How Real-World Data Is Changing Healthcare and Pharma

With the advent of digital transformation and iterations of AI revolutionizing every industry, new forms of intelligence have emerged: real-world data (RWD) and real-world evidence (RWE). Within the healthcare space, these developments are driving major investments from large-scale pharmaceutical companies and health organizations. But what are RWD and RWE, exactly?

Real-world data is data relating to patient health status and the delivery of health care routinely collected from a variety of sources. In other words, it’s data that comes from outside the clinical research setting, aka electronic health records, disease and product registries, claims and billing data, as well as data from “wearables” and health monitoring devices. Real-world evidence is the product of analyzing the above-mentioned types of data.

RWD is drumming up palpable excitement within the industry, as evidenced by the over 23% increase in documents mentioning “RWD” over the last 30 days within the AlphaSense platform. But what opportunities do RWD and RWE hold for pharma and healthcare companies? Below, we dive into the key use cases for these new forms of data, existing sources for RWD, and the growth of RWE clinical trials.

Use Cases

Since the FDA issued its guidelines on real-world evidence in January 2022, executives have been strategizing how their organizations should invest in RWD. The COVID-19 pandemic illustrated both the benefits and drawbacks of real-world data, bringing to light the complexity and capabilities it possesses.  

Advocates point to the benefits of real-world data, including availability, efficiency, and generalizability. However, skeptics argue that, with a new regulatory environment, the quality, validity, reliability, relevance, costs, and provenance of the data could be questionable. Regardless of what side you take in this debate, the stakes are getting higher on real-world data investment decisions—data is getting more expensive to acquire, curate, and protect, so it’s important to understand how RWD is being leveraged.  

Regulators take RWE data into account, which has the potential to impact approvals and accelerate the drug development process. This could save drugmakers a lot of money at a time when cutting costs is critical. Searching across Stream in AlphaSense’s expert call library, we’ve noticed more industry experts are conveying the importance of real-world data in today’s healthcare landscape.

“Real-world data [and] real-world evidence is becoming extremely important, especially more so in the R&D side of looking at clinical trials and leveraging real-world data to look at alternate indications or even accelerate a study.”

– Former President of EVERSANA | Expert Call

Additionally, real-world evidence complements clinical trial data by providing insights that trials simply cannot (i.e., safety and effectiveness data from a patient’s daily life). That’s why insurance companies and other stakeholders must have a solid understanding of what benefits a drug offers to patients, as RWE can help bolster their confidence in a treatment’s effectiveness.

Existing Databases of RWD

A myriad of databases have emerged that collate the growing volume of RWD, ranging from physician and patient survey data, costs, medications, and procedures, laboratory results, and outcomes, as well as demographic and socioeconomic status. While capital is being funneled into establishing new databases, there’s a slew of existing RWD databases that sector leaders can take advantage of:

• The Sentinel Initiative: This is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. In response to the FDA Amendments Act (FDAAA) of 2007, the FDA launched the Sentinel Initiative in May 2008.

• The Electronic Health Records for Clinical Research Project (HER4CR) Project: HER4CR is aimed at improving the design of patient-centric trials through a platform that provides access to existing patient electronic health record systems (EHRs). Launched in 2016, HER4CR enables scientists to find suitable candidates for trials by searching millions of EHRs throughout Europe while maintaining patient privacy.

• PatientsLikeMe: This is an online platform where hundreds of thousands of members get advice for their conditions from fellow patients, compare treatments, symptoms and side effects, and track their own personal health data in real-time.

• The Accelerated Cure Project Repository: This is a massive collection of biological samples and data from people with MS, to help researchers and hopefully lead to new breakthroughs.

The Growth of RWE Clinical Trials

Pharma companies are finding that RWD data can play a role in all stages of the drug development process, from early discovery to post-market. For the clinical trial stage, real-world evidence can offer valuable observational data that a traditional trial simply cannot provide. As a result, real-world evidence studies have been growing steadily over the past few years.

According to the GlobalData Clinical Trials database, there were 194 real-world evidence trials in 2021—the highest annual number recorded since 2019 (160 trials). Data shows a consecutive upward trend in RWE trials, except for 2020 where there was a small decrease, as many studies were delayed due to issues with patient recruitment and site closures because of global lockdown measures.

Real-world evidence studies have become increasingly popular due to the efficiency and accuracy of real-world data. RWE studies have been shown to aid in clinical planning, participant recruitment, trial design, and post-marketing surveillance. Healthcare costs can also be reduced by patient personalization, early diagnosis, and remote patient monitoring within trials. And with regulatory authorities like the FDA and European Medicines Agency (EMA) actively promoting the use of RWE trials, it’s likely the industry will see an increase in the number of these studies.

Emerging Challenges of RWE and RWD

Researchers are finding that real-world data and evidence pose challenges in their utilization, ranging from data privacy and standardization to the need for advanced analytics. Ultimately, interpreting vast datasets requires a nuanced understanding of both technology and clinical context—a reality that most pharma and healthcare institutions are actively grappling with today.

Data Regulation Compliance: Healthcare entities must adhere to regulations like HIPAA and General Data Protection Regulation (GDPR) to address data privacy. For example, when analyzing patient data from EHRs, companies must anonymize the data to comply with HIPAA by removing any identifying information. Similarly, under the EU’s GDPR, companies must obtain explicit consent from patients before using their data, ensuring transparency about data usage.

Establishing Standardized Practices: Developing common data collection and analysis standards through industry-wide dialogue is crucial for standardization. This enhances data quality and facilitates broader research. For instance, the use of common data models like OMOP is gaining traction, harmonizing diverse data sources and ensuring consistency and reliability in RWE studies. Healthcare companies should actively participate in shaping these standards to align with clinical needs and research objectives.

Understanding the Data: Interpreting complex datasets requires a blend of technology and human expertise. Healthcare companies should build teams proficient in data science and clinical practice. Establishing multidisciplinary teams of data scientists, clinicians, and ethicists can ensure projects are technically sound and ethically and clinically relevant.

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