This article was written by Nandini Selvam, PhD, MPH, President, IQVIA Government Solutions.
Real world data (RWD) and real world evidence (RWE) are increasingly proving their worth across a wide range of public health-related activities – including the tracking of infectious diseases such as COVID-19 and monkeypox, post-marketing safety surveillance of medical products, coverage decisions, and the design of clinical trials and observational studies.[i] As diversity, equity, and inclusion (DE&I) initiatives gain ever more attention, RWD and RWE can also support efforts to monitor social determinants of health, such as Healthcare access and quality.[ii]
RWD can help Government agencies at all stages of their data journey
Abundant RWD, from electronic health records (EHR), administrative claims, and other observational information generated routinely at pharmacies, laboratories, and clinics can support a wide range of public health efforts. And many tools are available to strengthen public health infrastructure for data processing, real-time decision making, and monitoring. Entities such as hospitals, payors, data integrators, and medical-record software suppliers are already paying for much of the necessary infrastructure. These can help Government agencies at all stages in their journey to acquire, link, tokenize, de-identify, standardize, manage, store, and analyze their data.
One example of successful application of RWD in support of Federal emergency response and recovery efforts took place when Hurricane Maria struck Puerto Rico in September 2017.[iii] Real world data was used in near real time to support the island’s medication needs. At that time, 71 percent of its pharmacies were closed, resulting in many residents of Puerto Rico losing access to much needed medication. To address this situation, the Centers for Disease Control and Prevention (CDC) leveraged details on prescription patterns and drugs dispensed by retail facilities in Puerto Rico from a trusted database.
Within an hour, the CDC was provided with a list of the top 200 medications dispensed by retail facilities across Puerto Rico, representing 80 percent of all prescription drugs dispensed by these facilities. The information was given to the U.S. Department of Health and Human Services’ (DHHS) emergency response team, allowing the transfer of appropriate medications to the island and ultimately saving lives.[iv]
Near real-time data can help Government agencies plan for and respond to other such emergencies. This can enable them to mitigate impacts more quickly after a disaster. Actions might include identifying which beneficiary populations are losing access to therapies – such as chemotherapy or insulin treatment – and whether access to care is improving as a result of any emergency rules.5
To date, the U.S. Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Office of the Assistant Secretary for Planning and Evaluation (ASPE), CDC, and National Institutes of Health (NIH) have leveraged RWD address various aspects of the opioid epidemic. Additionally, the CDC, FDA, and ASPE have incorporated RWD to:
- Examine the impact of COVID-19 on mental health outcomes
- Monitor prescribing trends for anti-retrovirals, antibiotics, opioids, and more
- Enable outreach to high-volume antibiotic prescribers for antibiotic stewardship
- Identify ‘hidden health epidemics’ unfolding in the shadow of COVID-19
- Track the progress of influenza and COVID-19 immunization
- Develop case-identification algorithms for multiple sclerosis and Parkinson’s disease prevalence estimates6
Real world data can support improved patient access to care
In addition to global disease and pharmaceutical surveillance, RWD can lead to actionable ways to advance patient access to care, such as improving patient and provider engagement through digital health innovations, and establishing provider networks. These solutions can optimize Healthcare performance measurement through myriad approaches: demonstrating treatment value, supporting cost management, optimizing use of Healthcare delivery resources such as staff and equipment, identifying drivers of adherence to provider treatment guidelines, and helping with Healthcare master data management efforts.
The entire drug development cycle can benefit from RWD, including all phases of clinical trials, setting up and maintaining patient registries, and enabling faster and better predictive analytics methodologies. Finally, various research studies can be advanced in areas including health economics and outcomes research, and data analysis around patient and policy impact.
Embracing RWD resources will advance public health for all
Many helpful resources exist to support the efforts of public health researchers and officials, in line with various FDA guidances supporting the use of both RWD and RWE.8 ,9,10,11 Embracing broader use of real world data will advance a more accurate understanding of trends and effective interventions when diseases emerge. If harnessed at scale, the data can provide a sustainable public health resource for the benefit of all.
Visit the IQVIA booth (#709) at the American Public Health Association Annual Meeting and Expo 2022 (APHA) on November 6-9, 2022. More details of IQVIA’s U.S. Government Solutions can be found here.
[iv] Lavery AM, et al. Notes from the field: pharmacy needs after a natural disaster—Puerto Rico, September–October 2017. Morbidity and Mortality Weekly Report. 2018 Apr 6;67(13):402. Available from: https://www.cdc.gov/mmwr/volumes/67/wr/mm6713a4.htm
About Dr. Nandini Selvam
Dr. Nandini Selvam has 20+ years of experience in epidemiology, surveillance, domestic and global health policy, project management and implementation, profit and loss, and strategy development in pharma, payor, consulting, Government, and academic settings. She is an experienced epidemiologist with a background working across disease and therapeutic areas: vaccines and infectious and chronic disease.
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections to deliver powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve Healthcare outcomes for patients. With approximately 82,000 employees, IQVIA conducts operations in more than 100 countries. Learn more at www.iqvia.com.