Inc.

For decades, the life sciences industry has relied on data to inform clinical best practices and help improve health outcomes. Real-world data (RWD) and real-world evidence (RWE) are necessary for research, clinical trials and development of medical solutions, support coverage decisions by payers, and identify social determinants for the advancement of health equity. 

The COVID-19 pandemic exposed inequities in existing research and patient care, prompting changes from decentralized clinical trials to increased use of RWD. 

However, diverse and representative RWD is complicated and costly to obtain and manage. Life sciences organizations need large volumes of standardized datasets on patients, disease states, demographics and comparative findings, which is why more than 80 percent of them stated their intent to enter into partnerships with data science companies this year.

With access to connected and standardized RWD, organizations can unlock answers about efficacy, cost-effectiveness or quality while providing the right patient care at the right time for all patients. 

Here are three ways life sciences organizations are using RWD. 

1. Enhance Clinical Trials

Drugs, devices and therapies can take around 10 years to create and cost upwards of $1 billion to bring to market. More than 80 percent of clinical trials in the U.S. fail to meet their patient recruitment timelines. In addition, diverse populations are underrepresented in clinical research.

“Life sciences organizations need large volumes of standardized datasets on patients, disease states, demographics and comparative findings, which is why more than 80 percent of them stated their intent to enter into partnerships with data science companies this year”

RWD and technology-enabled solutions such as artificial intelligence (AI), machine learning (ML) and natural language processing (NLP) are being used to overcome these challenges. These technologies can uncover actionable information from unstructured clinician notes to enhance clinical trial design, feasibility and execution, and improve life cycle management. 

With RWD, research timelines are compressed and solutions are delivered at reduced costs. This is accomplished by more rapidly identifying eligible trial sites and potential trial participants based on various indicators such as demographics, socio-economic and social drivers. This information was once only available to investigators through rigorous and manual chart reviews.

To increase equity in clinical trials, RWD helps to identify barriers to enrollment and develop strategies to increase clinical trial enrollment for underrepresented populations.

2. Advance Health Equity

The COVID-19 pandemic reinforced the disproportionate burden of illness, death and healthcare needs of different communities and populations. These inequities are in part a byproduct of social determinants or social drivers of health (SDoH), such as safe housing and access to healthy foods and transportation.   

In 2024, the Centers for Medicare and Medicaid Services (CMS) will begin requiring providers to screen and report on these social drivers of health. To address SDoH, researchers seek RWD that can help develop and test strategies for more equitable care. RWD about health inequities provides evidence to influence policy change, develop strategies to increase community and patient support, and improve treatments for different populations. 

3. Support Approvals and Regulations

While life sciences organizations are streamlining clinical trials and working toward equitable healthcare, they must be mindful of the changing regulatory landscape. 

Thanks to the 21st Century Cures Act, more regulatory agencies recognize the promise of RWD/RWE. When combined with clinical trial research, it can help shorten the regulatory approval process and increase the chances of U.S. Food and Drug Administration (FDA) and European Union Medical Device Regulation approvals.

Investing in RWD is crucial as payers, regulatory bodies and health systems increasingly demand proof that a medical solution delivers value by doing what it is intended to do. Health systems are shifting to outcomes-based formularies, and pharmacy benefit managers (PBMs) are conducting similar reviews, making proof of value across an entire episode of care and diverse populations required for utilization approval. 

The right RWD/RWE can not only prove efficacy and help ensure inclusion as part of the formulary, but it can also help earn waivers from payers for prior authorization or other forms of utilization management, thereby expanding the market of eligible patients and payers that will cover the cost.

Embracing Real-World Data

RWD is shifting healthcare by providing the information needed to advance health equity, better understand the efficacy, safety and cost of provider behavior change and expedite the use of existing therapies and create new treatment options.

Life sciences organizations need RWD from diverse patient populations that are accurately collected and managed and incorporate intuitive, fit-for-purpose technologies and a deep understanding of regulatory requirements.

As healthcare and medical solution developmentsevolve, the power of RWD to generate RWE will continue to prove key in improving outcomes, advancing health equity, generating patient-centred clinical trials and expediting solution time to market.