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P231: Professionals’ Perceptions on Differences Between RCT and EHR Data by Literature Review and on the Use of EHR Data by Survey

Poster Presenter

Cheryl Hergert

University of Southern California
United States

Objectives

Increase knowledge on differences between randomized clinical trial data and EHR data, and identify points to consider suggested by professionals in medical device companies when using EHR data to generate clinical evidence.

Method

Literature review of laws, regulations, books, legal briefs, FDA guidance documents, public conferences. and peer reviewed articles. Medical device professionals from multiple functions and companies of various sizes and product types were surveyed to obtain views on the use of EHR data.

Results

Approximately 400 publications were reviewed, summarized, and assessed to understand the history, development, and adoption of EHRs within HHS and the medical device industry. The sources summarized positive attributes and challenges of both data types. For example, RTCs are controlled and allow for a clear determination of results while EHR data are readily available and generalizable to a broad population. However, RCTs have shown dramatic increases in costs and may lack the ability to generalize results across a broad population. The extended length of time to conduct a RCT was also noted. EHR data have the potential for bias due to missing data and lack of quality control. Since EHR data come from multiple systems, there are challenges with integrating and validating data for both regulatory reviewers and industry. Further, treatment decisions are influenced by factors such as treatment availability, cost, and insurance coverage. Follow-ups and tests are not strictly predetermined but guided by standard of care for a patient’s medical condition. To determine if these same challenges were perceived by industry, over 400 medical device professionals were contacted and invited to participate in the survey. Of those who received the survey link; 95 individuals initiated the survey. It was determined 20% did not meet the inclusion criteria resulting in 46 (48%) surveys being analyzed. Challenges identified by surveyed professionals were similar to those discussed in literature. Main concerns with EHR data included missing data and lack of regulatory grade quality. Further, access to EHR data is somewhat limited. Respondents indicated EHR data will likely not take the place of RCTs although the number of RCTs could be reduce. Costs and timelines could be reduced and access to generalizable data could be facilitated by using data obtained from EHRs. Yet, there is reluctance to use EHR data due to a lack of diverse skills, regulatory uncertainty, and data quality.

Conclusion

Regulators consider data generated through RCTs as the gold standard. Through randomization, blinding, and control of variables, RCTs reduce bias and enhance the ability to determine if a particular intervention leads to a predetermined study outcome. Data are gathered by administering a predetermined treatment to a carefully selected group of individuals at a specific time. However, conducting RCTs has become burdensome, expensive, and time-consuming. The use of EHR data allows the findings to be more generalizable. EHR data are collected as part of routine clinical care to address the patient’s healthcare needs. The potential for bias is a concern since treatment is influenced by insurance coverage, national guidelines, and the health status of the patient. Further, EHRs are designed to obtain data reflecting patient care and cost tracking. It is common for a patient to undergo multiple treatments, consult with multiple healthcare providers, and have multiple co-morbidities. Thus, data from EHRs are often fragmented, incomplete, and disorganized due to a lack of quality assurance and interoperability. These challenges could lead to regulatory uncertainties that the industry may view as too risky. Survey respondents recommend the development of strong partnerships with data providers, enhance skills to comprehend and manage the data, and strategize and communicate with regulatory reviewers early to increase opportunity for success. The development of best practices like the harmonized GCP processes and tools would be helpful.