The Evolution and Impact of Real-World Evidence in Pharma: A Deep Dive with AKT Health

Understanding the performance of medicines in real-world settings has become pivotal in transforming the pharmaceutical industry. Real-world evidence (RWE) offers opportunities to enhance efficiency and cost savings in drug development, identify new patient populations, and drive higher profitability. Here, we explore the growing significance of RWE in the pharmaceutical value chain and key drivers behind its expansion, with a focus on AKT Health's pioneering work in decentralized clinical trials (DCTs), AI and ML, blockchain, remote patient monitoring (RPM), and real-world data (RWD) and RWE for life sciences, pharma, and biotech companies.

Positive Outcomes from RWE Implementation

Recent reports highlight several successful applications of RWE:

1. Accelerated Drug Trials: The application of RWE has reduced the sample size for pivotal phase III trials by 40%, saving six months in the process.
2. Increased Inclusivity: AI-powered analysis of real-world data has doubled the pool of eligible cancer patients for certain treatments.
3. Expanded Approvals: The FDA has accepted RWE from well-designed observational trials for new drug indications.

Key Drivers of the RWE Market

1. Enhanced Data and Advanced Analytics: The volume and variety of health data are growing exponentially, with the CAGR of health data projected to reach 36% by 2028. Integration of diverse data sets, including EHRs, pharmacy claims, and genomics, provides a comprehensive view of patient health. Spending on data products is expected to rise significantly, driven by the demand for integrated data sets and sophisticated analytical platforms.
2. Specialization of RWE Companies: As the RWE ecosystem matures, companies are focusing on oncology and rare diseases, where there is a high unmet need. These companies are investing in technical and clinical expertise, as well as advanced AI and NLP technologies, to develop tailored solutions. Specialization and strategic partnerships are leading to novel applications like external comparators and pragmatic trials, offering deeper insights for pharma pipelines.
3. Regulatory Support: Regulatory bodies, including the FDA and NICE, are increasingly supporting the use of RWE. Initiatives like the EMA's DARWIN EU project are gathering real-world data to enhance regulatory submissions and approvals. However, navigating global regulatory guidelines remains complex, prompting RWE companies to build international data sets and regulatory expertise through acquisitions and collaborations.

AKT Health: Leading the Charge in RWE and DCTs

AKT Health is at the forefront of integrating advanced technologies such as AI, machine learning, blockchain, and RPM into DCTs, RWD, and RWE. The company partners with life sciences, pharma, and biotech companies to develop innovative strategies that enhance drug development and patient care. AKT Health's comprehensive approach includes:

• Decentralized Clinical Trials (DCTs): By leveraging digital health technologies, AKT Health conducts clinical trials more efficiently and inclusively, reaching a broader and more diverse patient population.
• AI and Machine Learning: These technologies enable more precise analysis of real-world data, identifying patterns and insights that drive better decision-making in drug development and patient care.
• Blockchain: Ensuring data integrity and security, blockchain technology provides a transparent and immutable record of clinical trial data, enhancing trust and compliance.
• Remote Patient Monitoring (RPM): RPM technologies allow continuous monitoring of patients in real-time, providing valuable data that enhances RWE studies and improves patient outcomes.

Evaluating RWE Strategies

Pharmaceutical companies must continually update their RWE strategies to leverage the expanding ecosystem. Key considerations include:

• Aligning RWE needs with business objectives and asset portfolios.
• Identifying areas where RWE can provide immediate versus long-term ROI.
• Structuring RWE operations to maximize value capture.
• Comparing the benefits of internal RWE capabilities versus external vendors.
• Selecting vendors that align with specific therapeutic areas and organizational needs.

Conclusion

The rapid evolution of the RWE ecosystem is unlocking new possibilities while increasing the complexity of implementation. By updating RWE strategies and collaborating with specialized vendors like AKT Health, pharmaceutical companies can enhance drug development and care delivery, ultimately driving growth and improving patient outcomes.