The Future of Oncology Research in Europe: Integrating Real-World Evidence into Joint Clinical Assessments

The global healthcare landscape is rapidly evolving, driven by advancements in technology, changes in regulatory frameworks, and an increased focus on patient-centered care. One of the pivotal developments in recent years is the concept of Joint Clinical Assessment (JCA), particularly within the European Union (EU).  

JCAs represent a collaborative approach to evaluating the clinical value of new health technologies across multiple EU member states. This initiative is part of the EU Regulation on Health Technology Assessment (HTA), which strives to ensure more equitable access to innovative treatments across Europe.  

A critical aspect of JCAs is the integration of real-world data (RWD) and real-world evidence (RWE), which are increasingly recognized as essential components of the clinical assessment process alongside clinical trial data. 

We spoke with Markus Rückert, PhD, Medical Director at TriNetX Oncology, about JCAs relative to oncology research, the roles of RWD and RWE in the new process, and how TriNetX is unlocking the potential of RWD and RWE for the evaluation of oncology therapies at the EU level.

When are JCAs taking effect for oncology therapies? What are the goals? 

Beginning January 2025, there will be a gradual implementation of JCAs for oncology products with mandatory participation for oncology drugs and advanced therapy medicinal products (ATMPs). The primary goal is to ensure all participating countries have access to the same high-quality clinical data, thereby facilitating consistent decision-making across the EU. More specifically, JCAs aim to: 

• Streamline regulatory submissions.

  Pharmaceutical companies will submit clinical evidence once at the EU level, rather than to individual member states. 

• Harmonize clinical assessment.

  A single clinical assessment report will be used by all EU countries, potentially reducing variability in clinical evaluations to determine a product’s therapeutic value. 

• Speed market access.

  The centralized process is designed to accelerate time to market across the EU by reducing duplication of work, ensuring patients have timely access to innovative treatments. 

• Increase transparency.

  Clinical assessment reports will be publicly available, requiring careful management of data disclosure.

What key changes can the pharmaceutical industry expect?  

The implementation of JCAs brings several key changes and is expected to impact how pharmaceutical companies develop, present, and seek market access for new drugs and health technologies throughout the EU.   

• Increased focus on RWD and RWE.

  Companies will need to invest more in generating RWE to demonstrate the real-world effectiveness, safety, and value of their products. They will also need to design clinical development programs that meet the requirements of both the European Medicines Agency (EMA) and JCA simultaneously.  

• Early engagement and consultation.

  Companies will need to strategically plan for JCAs from the early stages of drug development, ensuring that their clinical trial designs and data collection efforts meet the expectations of multiple HTA bodies across the EU. Early dialogue with these bodies will be crucial for alignment on evidence requirements and to help better prepare for the assessment process.  

• Challenges in pricing and reimbursement strategies.

  While JCA focuses on clinical aspects, companies will need to prepare complementary evidence for national pricing and reimbursement decisions. Ideally, RWE will play an increased role in matching and supplementing clinical trial evidence for identifying and closing data gaps. Companies may face increased pressure to demonstrate the cost-effectiveness of their products across diverse healthcare organizations. The use of RWE to support these claims will be important in achieving favorable pricing and reimbursement outcomes. 

Clearly, RWD and RWE will be integral to the JCA process. Can you talk more about this?  

RWD and the RWE generated from the analysis of the data are vital in supplementing clinical trial data. Here are some examples of where RWE is making an impact: 

• Addressing evidence gaps.

  RWE can provide data on outcomes not captured in clinical trials, such as long-term survival or quality of life in real-world settings. 

• Comparative effectiveness.

  When direct head-to-head trials aren’t available, RWE can support indirect treatment comparisons (i.e., network meta-analyses). 

• Patient-relevant outcomes.

  RWE can offer insights into patient-reported outcomes and treatment adherence in routine clinical practice. 

• Subgroup analyses.

  RWE can help identify and characterize patient subgroups that may benefit from a treatment, supporting personalized medicine approaches. 

• Safety monitoring.

  Real-world safety data can complement clinical trial safety profiles, especially for rare adverse events or long-term safety concerns. 

By leveraging RWD and RWE, JCAs can provide a more comprehensive and nuanced assessment of new treatments and enable more informed decision-making — ultimately leading to better healthcare outcomes and more equitable access to innovation across the EU. 

Where does TriNetX fit in and how are we prepared to help address the challenges and opportunities presented by JCAs? 

TriNetX offers non-U.S. oncology RWD services to help our partners show evidence of treatment value. Collaborating with medical experts and pharmaceutical leaders, our European-based TriNetX Oncology team tailors insights for precise study objectives in oncological and rare-disease indications. TriNetX’s timely, representative, longitudinal, and deidentified European cancer care data is fit for regulatory submission and publication. 

Regarding challenges and opportunities presented by JCAs, TriNetX can:  

• Accelerate oncology and rare disease data analysis with fit-for-purpose data and insights to address specific JCA requirements. 

• Provide support in identifying and closing data gaps for JCA submissions, including mitigating issues with the population, intervention, comparator, outcomes (PICO) framework. 

Is TriNetX already doing this work? Can you provide some examples? 

The short answer is “yes”, and much of our work has been highlighted in prominent healthcare journals and publications.  

Here’s one example of how TriNetX and a pharma partner conducted a RWE external control arm (ECA) study with RWD from patients in TriNetX’s TherapyMonitor registry. The pharma company used the study to support HTA and regulatory submissions. 

About Markus Rückert, PhD 

Markus is a seasoned biopharmaceutical expert specializing in oncology and rare diseases. Proficient in clinical development and Medical Affairs, as well as experimental and RWE generation, Markus has successfully navigated various stages of drug development — from discovery to market launch — with a keen focus on advancing oncological and rare disease therapies for tangible patient benefits. Having achieved significant milestones in oncology and rare disease therapeutics, Markus now channels his diverse expertise towards broader pursuits in epidemiology, health service research, and the real-world impact of oncological treatments.