Get ready to celebrate quality excellence in support of World Quality Week 2024, held each year in November! Quality assurance is generally defined as a process that helps the involved parties ensure its products meet local and industry quality standards. Throughout these last few decades alone, this process has evolved significantly from its rudimentary standards of the early days to sophisticated, patient-centered practices used today. In the realm of clinical trials and healthcare, stakeholders such as sponsors, contract research organizations (CROs), researchers, and physicians must innovate and adapt to maintain the utmost quality in the drug development process.  

From November 11 to 15, 2024, TFS HealthScience CRO is joining the efforts of the Chartered Quality Institute (CQI) and its International Register of Certified Auditors (IRCA) in this year’s global campaign to raise awareness of the quality management profession. In celebration of this year’s upcoming World Quality Week, this blog will explore how quality assurance has transformed in recent years to prioritize patient safety, regulatory compliance, and continuous improvement, reshaping healthcare and clinical trials. Continue reading to discover the key milestones that define the impact of quality assurance on healthcare excellence and patient outcomes in clinical trials! 

 

The Early Days: Basic Standards and Reactive Measures for Patient Safety 

The early days of healthcare quality assurance primarily focused on basic standards that met the minimum required regulatory compliance using fragmented reactive measures, rather than proactively striving for excellence in patient safety. These measures involved healthcare providers and institutions relying heavily on insights provided by retrospective reviews and incident reports to determine which areas needed improvement.  

The first known instance of quality improvement documentation took place in 1854, when Florence Nightingale was sent to care for soldiers fighting the war between Great Britain and Crimea. Within six months of Nightingale’s team of nurses implementing and documenting various quality improvements, the mortality rate dropped from 42.7% to 2.2%. Florence Nightingale is thought to have been guided by evidence linking handwashing and cleanliness to disease reduction in Vienna’s maternity wards during the 1840s. Later in 1861, when the American Civil War officially began, the Sanitary Commission was founded with the purpose of promoting clean and healthy conditions in the Union Army camps and hospitals. 

Although these reactive quality assurance measures were successful in improving patient safety and care, they were likely also plagued by a lack of timeliness when addressing identified quality issues. During this time, there were no standardized policies or quality metrics in place for any implemented measures, resulting in inconsistencies in patient care quality. As a result, healthcare providers could not detect and develop solutions to systemic issues as quickly. Lastly, quality assurance during this period rarely considered the voice of patients and their families, with decisions only being made by the experiences of clinicians and administrators.  

 

The GCP Era: A Turning Point in Quality Assurance for Clinical Trials 

The adoption of Good Clinical Practice (GCP) guidelines marked a significant turning point in the evolution of healthcare quality assurance. These internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects set a new benchmark for quality in clinical research. The GCP guidelines are based on lessons learned from several significant historical events, dating back to 460 BC with the creation of the Hippocratic Oath, a foundational document in medical ethics.  Key events include the following:  

1906: Formulation of United States Food and Drug Act

The United States (U.S.) Food and Drug Act became the first federal law aimed at ensuring the safety and purity of food and drugs sold across the U.S. This later led to establishing the U.S. Food and Drug Administration (FDA), a national regulatory authority overseeing the safety and efficacy of drugs. 

1947: The Nuremberg Code

The Nuremberg Code was developed in response to the unethical experiments conducted on prisoners of war during World War II. It laid the foundation for ethical principles in all research involving humans, emphasizing voluntary consent and the need for scientific justification.  

1948: Declaration of Human Rights

This declaration was developed following the devastating atrocities of World War II to establish a common standard for the fundamental rights and dignity of all individuals, namely the importance of ethical considerations and the protection of human subjects.  

1964: Declaration of Helsinki

The World Medical Association’s Declaration of Helsinki introduced guidelines for medical researchers, emphasizing the importance of ethical considerations, informed consent, and scientific rigor in clinical trials. 

Visit this page for more information on the historical events that led to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), establishing its GCP guidelines across regions such as the U.S., European Union, and Japan. 

The implementation of GCP guidelines ensured that the rights, safety, and well-being of trial subjects were protected, consistent with the principles of the Declaration of Helsinki, while ensuring that clinical trial data were credible and accurate [5]. The most-recent and widely used update was in 2016, where ICH released “E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1),” introducing updated requirements for risk-based monitoring, electronic records, and informed consent, aligning GCP standards with contemporary research needs. This shift towards standardized practices in clinical trials had a ripple effect on broader healthcare quality assurance practices, emphasizing the importance of systematic documentation, strict protocol adherence, and rigorous ethical considerations in healthcare delivery.  

 

Ensuring Patient Safety Proactively: The TQM and CQI Methodologies 

As quality assurance continued to evolve throughout the 20th century, there was a growing recognition of the need for more proactive and comprehensive approaches, which then led to the development of Total Quality Management (TQM) and Continuous Quality Improvement (CQI) methodologies in the healthcare industry. The TQM and CQI are broadly defined as follows:  

• TQM is “the management philosophy and system that promotes positive organizational change, as well as an effective cultural environment, for continuous improvement of all aspects of the organization.”
• CQI is “a systematic approach to the measurement, evaluation and improvement of the quality of all products and services, through the use of disciplined inquiry and teamwork.”

TQM and CQI emphasized the importance of involving all stakeholders in the quality improvement process, from frontline staff to senior management. They introduced concepts such as process mapping, root cause analysis, and PDCA (Plan-Do-Check-Act) cycles, which became fundamental tools in healthcare quality assurance. This era also set the stage for increasing awareness about patient-centered care as a core principle of quality assurance, with clinicians and healthcare institutions beginning to recognize that patient or staff satisfaction and engagement were crucial indicators of quality. This resulted in more widespread incorporation of patient feedback and experiences into quality improvement initiatives in the last few decades. 

 

CROs Drive the Tech Revolution: Data-Driven Quality Assurance  

As we reach modern day quality assurance in this article’s historical timeline of how quality management has evolved over the years, the impact of advancements in data management technology and data analytics tools cannot be understated. Electronic health (eHealth) and mobile health (mHealth) facilities, along with electronic health records (EHRs) and artificial learning (AI) models, have enabled more powerful big data analytics. The emergence of big data analytic tools has opened the door to analyzing databases on a much larger scale. The rise of big data has since promoted research into its applications in healthcare, imaging, smart technology, tracking and transportation systems, and more.  

As quality assurance becomes digitized using increasingly sophisticated technologies, healthcare providers have been able to adopt a more comprehensive oversight process known as risk-based monitoring. Risk-based monitoring allows for the identification of potential issues before they escalate, enabling more targeted and efficient monitoring of quality in patient care and healthcare delivery. A 2023 study found that 88% of clinical trials had adopted at least one of these components of risk-based monitoring as of 2021, an increase from 77% in 2020. Unlike the reactive measures seen in the early days of quality assurance, modern day strategies are taking a more preventative, proactive approach to maximize excellence and improvement. These technological innovations, along with the rise of telemedicine, are providing clinicians with a wealth of information to support evidence-based decision-making and data-driven quality assurance in healthcare.  

Interested in learning about how TFS CRO is approaching drug safety monitoring in clinical trials? Read our insights in this article! 

 

A Holistic Perspective: A Systems-Based Approach with Patient-Centered Practices 

Most recently, the focus of quality assurance in healthcare has shifted towards a more holistic, systems-based approach. This perspective recognizes that healthcare quality is influenced by several factors, including organizational culture, leadership, communication, and systemic processes. Adopting a systems approach has led to the development of comprehensive quality management systems (QMS) that integrate various individual quality assurance tools and methodologies. Healthcare and clinical research institutions are also placing more emphasis on creating a company culture of safety, constructive feedback, and continuous improvement, especially since the COVID-19 pandemic. It’s also important to note that more and modern quality assurance measures in healthcare are incorporating metrics to assess and improve cultural competence, language access, and health literacy to ensure that quality healthcare is accessible to diverse patient populations. 

 

Looking Ahead: The Future of Quality Assurance in Healthcare 

In conclusion, the landscape of quality assurance in healthcare will continue in its upward trajectory towards even greater innovations, as the technological capabilities of data analytics become more advanced. Above all the potential opportunities for the future, the integration of AI/ML techniques is the most exciting. These algorithms can be expected to strengthen the predictive capabilities in quality assurance, allowing for even more proactive and personalized approaches to patient care. Other possible trends in quality assurance strategies may include the emergence of more harmonized international quality standards and practices, as well as a greater emphasis on sustainability, both in terms of environmental impact and long-term health outcomes.  

As we approach World Quality Week 2024 this November 11-15, join TFS CRO and the CQI/IRCA in celebrating the indispensable efforts of quality management professionals across the healthcare industry and beyond! 

 

About TFS HealthScience Drug Safety & Pharmacovigilance CRO 

TFS HealthScience CRO is a leader in Drug Safety & Pharmacovigilance, consistently supporting pharmaceutical sponsors with experts adept at setting up, managing, and optimizing product safety needs throughout the entire clinical development pipeline. Our commitment to flexibility and tailored services set us apart in the industry and our teams understand that safety monitoring is fundamental to protecting trial participants and ensuring strict regulatory compliance. By complying with the latest quality assurance standards in healthcare, TFS can ensure that our customers’ clinical trials are conducted with the highest safety and efficiency standards, adapting in real-time to changes and maintaining robust data integrity and participant protection throughout the trial’s lifecycle.  

Visit our website to learn more about the comprehensive quality assurance and drug safety solutions TFS CRO can offer for your next clinical trial, or connect with a TFS representative today! 

Click here to learn how effective safety monitoring with the right CRO partner can lead to cost savings in clinical trials.