– Written by Alok Anand, Global Presales & Solutions Head – Healthcare & Life Sciences Practice at Harman DTS (A Samsung Company)

In the ever-evolving landscape of drug discovery, the integration of real-world evidence (RWE) has emerged as a game-changer. As we navigate the challenges of traditional drug development processes, the infusion of RWE is creating a profound impact on the identification, validation and optimisation of drug candidates.

This blog post delves into how real-world evidence is revolutionising drug discovery and offering insights that transcend the boundaries of controlled clinical trials.

Real-World Evidence in Drug Discovery

Drug discovery, with its focus on data-driven innovation, is uniquely positioned to leverage the power of real-world evidence. Unlike traditional clinical trials conducted in controlled environments, RWE draws insights from real-life experiences of patients and provides a comprehensive understanding of a drug’s effectiveness, safety and impact in diverse populations.

1. Accelerating Target Identification: It often takes traditional drug discovery processes 5–7 years to identify and validate a target. Real-world evidence, integrated into the drug discovery framework, enables researchers to tap into existing health records, genetic data and patient outcomes, potentially reducing the time required for target identification.
2. Enhancing Clinical Trial Design: RWE plays a crucial role in designing more accurate and efficient clinical trials. By analysing data from diverse patient populations, researchers gain insights into the variability of drug responses, which helps refine inclusion criteria and optimise trial protocols.
3. Validating Drug Efficacy and Safety: The rich datasets derived from real-world evidence contribute to a more comprehensive understanding of a drug’s efficacy and safety profile. This is particularly significant in uncovering long-term effects, rare adverse events, and interactions with coexisting conditions or medications.
4. Increasing Candidate Suitability for Clinical Trials: Traditional drug discovery results in suitable candidates for clinical trials only 50% of the time. By integrating real-world evidence, drug discovery has the potential to identify and validate candidates with higher success rates – potentially 90%.
5. Reducing Time and Costs: Real-world evidence facilitates a more streamlined drug discovery process, which could reduce the time and costs associated with clinical trials. By leveraging existing data sources, researchers can expedite decision-making and enhance the overall efficiency of drug development.

Real-World Evidence in Numbers

Challenges and Opportunities

While integrating real-world evidence brings unprecedented opportunities to drug discovery, it also poses challenges. Data quality, standardisation and privacy issues require careful consideration. Collaborative efforts, technological advancements and the development of robust analytics are crucial in harnessing the full potential of RWE.

Typical Challenges

1. Data Quality and Standardisation: Real-world evidence often comes from diverse sources such as wearables, consumer data, biomarker data, mortality data, pharmacy data, claims data, survey data, EHR data and disease registries. This leads to variations in data quality and standards. Ensuring the data is consistent and accurate is a significant challenge, as different healthcare systems use different formats and terminologies.
2. Data Privacy and Security: With the integration of real-world data comes the responsibility to safeguard patient privacy. Maintaining compliance with data protection regulations and implementing robust security measures is crucial for ensuring ethical use and preventing unauthorised access.
3. Integration of Diverse Data Sources: Real-world evidence spans electronic health records, claims data, genetic information and patient-reported outcomes. Integrating these diverse data sources into a cohesive and meaningful manner poses technical and logistical challenges that need to be addressed for a holistic understanding of patient experiences.
4. Bias and Generalisation: Real-world data may contain inherent biases based on factors such as patient demographics, geography and access to healthcare. Overcoming these biases and ensuring the generalisability of findings to broader populations is essential for the reliability and applicability of real-world evidence in drug discovery.
5. Lack of Standardised Methodologies: Unlike controlled clinical trials, real-world evidence lacks standardised methodologies for data collection and analysis. Developing consistent and widely accepted methodologies is crucial for generating reliable insights and comparisons across studies.

Opportunities

1. Expanded Patient Representation: Real-world evidence allows for the inclusion of a broader spectrum of patients, including those with comorbidities, diverse demographics and varying genetic backgrounds. This inclusivity enhances the external validity of findings, leading to more personalised and universally applicable drug discoveries.
2. Enhanced Clinical Trial Design: Leveraging real-world evidence in clinical trial design enables researchers to optimise protocols based on a deeper understanding of patient experiences and variability. This can lead to more efficient trials with improved patient outcomes and reduced resource expenditure.
3. Longitudinal Insights: Real-world evidence offers longitudinal insights into patient journeys and a comprehensive understanding of the long-term effects and outcomes associated with a particular drug. This extended view is valuable for assessing the sustained efficacy and safety of treatments over time.
4. Cost Savings and Resource Efficiency: Integrating real-world evidence can potentially reduce the time and costs associated with drug discovery. By utilising existing data sources, researchers can expedite decision-making processes, identify suitable candidates for clinical trials more efficiently and streamline the overall drug development pipeline.
5. Real-Time Monitoring and Adaptive Strategies: Real-world evidence allows for real-time monitoring of patient responses and facilitates adaptive strategies in drug development. This dynamic approach enables researchers to adjust trial designs and treatment strategies based on emerging data, which leads to more responsive and effective drug development.
6. Post-Market Surveillance: Real-world evidence plays a crucial role in post-market surveillance, helping identify rare adverse events, long-term effects and variations in drug responses across diverse patient populations. This information contributes to ongoing safety assessments and regulatory decisions.

While challenges exist in harnessing real-world evidence for drug discovery, the opportunities it presents are vast and transformative. Addressing data quality, privacy concerns and standardisation issues is paramount, and collaborative efforts between researchers, healthcare providers and regulatory bodies are essential for unlocking the full potential of real-world evidence in shaping the future of drug development.

Real-world evidence is not just a supplement to traditional drug discovery; it is a catalyst for transformative change. As we embrace drug discovery, fuelled by data-driven insights, the impact of RWE becomes increasingly evident. Amalgamating diverse data sources from real-world settings propels us towards a future where drug discovery is not confined to controlled environments but extends into the realm of real-life patient experiences. This paradigm shift holds the promise of not only accelerating the drug development process but also delivering safer, more effective and personalised treatments that cater to the needs of diverse patient populations.