Clinical trials are the cornerstone of medical advancement, offering hope for improved treatments and cures. However, their success is not solely defined by the groundbreaking therapies they investigate. Instead, it relies on the effectiveness of clinical operations and the collaborative engagement of clinical research sites. Achieving clinical trial success means recognizing the interplay between stakeholders including sponsors, contract research organizations (CROs), sites, and patients. In this blog, we will explore some approaches that can help achieve optimal clinical operations.
Key Stakeholders: Sponsors-CROs-Sites-Patients Collaboration
Clinical research is far from a linear process. It is, in fact, a dynamic, symbiotic cycle where each key stakeholder has a crucial role to play. Sponsors provide the spark of innovation, necessary funding, and vital oversight. CROs contribute their expertise, efficiency, and coordination skills. Sites offer the real-world context for trials and are central to patient recruitment. Patients, the very reason for these endeavors, lies at the core of it all. To label one entity as more significant than the others overlooks the intricate interconnectedness that propels clinical trials toward success.
Historically, the clinical research landscape depicted these elements as a hierarchical structure, where requirements and directives flowed downward. However, the practical reality is far more cyclical, emphasizing the interdependence of these stakeholders. The emergence of site management organizations (SMOs) and site networks facilitates the flow of information, resources, and streamlines collaboration, further highlighting this cyclical pattern. True success in clinical trials is more efficiently attained when all parties involved support and elevate one another, leading to a transformation of the industry’s power dynamics, now reflecting this dynamic collaboration.
Start with Clear Objectives and Purpose
Defining a clear purpose and set of objectives agreed upon by all stakeholders in a clinical trial is pivotal. Everyone should understand why the specific objectives were chosen and who benefits from this in research. By cultivating sustainable practices aligned with these objectives, the industry minimizes wastage and enhances overall efficiency.
Identifying Barriers and Bottlenecks
The journey from conceptualization to clinical application is replete with challenges. Identifying and addressing barriers and bottlenecks from the outset and throughout trial execution is crucial. Process gaps or deficiencies in procedures or workflows may stem from insufficient training, staffing shortages, knowledge deficits, or communication breakdowns and can severely impede progress. Detecting the root causes of these barriers and their repercussions is of utmost importance. Overcoming these obstacles demands a comprehensive approach that considers both immediate and long-term impacts.
A Strategy to Help Improve Trial Operations Efficiency and Collaboration
Lean Six Sigma (LSS) is a method for continuous improvement in various processes. “Lean” indicates LSS’s focuses on reducing waste and cutting non-essential steps and time, therefore creating value for customers (1). Meanwhile, “Six Sigma” targets reducing variations to improve quality (1). In my experience, implementing LSS can lower costs and boost customer retention and acquisition.
The Lean Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) principle is a structured methodology used for process improvement, emphasizing data-driven decision-making and the reduction of defects or inefficiencies (2). It involves defining project objectives, measuring the current state, analyzing data to identify root causes, making improvements, and implementing controls to ensure sustained excellence in processes across various industries.
Although this approach may be implemented with any key stakeholder, let us illustrate how to execute the approach through a case study of a clinical research site preparing for patient recruitment in upcoming clinical trials. The historical issues faced were slow patient recruitment, lack of meeting enrollment targets, and high screen-failure rates.
Example: Define the project objective as identifying and addressing deficiencies in participant recruitment methods, screen-failure rates, and meeting enrollment goals.
Example: Gather data on the effectiveness of current pre-screening questionnaires, patient outreach efforts, and staff training in identifying eligible potential participants. This reveals that many individuals who do not meet the trial criteria are being pre-screened, and patient outreach strategies are not effectively targeting the right audience.
Example: Data analysis indicates that pre-screening methods, specifically the pre-screening questionnaires, lack questions that best reflect study criteria to identify the most eligible potential participants for screening. Additionally, patient outreach strategies are too broad and do not reach the ideal audience, and inadequate staff training of the protocol contributes significantly to high screen-failure rates and not meeting enrollment goals. These issues collectively lead to inefficiencies in the patient recruitment process.
Example: To address these issues comprehensively, revamp the pre-screening questionnaires to better filter out individuals who do not meet trial criteria, develop targeted patient outreach strategies to reach the right audience, and provide additional training to staff to enhance their protocol knowledge and recruitment skills.
Example: Establish ongoing monitoring and review processes for updated pre-screening methods, patient outreach strategies, and staff training, ensuring that they continue to effectively identify eligible participants, target the right audience, and maintain the efficiency of the patient recruitment process.
Embracing the Future: Collaboration and Efficiency
In conclusion, the success of clinical operations rests upon a balanced, harmonious collaboration between key stakeholders: sponsors, CROs, sites, and patients. Recognizing the cyclic, symbiotic nature of this collaboration and empowering all stakeholders allows the industry to reshape power dynamics and focus on shared objectives. This collaborative approach not only minimizes wastage but also expedites medical advancements, ensuring life-changing therapies reach those who need them most. This blog demonstrated the use of one of the Lean Six Sigma principles, guided by the DMAIC methodology, as one type of structured framework to optimize processes and enhance overall efficiency, propelling clinical trials toward resounding success. As the industry evolves, the journey from research to application will be paved with efficient processes and a shared commitment to collaboration, ushering in a brighter future for clinical trials research and patient care.
About the Author: Amber Thomas-Gordon, MBA, MS, is a Clinical Scientist and Senior Clinical Research Professional that has served the healthcare and life sciences industries for over 15 years. She has led complex multi-site clinical trials in diverse therapeutic areas, optimizing clinical development and operational efficiency, while ensuring compliance with regulatory standards. Amber’s innovative approach has consistently resulted in significant improvements in clinical capacities, advancing patient therapies and healthcare innovation through effective operations management.