July 2, 2021

Data sourcing can be challenging. Identifying optimal data sources requires extensive insight into the data landscape relative to specific research needs.  Successful data sourcing will require a balancing act between research priorities and data availability.  A large majority of data collected during patient care are unavailable for research purposes. This can be attributed to a variety of reasons:

1. Provider/health system policies require data to remain firewalled within the electronic medical system.

2. Poor system design creates challenges in extracting HIPAA-compliant data, this is particularly true for diagnostics and laboratory results which are stored as PDF/image file attachments in patient medical records.

3. Variations in standard of care; tests which may be considered standard by clinical guidelines/KOLs are not generally adhered to in the real world.

The combination of these elements greatly impact the availability of outcomes data.

While Electronic Medical Records (EMR) may be considered by some as the holy grail for outcomes research—not all are created equal. One must consider the primary settings of care from which the data is collected when selecting an EMR source for retrospective research.

For example, EMR data collected from urgent care clinics and primary care offices may include patients with a variety of different diseases.  However, when examining these data for disease-specific clinical results or Patient Reported Outcomes (PROs), data availability is limited since these types of data are not collected in these settings of care.

At the same time, disease-specific EMR/registry data collected from specialty care providers can be excellent sources of PRO data. While valuable, there are often tradeoffs related to insights on comorbidities, non-specialist care, and limited availability of large sample sizes.

At STATinMED Research, we understand the data landscape environment and as a part of our complimentary data advisory service we will work with you to identify the most appropriate data source(s) and study designs for your evidence needs.

Keshia Maughn, MPH
Vice President / Principal
Real-World Evidence

Keshia Maughn, MPH, has in-depth skills and experience in managing outcomes research projects across therapeutic areas including oncology, immunology, women’s health, neurology, and endocrinology. With over 10 years of experience in the application of real-world evidence for advanced analytics projects, Ms. Maughn has led a global research team in HEOR and Market Access engagements. She has vast experience in econometrics and supervised machine learning techniques on a variety of data sources including open and closed network claims data, EHR data, laboratory, and genomic data. Ms. Maughn is a subject matter expert in the methodology design and the application of machine learning to provide the evidence necessary to support value communications.

As real-world evidence authorities, STATinMED Research discovers data, develops insights and delivers optimal solutions to help life science companies realize maximum value. 

Many thanks again to you and the entire STATinMED Research team for your help with the cohort comparison and timeline. It means a lot to us.

— Oncology Global Patient Outcomes Executive Real World Evidence at global biopharmaceutical company

We understand real-world evidence and solve problems with confidence. Contact the STATinMED Business Development team to learn more!