From the technological systems that handle data collection to the physical facilities that safely deliver complex therapies to patients, appropriate health system infrastructure is critical to the successful conduct and completion of clinical trials. Nevertheless, health systems are often fragmented,1-2 under-resourced3 and lacking in well-established processes, equipment or physical facilities to deliver the coordinated care required in a clinical trial. Innovation from life science manufacturers may also have the unintended consequences of increasing complexity for clinical trial sites—with 56% reporting that trial complexity has increased since 2020. Moreover, 53% say they lack the bandwidth to run trials, up from 14% pre-COVID-19 and 47% at the height of the pandemic.4 To ensure that new interventions can be practically integrated into real-world use, experts must understand the intricacies of health systems and how they are involved in designing and implementing successful clinical trials.
In the context of clinical trials, health system infrastructure refers to the foundational physical, organizational and operational structures and resources that enable effective and efficient clinical research. Through Petauri Kinect’s extensive experience with health systems, we identified 3 key components of health system infrastructure necessary for successful clinical trials: technological systems, physical facilities and trained personnel.
Technological Systems
One of the biggest hindrances to clinical trial efficiency is technology and data. Yet, health information technology (HIT) and electronic health record (EHR) systems are crucial for clinical trials due to their role in subject selection (identification of eligible subjects within existing health system data), data capture (integration of clinical trial patients’ background information with trial findings and outcomes) and data analysis (selection of software and programs suited for the therapeutic area, product and/or manufacturer). A lack of standardization in HIT/EHR infrastructure can lead to increased costs while improper processes for data sharing among clinicians, review boards, patients and regulators can lead to significant delays and potential inaccuracies in trial outcomes.5 The insufficient technological infrastructure also poses barriers to clinical trials due to the unreliability and inaccuracy of clinical data captured in routine practice for trial purposes. Many health systems with multiple facilities use EHRs, clinical trial management systems and data monitoring tools that vary from facility to facility and may not adequately communicate with each other. 60% of clinical trial sites reported using 20 or more systems daily to manage their clinical trials.6 Unfortunately, changes to technological infrastructure are slow and costly. Petauri Kinect has considerable experience identifying the most efficient and effective IT solutions and expediting their adoption by demonstrating how they can lead to cost savings and increased efficiency.
Physical Facilities
Many systems are also poorly equipped to care for patients with multiple comorbid conditions who require complex therapies or frequent laboratory analysis. Complex therapies that involve CAR T-cells, bispecific antibodies, CRISPR and other gene or cell therapy methods may require sophisticated physical infrastructure that represents a barrier to the participation of smaller health systems and/or clinical trial sites. For example, centers providing CAR-T cell or bispecific therapies may be required to obtain Foundation for the Accreditation of Cellular Therapy (FACT) certification. In other instances, centers evaluating advanced therapies may require specialized cellular therapy laboratories. Health systems that outsource laboratory analysis may also struggle with inadequate turnaround time and questionable quality of the analyses. As life science manufacturers pursue narrower indications with increasingly complex drugs and devices, clinical trial sites often struggle to execute trials effectively due to a lack of necessary physical resources and facilities. Without expert health system understanding, these issues remain unchecked and compound over time. Petauri Kinect has found that clinical trial immersions (primary and secondary research) frequently reveal that manufacturers may not fully understand the challenges involved in health systems’ and clinical trial sites’ physical infrastructure, indirectly preventing companies from successfully piloting trials. In these situations, Petauri Kinect helps life science manufacturers identify challenges and offer the necessary support to overcome these challenges.
Trained Personnel
The success of any trial requires the availability of skilled healthcare providers, trained research staff—including clinical trial coordinators, data managers and laboratory technicians—and qualified support staff. However, in some health systems, staff may struggle with a lack of clarity in their roles and responsibilities for delivering and monitoring patient care.1 Staff must be knowledgeable about how to help patients overcome barriers to clinical trial participation including a lack of awareness or trust in the value of clinical trials, the cost and logistics of travel, concerns about potential risks of participation, and the possibility of cultural or language barriers. Petauri Kinect can help health systems identify and address these barriers to ensure that pharmaceutical and biotech companies provide the clinical navigation and supportive services necessary for efficient clinical trials.
Pharmaceutical and biotech companies require seamless integration with health system technology, physical facilities and personnel to ensure that new interventions can be evaluated and adopted seamlessly. Clinical trials may fail without a deep understanding of the necessity of each of these components. These infrastructure factors can be crucial to completing clinical trials efficiently and translating key clinical findings into real-world settings. Pharmaceutical and biotech companies should gain greater knowledge of the complex dynamics within health systems. In turn, they can reduce the risk of clinical trial delays and costs, enhance commercialization efforts and increase the likelihood of successful launches. In the future, Petauri Kinect will continue to explore other factors influencing clinical trial excellence. We encourage you to stay tuned for valuable insights!
At Petauri Kinect, we empower life science organizations to navigate the complexities of today’s evolving healthcare landscape. With over 20 years of experience combining deep industry insights 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. Contact us at inquiries@petauri.com or here.
References
- O’Davis, M. M., Devoe, M., Kansagara, D., Nicolaidis, C., & Englander, H. (2012). “Did I Do as Best as the System Would Let Me?” Healthcare Professional Views on Hospital to Home Care Transitions. Journal of General Internal Medicine : JGIM, 27(12), 1649–1656. https://doi.org/10.1007/s11606-012-2169-3
- Baillie, L., Gallini, A., Corser, R., Elworthy, G., Scotcher, A., & Barrand, A. (2014). Care transitions for frail, older people from acute hospital wards within an integrated healthcare system in England: a qualitative case study. International Journal of Integrated Care, 14(1), e009–e009. https://doi.org/10.5334/ijic.1175
- Waring, J., Bishop, S., & Marshall, F. (2016). A qualitative study of professional and carer perceptions of the threats to safe hospital discharge for stroke and hip fracture patients in the English National Health Service. BMC Health Services Research, 16(1), 297–297. https://doi.org/10.1186/s12913-016-1568-2
- Flanagan, J., & Evers, J. (n.d.). How Customer-First Clinical Trials Cut Complexity and Delays. Bain & Company. Retrieved from https://www.bain.com/insights/how-customer-first-clinical-trials-cut-complexity-and-delays/
- Uebele, S. (2024). Improving America’s Clinical Trial Infrastructure. Retrieved from https://www.linkedin.com/pulse/improving-americas-clinical-trial-infrastructure-scott-uebele-rmclc/
- MSCR (2023). Closing the Gap on Clinical Tech for Sites. Retrieved from https://myscrs.org/resources/sites-now/closing-the-gap-on-clinical-tech-for-sites/