Real-World Evidence (RWE) stands at the forefront of modern healthcare, providing valuable insights from real-world data (RWD) to help shape medical decisions and policy. Within clinical trials, RWE is increasingly used to complement traditional trial data, providing insights into the real-world effectiveness and safety of medical interventions across diverse patient populations and settings. 

TFS HealthScience is a global, mid-sized contract research organization (CRO), with a commitment to RWE that is rooted in utilizing diverse data sources to rigorously assess medical interventions’ real-world effectiveness and safety beyond traditional clinical trial settings. 

This article aims to shed light on the importance of RWE in clinical research and highlight the exceptional work of the TFS RWE team, showcasing their commitment, achievements, and future goals.  

 

Importance of RWE in Clinical Research 

RWE is a crucial part of conducting clinical research, as it enhances the robustness and applicability of findings from traditional clinical trials. Unlike controlled environments of clinical trials, RWE is from real-world settings, capturing diverse experiences of patients in routine practice. This authenticity provides valuable insights into the effectiveness and safety of medical interventions across varied populations and settings. 

Additionally, RWE contributes to the optimization of clinical trial designs, facilitates post-market surveillance, and supports regulatory decision-making. Ultimately, RWE is critical for a comprehensive understanding of how effective and safe a medical device, drug, or intervention is in diverse patient populations. 

 

TFS’s RWE Core Capabilities and Expertise 

The RWE team at TFS boasts global and local capabilities with a diverse set of expertise in scientific, epidemiological, medical, technological, and operational aspects. Their offerings include strong design and analysis expertise, strategic consultancy, and specific procedures, setting a high-quality standard for operational delivery in studies of varying complexity. 

TFS RWE Offerings:   

• Strong design and analysis expertise  
• Strategic consultancy: scientific and commercial value  
• Excellent operational delivery (from most simple to most complex)  
• Standard procedures and Guidance (incl. GPPs and EnCEPP )    
• Internal & external RWE training  
• Site network database & KOLs  
• Members of STRATOS Initiative: Strengthening Analytical Thinking for Observational Studies (international guidance and tools)  
• Members of OHDSI Initiative: Observational Health Data Sciences and Informatics (international network of researchers and observational health databases) 

 

What Sets Our RWE Team Apart? 

The TFS RWE team, led by Neus Valveny, Senior Director, Head of RWE, distinguishes itself through a unique blend of global capabilities and local expertise spanning 20+ countries, with over 25 years in non-interventional studies (NIS). Over the past five years, they have provided services for over 250 RWE studies, enrolling over 78,000 patients across 7,300 sites in 19 countries, including European, U.S., Latin, and APAC regions. 

The team’s unparalleled proficiency empowers clients to maximize the benefits of big data analyses in clinical development. Noteworthy advantages include integrating external control arms and RWE from various geographies into submission dossiers, avoiding costly and protracted trial arms/extensions. This approach enables early detection of health risks, streamlining diagnoses and treatments, contributing to healthcare optimization, and enhancing patient access. 

TFS is also committed to advancing RWE through strategic collaborations and partnerships. The team’s recent endeavors include a noteworthy partnership with PINC AI™, a collaboration that amplifies TFS’s capabilities in leveraging artificial intelligence (AI) for enhanced RWD analysis. The PINC AI™ Healthcare Database comprises real world data from +1,300 healthcare sites and over 2.7 billion individual patient encounters, representing approximately 45 percent of all U.S. admissions, including inpatient and outpatient data on procedures, drugs and diagnostic evaluations such as vitals, imaging, and laboratory and tests.   

This extensive coverage will allow TFS customers to obtain detailed feasibilities and large population-based real-world evidence (RWE) and external control arms for drugs and medical device studies. 

 

Recent Work and Achievements 

Recently, TFS’s RWE team has been making remarkable achievements. Here’s a glimpse at what they’ve been up to. 

EU Medical Devices Regulation Study 

• Completed recruitment for the first study to meet new EU Medical Devices Regulation (MDR 2017/745) requirements in May 2021. 
• Overcame challenges with a device trial, that included five similar devices in a single protocol, demanding extensive reporting for CE marking. TFS’s statistical and programming team delivered numerous reports, and the data management team improved the device-complaint form processing procedure, leading to substantial process improvement. 

 

Cardiovascular Patient Registry Turnaround 

• The team efficiently turned around recruitment for a cardiovascular patient registry to meet the December 31st, 2023, deadline. 
• Recruited over 1,200 patients across 7 countries, showcasing adaptability to evolving recruitment strategies. 
• Received commendation from the client for professionalism and a positive attitude in successfully concluding the challenging recruitment. 

“I do not want to miss the opportunity to acknowledge the excellent progress with the recruitment. We appreciate a lot the efforts made by all the team…please share this recognition to your team.” – Sponsor´s Director of Clinical Development 

 

Complex Dermatology Trial Setup 

• In a late-phase dermatology trial, the RWE team played a crucial role in clinical and background initiatives. 
• Provided process flow outlines, front-line IT support, and tips for first visits to ease challenges in technology infrastructure setup for investigators and patients. 
• Collaborated with vendors to establish a comprehensive technological infrastructure, overcoming challenges with eConsent technology, ePRO notification messaging, and operational sensors. 

 

Poster Presentation at ISPOR 2023 

In November, the RWE team presented a groundbreaking poster at the ISPOR Europe Congress in Copenhagen. The insightful presentation, titled “Improving Analysis of Continuous Predictors: Advantages of Fractional Polynomial Transformations and Interpretation of Non-linear Odds Ratios or Hazard Ratios,” focused on the critical importance of continuous predictors in medical analytics. The poster illuminated the limitations of traditional linear assumptions, advocating for the advanced use of Fractional Polynomial transformations. Plus, it looked at the development of a new visualization tool to help understand “non-linear” Odds and Hazard Ratios. 

Tune in to the virtual recording to discover a deeper understanding of non-linear odds and hazard ratios in real-world evidence studies and their profound impact on medical decision-making. 

 

What to Expect from TFS’s RWE Team in 2024 

The TFS RWE team is poised to expand beyond traditional post-approval services and extend into pre-approval services. Additionally, they plan to enhance sponsor awareness regarding the advantages of Common Data Models (CDM) for RWD. There are many benefits of OMOP-CDM, including open-source developments, new methodological research, and reproducibility, just to name a few. 

The team will also utilize OMOP- OMOP-CDM, which offers multiple advantages, such as rapid results, cost-effectiveness, investigator-friendly study designs, a federated approach ensuring compliance, and substantial sample sizes for robust analysis. 

 

Conclusion 

RWE plays a pivotal role, providing invaluable insights derived from authentic data to shape medical decisions and policies. TFS HealthScience stands at the forefront of harnessing diverse data sources to rigorously assess the real-world effectiveness and safety of medical interventions. 

The dedication of TFS’s RWE team members reflects TFS’s commitment to excellence. The team’s recent achievements showcase their resilience and commitment to overcoming challenges and thinking strategically. As they embark on future endeavors, it’s clear that TFS HealthScience is poised for continued success and growth. 

Thank you, TFS HealthScience’s RWE Team, for your unwavering commitment to healthcare advancements. 

 

Want to learn more about our RWE and CRO services? Connect with us today!