In an era where Real-World Evidence (RWE) is revolutionizing clinical trials, our interview with Tina Marshall, a key figure at Akrivia Health, offers invaluable insights. This discussion delves into the challenges and potential of RWE in clinical trials, particularly in accessing and utilizing NHS clinical trials data. Tina Marshall’s expertise sheds light on how innovative solutions are transforming the way clinical trials are conducted and managed, highlighting the unique position of the UK in the global healthcare landscape.

Moe Alsumidaie: Tina, could you elaborate on the challenges clinical operations personnel face in trial data management and how novel solutions can overcome traditional methods?

Tina Marshall: NHS clinical trials data management isn’t our primary area; however, we focus on using real-world data in clinical trials. The main challenges are developing protocols, understanding patient characterization, and disease burden. In the UK, most data is unstructured, unlike the US, where structured coded data is available due to billing. The key challenge is identifying patients from a massive volume of free text in electronic patient records. Our solution, Akrivia Synapse™, an AI-driven data enrichment tool, addresses this by extracting critical information from this data, aiding in precision patient identification and reducing screen failure rates.

Moe Alsumidaie: How can real-world evidence (RWE) most effectively inform clinical trial endpoints and play a role in innovative data analytics?

Tina Marshall: RWE is crucial for providing a comprehensive view of a patient’s journey. For instance, in the UK, NHS numbers track patients from birth, offering longitudinal data critical for understanding diseases like dementia or Alzheimer’s. This data helps develop disease-modifying medications and gives pharma organizations the opportunity to develop a digital twin with as much phenotypic data as possible, to help understand what is happening with patients, which is invaluable for drug development and patient care.

Moe Alsumidaie: How can stakeholders across the healthcare spectrum, like regulators, payers, patient groups, and pharma, collaborate to leverage RWD for improved outcomes?

Tina Marshall: Collaboration stems from understanding and exploring the depth of data available. Many recognize the benefits of RWE, but the challenge lies in comprehending its depth. We provide a detailed view of patients’ history, which aids in patient characterization, understanding of disease burden, resource utilization, and so much more. This information is pivotal for developing targeted product profiles and recruiting for trials.

Tina Marshall Akrivia Health

Moe Alsumidaie: What are the significant barriers to the broader adoption of RWE in the biopharmaceutical industry, and how can these be addressed?

Tina Marshall: As I have mentioned earlier, the primary barrier is the lack of understanding of the depth of data RWE can provide to some organizations. There is a general awareness of RWE’s benefits, but many don’t realize the extent of the detailed information it can offer. This knowledge gap needs addressing to leverage RWE for drug development and clinical trials fully.

Moe Alsumidaie: How do you assess the current landscape of RWE in regulatory decision-making, and what shifts do you anticipate in regulatory attitudes towards RWE?

Tina Marshall: There’s already a positive shift towards RWE in regulatory bodies. The UK, aiming to become a life sciences superpower, increasingly recognizes the importance of RWE. It offers ethical advantages in trials, especially for conditions like schizophrenia or bipolar disorder, where using placebos is problematic. Regulators recognize RWE as a means to bring more clinical trials to the UK effectively.

Moe Alsumidaie: Is there anything else you’d like to add?

Tina Marshall: It’s essential to view the UK as a key player in clinical trials. We have a diverse population, longitudinal data, and a digitally mature healthcare environment that many nations lack. The UK is working hard to streamline approval processes and integrate RWE, making it an attractive location for conducting clinical trials.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.