 27% from 2000 to 2023.¹ The dramatic increase underscores a trial’s role in advancing health and science–from discovering new treatments to innovating disease detection, diagnosis, and prevention methods. However, as the volume and complexity of clinical trials expand, so do the challenges associated with operationalization and management.  

Understanding the constantly evolving healthcare landscape helps improve the efficacy of clinical trials. 

The Challenges of Clinical Trials 

Approaching Phase II and III of clinical trials is especially crucial as these stages evaluate a drug candidate’s safety and effectiveness in a larger patient population or against current treatment standards.² Yet, many clinical programs fail during these pivotal stages due to clinical and non-clinical challenges. The latter demonstrates a lack of commercial interest or poor strategic planning. As the healthcare landscape continues to transform, the success of clinical trials increasingly depends on a deep understanding of health system dynamics. 

The Value of Health Systems 

For pharmaceutical and biotechnology companies, aligning trial strategies with health system knowledge not only improves clinical trial efficiency and effectiveness but also lays the groundwork for successful commercialization. In particular, health system engagements create a partnership between biopharmaceutical clients and clinical trial sites, enabling these sites to transform into centers of excellence (COEs). COEs can become indispensable to accelerating commercial adoption.  

The Factors of Trial Success 

Health systems are part of a vast and complex ecosystem, marked by consolidation and multiple payments. Most recently, the legacy hospital-centric care model has given way to integrated, value-based care systems. Alongside shifts in market trends and technological advancement, these changes have created a new set of dynamics and workflows that significantly impact clinical trials. Petauri Kinect has identified four factors that influence trial success:  

• enrollment and referral patterns 
• stakeholder engagement 
• education 
• infrastructure 

These factors affect recruitment success, foster trust and collaboration, and ensure diverse and equitable representation. In the future, Petauri Kinect will publish in-depth blog posts on these topics. We encourage you to stay tuned for valuable insights! 

The clinical trial and development space is rapidly changing, and biopharmaceutical companies want to ensure the success of their candidates amidst countless complexities. At Petauri Kinect, we empower life organizations to navigate the complexities of today’s evolving healthcare landscape. With over 20 years of experience combining deep industry insight with diverse advisory expertise, we drive innovative strategies that lead to success.  

Petauri Kinect enables biopharmaceutical clients to forge strong partnerships with key customers and help position clients for short-term and long-term success. 

References 

1. Trends and Charts on Registered Studies. Clinicaltrials.gov. September 4, 2024. Accessed September 4, 2024. https://clinicaltrials.gov/about-site/trends-charts. 
2. Torres-Saavedra PA, Winter KA. An Overview of Phase 2 Clinical Trial Designs. International Journal of Radiation Oncology, Biology, Physics. August 4, 2021. Accessed September 19, 2024. https://pubmed.ncbi.nlm.nih.gov/34363901/.