Training Ahead of the Danger Zone: How Commitment to Training Drives Success in Clinical Research

This article is an update of one I wrote back in 2011.? My how things have changed, yet stayed the same.? While the article focuses primarily on clinical research sites, the principles apply across all organizations.? Enjoy this updated version.

Achieving consistent high performance is about more than hitting short-term goals—it's about cultivating a culture of excellence that is rooted in training, values, and team alignment. ?Here I address how a strong commitment to training shapes a high-performing clinical research site, predicting sustained success and resilience in today’s complex clinical landscape.

Why Training Commitment Predicts Performance

When evaluating a clinical research site's potential, prior success offers some indication but isn’t always predictive of future performance. True high-performance sites embody a commitment to ongoing training and structured processes, building team resilience and readiness. This culture of continuous improvement allows sites to consistently deliver, regardless of personnel changes or new study requirements. As Dr. Connie R. Curran, a healthcare consultant, emphasized, sustainable performance relies on 'a broad range of well-trained professionals who consistently follow effective, efficient processes' rather than on 'the myth of the single, isolated, superhero.'1

Building a Culture of Excellence

Organizations that achieve lasting success embed integrity and shared purpose in their daily operations. At PCRS Network, we are driven by and coalesce around our mission of “Saving and Improving Lives by Accelerating Clinical Research.”? For a clinical research site, this starts with leadership and extends to a team-based approach, where everyone from coordinators to investigators shares a unified vision. Drawing inspiration from other industries, like Southwest Airlines’ approach of training for excellence, successful sites hire for attitude and train for specialized skills—leading to sustainable, dependable performance.

Creating Processes That Support Success

Well-defined processes are the foundation of consistency. In The E-Myth Revisited, Michael Gerber highlights that 'systems run the business and people run the systems.'2 This resonates strongly with clinical research, where Standard Operating Procedures (SOPs) go beyond task lists; they are systems that embody a culture of quality and reliability. Sites that embrace well-crafted SOPs ensure that their processes reflect excellence in every interaction, from patient engagement to data handling. This approach aligns with the philosophy of 'starting with the finish line in sight,'3 envisioning successful outcomes and structuring training and processes accordingly. Although creating comprehensive SOPs and training programs may initially be costly, the return on investment is visible through enhanced patient retention, robust data quality, and overall trial success.

Key Takeaways for Sponsors

Sponsors aiming for reliable, high-quality research outcomes should seek out sites that demonstrate a dedication to training and quality processes. Investing in such sites fosters industry growth and improves trial timelines, ultimately accelerating the journey to new treatments. Here are some recommendations: - Look Beyond Past Performance: Choose sites with a culture of learning and improvement. - Reward Training and Process Investment: Sites that prioritize training tend to perform more consistently. - Align Goals for Success: Synchronize sponsor metrics with site performance indicators to ensure mutual benefit.

The title is inspired by “Danger Zone,” Top Gun, directed by Tony Scott (1986; Hollywood, CA: Paramount Pictures), film.

#ClinicalTrials #ResearchTraining #SitePerformance #PatientOutcomes #ClinicalResearchExcellence #SavingAndImprovingLives

Endnotes

1 Connie R. Curran, “Commitment vs. Compliance: The Key to Sustainable Change,” Nursing Economics (July-August 2002).

2 Michael E. Gerber, The E-Myth Revisited: Why Most Small Businesses Don’t Work and What to Do About It (New York: Harper Business, 1995), 92.

3 Linda Pinson and John P. Neal, Develop an Exit Strategy: Start the Race with the Finish Line in Sight, Anatomy of a Business Plan (2006).