Healthcare is immersed in a wealth of invaluable data. Every aspect, from patient records and diagnostic tests to treatment plans and medical trials, generates information that holds immense potential for advancing patient care. The sheer volume and diversity of this data are expanding rapidly, with the compounded annual growth rate (CAGR) projected to hit 36% by 2028.
Understanding how medications perform in real-world scenarios can revolutionize the pharmaceutical industry. It can drive efficiencies in drug development and identify new patient populations for existing treatments, ultimately leading to increased profitability and shareholder returns.
However, pharmaceutical leaders must effectively harness RWD and RWE to establish a lasting competitive advantage in an evolving landscape. To begin, it's essential to grasp the fundamental concepts of RWD and RWE.
What is RWD and RWE?
Randomized controlled clinical trials (RCTs) have traditionally served as the benchmark for establishing the effectiveness and safety of pharmaceuticals. In these trials, drugs are given to meticulously chosen participants who are closely observed for both therapeutic effectiveness and any adverse reactions.
However, once a drug gains approval, it is introduced to a much broader patient demographic, encompassing individuals of varying races or ethnicities, wider age ranges and diverse medical conditions. The information gathered from the real-world application of these drugs is termed real-world data (RWD), comprising data from:
Electronic health records (lab results, treatment plans and radiology images)
Disease and product registries (Alzheimer’s Prevention Registry, Genome Connect, Rare Disease Registry Program)
Claims and billing data (data from health insurance companies that includes information about procedures and demographic information)
Patient-generated data from “wearables” and health monitoring devices (heart rate tracking from an Apple Watch or Fitbit)
Patients’ health status and outcomes data from (Image data, lab, molecular profiling (genetic testing), digital biomarkers, family history, long-term care)
Real-world evidence (RWE) comes from analyzing the above-mentioned types of data. Real-world data combined with analytics equals real-world evidence.
Efficacy-effectiveness gap
The efficacy-effectiveness gap underscores the importance of bridging the divide between clinical trial results and real-world outcomes. While randomized controlled trials remain essential for establishing initial drug efficacy, understanding how drugs perform in the real world is equally crucial. The divergence between idealized trial conditions and real-world use can lead to unexpected efficacy issues or adverse effects, highlighting the need for a comprehensive approach to evaluating drug performance.
The pharma landscape
Pharmaceutical companies are increasingly recognizing the potential of RWE to enhance decision-making and drive value across the product lifecycle. Examples abound, such as Pfizer's successful use of electronic medical records to gain approval for treating male breast cancer and AstraZeneca's demonstration of its diabetes treatment's effectiveness through real-world data. McKinsey estimates that embracing RWE could unlock substantial value for pharmaceutical firms, potentially exceeding $300 million annually for top players.
How IT companies can help
In this landscape, IT companies play a pivotal role as strategic partners, leveraging their expertise in data integration, analytics and technology infrastructure. By enabling pharmaceutical companies to harness diverse sources of real-world data, IT firms facilitate the generation of actionable insights for drug development, safety monitoring, and market access strategies. Moreover, they ensure compliance with regulatory standards, providing secure and scalable technology solutions for RWE generation and submission.
Through collaborative partnerships and innovative solutions, IT companies contribute to advancing evidence-based healthcare and fostering innovation in the pharmaceutical industry. By empowering stakeholders with the tools to harness the full potential of RWD and RWE, these partnerships pave the way for improved patient outcomes, streamlined drug development processes, and enhanced healthcare decision-making.
The era of real-world data and evidence heralds a transformative shift in healthcare, offering unprecedented opportunities for innovation and value creation. As pharmaceutical companies embrace RWE as a cornerstone of their strategic approach, collaboration with IT partners will be essential to unlocking its full potential and driving sustainable growth in an evolving landscape.
