Maintaining Consistency Across Global Sites: Best Practices for Clinical Researchers

We live in a highly interconnected world where clinical research is no longer confined by borders. Global collaboration, with teams from all over the globe contributing to a single research effort, is now the norm. This new approach opens the door to discoveries and enhances the speed at which innovations are made. However, while global trials can help to ensure that research reflects the diversity of real-world populations, variations in regulations, infrastructure, interpretation, and even culture can create inconsistencies.

This blog explores why it’s crucial for clinical researchers to maintain consistency across all sites, regardless of location, by addressing varying regulatory requirements, training protocols, cultural norms, and other crucial factors. By adjusting their approach, clinical researchers can ensure that the data they gather is valid and inclusive while also being trustworthy.

Navigating the Challenges of Consistency in Global Clinical Trials

Multinational clinical trials pose significant challenges, as any misstep can negate efforts to standardize the resulting data. Therefore, it is important to consider the following before beginning such research:

Regulatory and compliance differences: Countries differ in customs but also in regulatory requirements. Just because something is acceptable in one country doesn’t mean it’ll be accepted in another. Consider, for example, the varying requirements of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 

Variable site experience and training: Vital data can come from anywhere and everywhere on the globe, but some clinical teams may not have the same exposure to crucial guidelines or experience with the same data systems.

Cultural influences: Engaging with trial participants can look different from one country to another. Because of this, symptom reporting and risk tolerance may be skewed, resulting in a lack of participation and ultimately reducing the quality of the data.

Local infrastructure and logistics: Supply chain issues and even connectivity problems are real-world constraints that may reduce the effectiveness of a team in one location compared to the others.

Hidden inconsistencies: From regional and local data privacy laws to how patients report vague symptoms like fatigue, an outside perspective is needed to ensure normalization of data. For instance, subjective symptom reporting may vary across cultures. Some individuals may underreport due to cultural stigma, while others overreport based on their prior healthcare experiences. 

In a systematic review of 15 studies with research teams in a variety of countries, many of the above challenges were cited as impactful. The researchers conducting the studies regularly mention a lack of skilled personnel, lack of motivation among trial participants, lengthy regulatory delays, and overly complex regulatory frameworks as barriers to their work. 

An effort to standardize the design, data collection, and reporting of clinical trials is being made in the form of the ICH E6 Good Clinical Practice guidelines. It provides a template to be used internationally to facilitate the acceptance of clinical trials by regulatory bodies in areas where the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) operates. However, this framework is not yet universally applicable. 

Proven Strategies for Achieving Consistency in Global Clinical Trials

The good news is that we can all learn from the lessons of the past, and we now know what to prepare for to protect clinical research teams from making costly mistakes, preserve the integrity of trial data, and ultimately facilitate important global health discoveries.

1. Standardize Protocols with Precision

To minimize ambiguity, trial protocols should prioritize standardized data collection methods, predefined assessment criteria, and region-specific compliance guidelines. This includes cultural protocol translation to ensure guidelines are conveyed with appropriate context. 

2. Invest in Centralized and Scenario-Based Training

Clinical research teams should implement centralized education programs that include scenario-based training to mimic real-world situations and educate participants on the outcomes of their decisions. Simulated case studies help teams identify and respond to region-specific challenges before the start of the trial. 

3. Appoint Regional Liaisons and “Data Diplomats”

CROs should recruit local liaisons with in-depth knowledge of local laws, customs, and clinical norms to bridge knowledge gaps. Enrolling the help of “data diplomats” to digest the data as it is being conducted helps to identify any obviously errant data before it impacts findings. 

4. Leverage Predictive Analytics and Real-Time Monitoring

Artificial intelligence tools like AI-powered CRMs can match eligible trial participants with relevant trials based on pre-screening data, while machine learning on data analysis identifies patterns that human reviewers may miss. 

5. Establish Strong, Consistent Communication Loops

Built unified communication tools into the workflow of research teams to highlight concerns and address misunderstandings early. Emphasize the importance of clear and consistent dialogue between all arms of the research effort. 

6. Use Localized Digital Engagement Tools

Teams should build out their documentation and reporting tools early so that patients across all regions experience a standardized trial process. Every patient at every site should have equal access to information before, during, and after the trial, with care taken to adapt to local cultural and linguistic norms. 

Why Consistency Matters in Health Equity

The reason all of this is so incredibly important is the scientific validity of the data, and not just for one population, but for a broad range of individuals. When done right, the outcomes are both accurate and fair:

• Reliable efficacy and safety data ensure treatments work across diverse populations.

• Diversity in recruitment protects the research findings from blind spots.

• Consistent application of protocols ensures regulatory compliance. 

• Uniform trial execution gives each participant the same experience while protecting data quality. 

Multinational clinical research programs have the potential to improve health outcomes on a global scale. With this awesome power comes the need for additional care, foresight, and consistency. CROs and research teams cannot stop at merely replicating protocols from one continent to the next and must instead build a framework that is flexible enough to fit local customs and regulations but rigid enough to stand up to scientific scrutiny. With the right tools, training, and cultural intelligence, this is now possible.

Rubix LS uses data‑driven clinical research and public health partnerships to accelerate equitable drug development and improve patient outcomes. To learn how Rubix LS can help streamline your global clinical trials with innovative solutions, visit Rubix LS.