Authors: Reynolds M, Petruski-Ivleva N, Samant M, Dreyer N, Trivedi V, Green A, Graff J.
IQVIA, April 26, 2021
This white paper provides key health care stakeholders, including clinicians, researchers, payers and regulators, with a broad view of how the COVID-19 pandemic may have impacted real-world data (RWD) collection and research. Beyond COVID-19, researchers are considering how RWE, using data from routine patient care, can complement evidence generated by clinical trials. Because randomized controlled trials answer only a small subset of the clinical and economic questions, the hope is that high-quality RWE — when done with high-quality data and good research methods — can fill gaps in knowledge and inform routine care and coverage decisions. High-quality data and good RWE research methods have the potential to improve decision-makers' trust in and acceptance of RWE results.
The study highlights key areas that researchers should be critically thinking through when designing, analyzing, and interpreting real-world studies using data collected during this pandemic. Despite increased urgency and use of RWE during the pandemic, many still doubt future use due to data gaps that the pandemic has created. Lack of clarity on how to handle these disruptions creates the risk that decision-makers may disregard any real-world evidence (RWE) studies that include data collected during the COVID-19 pandemic — creating a lasting impact on the acceptance and use of RWE in the years to come.
The uncertainty brought on by the COVID-19 pandemic has dramatically shifted how and when patients decide to seek medical care. In addition, shifts in health care coverage and provision during the pandemic have changed the discovery and reporting of certain outcomes in data and the treated population. This means that disease trends may lead to incorrect interpretations when RWD and RWE are not framed in the context of the pandemic and long-term COVID-19 diseases, therapies and lifestyle changes. The following were identified as key concerns affecting RWD and research due to the pandemic:
- Shifts in treatment seeking behavior
- Impact on near-term outcomes
- Impact on long-term outcomes
The authors suggest steps that real-world research can take to account for the pandemic, such as:
- Describe the population of interest at different time points relative to the pandemic to put results in the context of those who are seeking care.
- Arrange analyses by time-period and type of care received, restricting the data to a certain type of care, or handling the data collected during the pandemic separately from previous years to address the effects of the pandemic on health outcomes.
- Consider if bias may exist in your study population due to the differences of the impact of the pandemic on certain sub-populations.
- Include additional factors, such as type of care received, diagnosis or evidence of prior or current COVID-19 infection, geographic location of patients, and anything else impacted by a COVID-19 infection.
- Include alternative study endpoints or definitions of outcomes to address differences in data pre-and post-pandemic.
- Use the Good Research for Comparative Effectiveness (GRACE) Checklist as a tool to assess the robustness and quality of RWE generated in a post-COVID era.