Posted: 20 Aug. 2020 10 min. read

Real-world data is changing how biopharma approaches R&D and COVID-19

By Greg Szwartz, managing director and Life Sciences data practice lead, and Andy Bolt, senior manager, Deloitte Consulting LLP

Combining real-world data (RWD) with data science could help improve the way COVID-19 is diagnosed and treated. Highly variable symptoms, uncertain treatment efficacy, and a dynamic disease landscape have created a challenging set of circumstances for biopharma research and development (R&D) organizations as they race to create diagnostics and treatments for this disease.

RWD typically includes patient information pulled from medical claims, electronic medical records, and patient-reported outcomes. Additional RWD data streams—from mobile phones, wearable devices such as fitness trackers, social media activity, and consumer purchases—are helping a wide range of life sciences and health care companies gain a better understanding of COVID-19.

When it comes to vaccines that require coordination and compliance—such as seasonal influenza shots—the US doesn’t have a great track record. Interventions that address human behavior might have as much to do with efficacy as the molecular structure of a therapy.

Can RWD and data science help answer key questions?

R&D organizations are working to find answers to following questions about COVID-19, and RWD could help them find the answers:

  • What is the natural history of this disease? 
  • How are public-health interventions (e.g., mask-wearing and social distancing policies) affecting the reproduction/transmission of the disease?
  • Where will COVID-19 patients be when I start my global clinical trial?
  • How does COVID-19 affect my existing patient populations (e.g., disease areas for which a company might already have therapies under investigation)?
  • How might health care delivery change during the COVID-19 era, and what does that mean for our clinical trials?

To address these and other complex questions under tight timelines, many R&D organizations are combining RWD with data science to make bold predictions about the future. In some ways, this COVID-19 moment is revealing the true power of RWD combined with data science.

COVID-19 has accelerated use of RWD, partnerships

In January and February of this year, the Deloitte Center for Health Solutions surveyed leaders from 17 pharmaceutical companies about their organizations’ use of RWD. Even early this year, nearly all of our respondents (94%) said they expected the use of RWD in R&D to become more important to their companies over the next couple of years. However, 70% of respondents told us that a lack of research-grade data is hindering their ability to leverage RWD in R&D, including establishing synthetic control arms.

Almost all of the company leaders we surveyed said they expect to increase investments in talent, technology, and external partnerships to strengthen their RWD capabilities. Partnering with health systems and other stakeholders could help biopharma companies improve their understanding COVID-19 and its effect on patients. A Seattle-based research institution, for example, has established a consortium of companies, health systems, and researchers to investigate the molecular mechanisms for COVID-19. Researchers plan to amass genomic, proteomic, and metabolomic data on patients to understand how the disease progresses over time and its impact on organs.1

In June, the US Food and Drug Administration (FDA) announced its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder project aimed at evaluating the diagnostic tools and medical interventions used in the fight against COVID-19. The agency is also participating in the Therapeutic Evidence Accelerator where it will share insights and compare results.2

The Observational Health Data Sciences and Informatics (OHDSI) program, a multi-stakeholder, interdisciplinary, and international collaborative, held a “study-a-thon” in March 2020 to inform global decision-making about the pandemic. The event resulted in several manuscripts, and the organization has committed to leveraging its data and capabilities to study which ongoing COVID-19 treatments are working.3

RWD is informing decisions related to clinical trial portfolios

The COVID-19 pandemic has forced many pharmaceutical companies to either delay new studies or halt enrollment in ongoing trials. Nearly one-third of clinical trial sites in the US expect COVID-19 to impact their ability to recruit patients for new trials or retain patients who are already enrolled in a study.4

Using RWD to understand the impact of COVID-19 on patient care could help clinical operations teams develop alternate strategies for existing trials. Further, it can help R&D organizations predict where future outbreaks will occur and identify possible sites for clinical trials. Organizations that have access to the right data—and the platforms needed to analyze it quickly—are likely best positioned to take advantage of RWD in this context.

While many pharmaceutical companies have been steadily expanding the scope of RWD in recent years, COVID-19 has added fuel to the fire. As the pandemic subsides, we expect companies will combine RWD with data science to improve their understanding of other diseases and to navigate the development of new treatments. While claims data offer insight into the patient’s health history, adding information about the patient’s environment could create a more holistic picture of their health and health risks.

For example, while genetics can influence diabetes and cardiovascular disease, an understanding of a person’s behavior and geography helps to build a more complete picture of each consumer and their unique health risks. Adding in movement and foot-traffic data—based on information from mobile devices—can add yet another layer of insight, which could help predict COVID-19 transmission rates. An increase in cell-phone movement around restaurants in a community might indicate that people are venturing out of their homes, which could increase the spread of the virus. This data can be much more accurate and actionable than claims data or COVID-19 test results. Moreover, internet searches about symptoms are like digital fingerprints for potentially diagnosable patients.

Society is relying on the life sciences and health care sectors to resolve this public health crisis. Those organizations will likely look to RWD and data science to help them navigate the complexity of this virus and the disease it causes. When we emerge on the other side of the pandemic, we expect the combination of RWD and data science will be used to meet future health care challenges.

Join Deloitte on September 29-30 at the Financial Times US Pharma & Biotech Summit. This year’s virtual event will explore resetting the pharma agenda in a post-COVID-19 world. Neil Lesser, principal and R&D leader, Deloitte Consulting LLP, will moderate a panel on unlocking the potential of Real-World Evidence (RWE) and Real-World Data (RWD). Learn more about the Summit, or register for free with our complimentary registration.

Endnotes

1. Merck joins Seattle consortium to uncover COVID-19's molecular workings, Fierce Biotech, April 27, 2020

2. FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts, FDA press release, June 18, 2020

3. COVID-19 updates, Observational Health Data Sciences and Informatics, accessed April 29, 2020

4. Coronavirus will have a ‘big impact’ on one-third of U.S. clinical trial sites, survey finds,” STAT News, March 2020 

Return to the Health Forward home page to discover more insights from our leaders.

Subscribe to the Health Forward blog via email