Historically, quality assurance in clinical trials has always been a moving target, with the landscape of regulations and guidance changing on a continuous basis over the years. During this time, clinical trials have become increasingly complex, causing sponsors and contract research organizations (CROs) to face new challenges when balancing regulatory compliance needs with patient-centered practices that ensure patient safety. Recognizing this, the Chartered Quality Institute (CQI) and its International Register of Certified Auditors (IRCA) have set the theme for this year’s annual World Quality Week (November 11-15) to focus on the challenges of managing dynamic risk landscapes while navigating the growing complexity associated with clinical trial globalization.  

In this rapidly evolving industry, maintaining appropriate quality assurance can make or break the success of a study. Yet, the concept of quality in clinical trials is often misunderstood and can lead to inefficiencies, delays, and even compromised patient safety. In support of the CQI/IRCA’s global campaign to raise awareness of the quality management profession, this blog post aims to challenge these misconceptions head-on, offering a fresh perspective on what true quality means in the context of clinical research.  

Read on as we navigate ten prevalent beliefs about quality assurance in clinical trials and discover whether they are fact or fiction! 

 

1. Fact or Fiction: Compliance Equals Quality

Fiction: While compliance with protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and regulatory standards is crucial, it is a common misconception that compliance alone guarantees quality in clinical trials. In truth, compliance only establishes the baseline for conducting trials ethically and safely, whereas true quality in clinical research extends far beyond regulatory compliance. In today’s clinical trial landscape, sponsors and CROs must adopt a holistic approach to quality monitoring by implementing additional strategies involving continuous improvement, proactive risk management (e.g., risk-based monitoring), and a company culture that values scientific integrity and patient safety above all. Therefore, while compliance is necessary, making it the sole focus of quality assurance efforts runs the risk of researchers overlooking other critical aspects of trial quality that could be impacting the validity and reliability of a study.  

 

2. Fact or Fiction: Quality Assurance Can Prevent Delays in Clinical Trials

Fact: Strict quality assurance can indeed prevent delays in clinical trial project management. By conducting thorough quality checks at the outset and throughout the drug development process, research teams can catch and address any inconsistencies, errors, or compliance issues that might have otherwise led to costly setbacks that require time-consuming corrections later on. In a 2023 analysis conducted by the Tufts Center for the Study of Drug Development, the estimated direct daily cost to conduct a clinical trial is approximately $40,000 per day for phase II and phase III clinical trials. In fact, they found that even one day of delay translated to approximately $500,000 in lost prescription drug or biologic sales for pharmaceutical sponsors. To avoid these costly consequences, proactively identifying and implementing quality measures early in a study’s lifecycle can be an effective strategy for sponsors and their CRO partner to keep projects on track and ensure smoother timelines.  

 

3. Fact or Fiction: All CROs Maintain the Same Quality Standards

Fiction: The idea that all CROs adhere to identical quality assurance and quality control standards is actually a common misconception in the clinical trial industry. Of course, maintaining regulatory compliance is a fundamental requirement for all CRO partners in a study, but the reality is that each organization will vary in their quality standards, such as in their quality culture, investment in staff training and development, and commitment to continuous improvement processes. As seen in any industry, some CROs stand out more than others because they have a reliable track record of going above and beyond basic regulatory compliance and quality assurance methods.  

Industry leaders in quality typically take initiative by implementing efficient quality management systems (QMS), intentionally fostering a culture of sustainability and excellence, and consistently looking for ways to improve their approach. Differences in quality standards can significantly impact a study’s outcomes and overall success, as well as influence patient safety. Therefore, sponsors must consider a CRO’s quality practices and history in order to select the right partner for their clinical trial.  

 

4. Fact or Fiction: The Clinical Trials Industry Has Always Prioritized Patient Safety

Fiction: Contrary to popular belief, patient safety was not always the primary focus in clinical trials. Unfortunately, there were significant gaps in drug safety protocols that remained hidden until events like the thalidomide tragedy in the 1960s exposed them. Between the late 1950s and early 1960s, thalidomide was used across 46 countries to treat morning sickness in pregnant women. However, the lack of comprehensive safety testing on the reproductive toxicity effects of thalidomide resulted in more than 10,000 children being born with a range of severe physical deformities, as well as thousands of miscarriages taking place.  

This incident led to a global overhaul of clinical trial regulations, bringing patient safety and informed consent to the forefront. Specifically, the thalidomide disaster and its subsequent withdrawal from the market was a turning point in toxicity testing, as it prompted United States (U.S.) and international regulatory agencies to develop more robust toxicity testing protocols. This case offers crucial lessons about the importance of quality standards in clinical research that are still just as important today. This incident also underscores the need for strict global clinical research regulations that prioritize patient safety and thorough trial oversight. Accordingly, the World Health Organization recently launched its landmark publication “Guidance for best practices for clinical trials” in September 2024. Read more about this latest foundational resource in clinical trial quality here. 

 

5. Fact or Fiction: Risk-Based Monitoring (RBM) is an Efficient Quality Measure

Fact: RBM, or risk-based quality management (RBQM), is a powerful quality assurance measure for efficiently ensuring patient safety and data integrity in clinical trials. Whereas traditional monitoring involves exhaustive oversight over all trial sites and data, RBM allows for a more targeted approach by prioritizing only high-risk areas for error. For example, certain therapeutic areas such as oncology may be more prone to protocol deviations or certain sites may have a track record of frequent data errors. In response to these areas that require additional attention, RBM enables tailored solutions to be implemented proactively and continues to monitor risk throughout the trial in real-time. Since 2019, the use of RBM as a quality measure in clinical trials has increased from 53% to 88% as of 2021. This is likely because, unlike with a one-size-fits-all approach, sponsors and CROs can optimize their resource allocations more effectively with RBM, while still reaping significant benefits in quality improvements.  

 

6. Fact or Fiction: Quality is the Sole Responsibility of the Quality Assurance Team

Fiction: Quality is a shared responsibility that extends to every individual involved in the clinical trial process. Naturally, the quality assurance team plays a central role in the oversight and compliance with the required standards, but true excellence in quality can only be achieved with the collective efforts of all team members. Every stakeholder in a clinical trial is able to contribute to maintaining high standards in data integrity and patient safety: 

• Principal investigators (PIs) ensure overall protocol adherence and accurate data collection across their clinical research sites. 
• Clinical research coordinators (CRCs) maintain meticulous records of clinical trial data and patient care tasks.  
• Data managers are responsible for overseeing and safeguarding data integrity at all times.  
• Clinical research associates (CRAs) carry out RBM and source data verification (SDV) to ensure accuracy and consistency in a site’s data records.  
• Lab technicians follow precise technical procedures for biological sample handling and analysis. 

This collaborative approach to quality not only enhances the reliability and validity of trial results, but it also fosters a culture of excellence in quality assurance throughout the entire organization.  

 

7. Fact or Fiction: More Quality Assurance Checks Mean Better Quality

Fiction: Contrary to popular belief, increasing the number of quality assurance checks does not necessarily lead to better quality in clinical trials. This misconception stems from the idea that more oversight equates to higher standards, but quality actually entails implementing smart, targeted checks rather than overwhelming the process with excessive controls. The concept of quality over quantity in this case relates to the use of RBM in assessing and addressing potential issues in clinical trials.  

RBM has steadily grown in its support within the clinical trial industry. In June 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance, calling for greater support of RBM principles throughout clinical trial planning and execution. For more than a decade, the use of RBM has also been encouraged via Quality by Design principles and the ICH GCP E6 (R2) guidelines. The risk-based approach strategically allows sponsors and their CRO partners to divert resources toward high-impact areas, rather than spreading them thin across the board. The goal is to collect the right data, not necessarily more data.  

Sponsors and CROs can adopt several key strategies for smart quality assurance checks that do not overburden staff with excessive oversight: 

• Focus on high-priority data points that directly impact patient safety and study outcomes. 
• Leverage advanced analytics (including artificial intelligence [AI] input) to identify data patterns and potential issues. 
• Promote a supportive culture of regulatory compliance, quality, and transparency throughout every level of the company.  

 

8. Fact or Fiction: EDC Transformed Data Quality in the 1990s

Fact: Electronic Data Capture (EDC) systems indeed began to reduce data entry errors and improve monitoring capabilities in the 1990s, marking a significant leap forward from manual data entry. This advancement set the stage for today’s data accuracy standards in clinical trials. The concept of EDC systems began with the introduction of remote data entry (RDE) as early as the 1980s, helped along with the creation of computers, floppy disks, and easier connection via technology. Before this time, data collection in clinical trials were primarily paper-based and required manual entry, involving time-consuming duplicated efforts for staff; naturally, these traditional methods were associated with a greater risk of data errors and inconsistencies.  

Since their introduction, EDC systems have expanded to cloud-based platforms to provide greater scalability, flexibility, and real-time accessibility, enabling faster, more efficient clinical trials. Newer technology has also emerged, allowing for the integration of EDC with digital clinical tools such as clinical trial management systems (CTMS), electronic patient-reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), and electronic consent (eConsent). Today, EDC systems are almost universally used across the pharmaceutical industry, and they have become indispensable tools for maintaining appropriate quality in clinical trials.  

 

9. Fact or Fiction: Stringent Quality Measures are Too Expensive and Slow Down Trial Progress

Fiction: Lack of funding is admittedly a common limiting factor when it comes to quality improvement initiatives, but despite requiring initial investment, stringent quality measures often lead to cost savings in the long run. Even small changes can make a big impact on the efficiency of a clinical trial by leading to more targeted resource allocation and utilization, which can further reduce costs while improving patient safety and care. The relationship between limited investment in quality assurance measures and patient outcomes can be seen in low- and lower-middle-income countries, which still have a much higher rate of maternal and pediatric mortality compared to upper-middle-income countries.  

Understandably, there may be a systemic cost barrier in certain regions to obtaining tools and technology that can improve efficiency in clinical trials, which highlights the need for more funding in quality management initiatives worldwide. After the upfront costs, proactive quality assurance strategies can prevent costly errors, reduce the need for extensive repetition of work, and avoid regulatory compliance issues that could delay trial completion or product approval.  

 

10. Fact or Fiction: Once a Trial is Underway, It is Too Late to Implement New Quality Measures

Fiction: It is another misconception  that sponsors and CROs must choose and finalize all quality assurance measures by the time of clinical trial initiation.. While this may be the ideal, the reality is that no study will ever be perfect from the outset, making continuous improvement an inevitability that must be anticipated and embraced. There is always time and room to implement new quality strategies or refine existing ones to significantly improve trial outcomes. In support of this, the U.S. FDA encourages sponsors to adopt a quality-by-design approach, which involves ongoing assessment and improvement of quality throughout the trial lifecycle.  

This concept of pre-planning adjustments to a study is also the basis of adaptive clinical trials, which allow for the preplanned modification of an ongoing clinical trial based on the accumulating evidence, often patient data collected up to the point of interim analysis [17]. Adaptive designs better represent the dynamic nature of this industry and allow greater flexibility for sponsors and CROs to make quality adjustments on a continuous basis throughout the study.  

 

Conclusion 

In conclusion, quality in clinical trials is about more than just compliance. Instead, it is about ensuring patient safety, data integrity, and scientific rigor. In this blog, we debunked common myths and highlighted key truths about quality assurance to demonstrate that it is a dynamic, collaborative effort that extends beyond regulatory compliance requirements. By staying informed about best practices and remaining flexible in their approach, sponsors and CROs can conduct trials that are not just compliant but integrate quality patient-centered practices that safeguard patient safety. 

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!