Individuals often interpret the same information and terms in dramatically different ways. Multiple factors drive these variances, including culture, background, education, training, and personal biases. Unfortunately, this means when diverse global teams converge in Drug Safety and Pharmacovigilance environments, it can compromise the accurate capture and reporting of critical safety information if you do not have high performance pharmacovigilance teams in the process.
The top priority in clinical trials is to ensure a product’s safety and effectiveness. It’s crucial that safety reporting is timely, accurate, and compliant with applicable regulations and guidelines. Drug Safety and Pharmacovigilance team tasks typically include severe adverse event (SAE)/adverse event (AE) reporting and case management and analysis; medical monitoring; medical coding; and drug validation. These tasks demand clear communication and smooth collaboration among team members.
Yet, as business environments grow increasingly global and multicultural, the risk of breakdowns in communication increases. How can Drug Safety and Pharmacovigilance teams find solutions to these challenges?
The Challenge of Diversity
Today, clinical trials are often conducted simultaneously in different global locations with the goal of obtaining approvals in multiple jurisdictions. At the same time, the volume of data received by clinical and post-marketing safety groups is on the rise.
This expanding global presence introduces challenges in maintaining the continuous, uniform collection and analysis of data. The reason? The interpretation and understanding of data often varies widely among diverse team members. These variations can create discrepancies, causing misleading data analysis. However, diversity also has its advantages. These teams introduce new ideas, valuable thinking, and local knowledge into the organization.
Meeting the Challenge
To confront the challenges posed by diverse teams, organizations must standardize operating procedures and clearly communicate team objectives and expectations. These organizations can create and deploy templates as a tool to minimize discrepancies and institute training programs aimed at creating clear, consistent, and relevant reporting. These programs should include both classroom instruction and hands-on training.
Training programs should also utilize the Medical Dictionary for Regulatory Activities (MedDRA), which standardizes medical language used in AE reporting. MedDRA includes multilingual terminology and a hierarchical structure of terms used to analyze individual medical events, systems, organs, and etiology. This standardization heightens the flow and accuracy of reported data.
Another important tool is the WHO Drug Dictionary, an internationally recognized database of medical products. This tool ensures the consistent coding of drug terms and enables robust sets of clinical and safety data.
Taking the Lead
Responsibility for aligning diverse Drug Safety and Pharmacovigilance teams should fall on seasoned professionals with international experience. These leaders should be flexible, have the ability to recognize and understand cultural differences, and be capable of leveraging the value these differences contribute.
As the use of diverse global teams increases, organizations must work to ensure these teams achieve high levels of flexibility and functionality. With the right tools, training, and leadership, diverse teams can generate top performance and success levels across the organization.