As the COVID-19 pandemic has disrupted many routine medical services and discretionary surgical procedures, little attention has been paid to its impact on clinical research. Many clinical trials and other medical research activities came to a sudden halt in March when the World Health Organization declared COVID-19 to be a pandemic.
Regents Professor John C. Licciardone is a board-certified physician in Public Health and Preventive Medicine and Director of the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) at the University of North Texas Health Science Center. He discusses how the PRECISION Pain Research Registry has maintained ongoing clinical research operations during the COVID-19 pandemic, including performance of its OPTIQUAL Trial.
What is the PRECISION Pain Research Registry?
PRECISION is a national registry that enrolls and studies participants with chronic low back pain. Its research emphasizes the biopsychosocial aspects of chronic pain and studies precision medicine to help improve health-related quality of life. The initial stages of development occurred from 2016 to 2018, when registry infrastructure and staffing focused on conducting quarterly in-person research visits in the Dallas-Fort Worth metroplex. However, as a member of the Work Group that developed the Federal Pain Research Strategy, it became evident that a national registry was a top priority in advancing the field of pain research. PRECISION adopted a digital technology platform in 2019, thereby facilitating its transition to a national pain research registry.
Why has PRECISION been able to operate during the COVID-19 pandemic?
Our digital technology platform is used to manage all aspects of the research process when prospective participants approach the registry in response to national recruitment efforts via social media. Prospective participants complete a brief online survey and eligible participants are then invited to enroll by completing an online informed consent document. After giving consent, participants receive a hyperlink to complete the baseline research forms and receive a saliva collection kit via courier service for subsequent genetic analysis. Participant compensation is then provided using a debit card system and subsequent quarterly research encounters are scheduled electronically. These research processes have not been impacted by the COVID-19 pandemic.
Has registry enrollment declined during the COVID-19 pandemic?
No, the enrollment rate has actually increased during the pandemic, and is now approaching 1000 registry participants. In part, this is because the geographic reach of the registry was recently expanded from Texas to the contiguous 48 states and District of Columbia. However, the research team thought that some people may have more free time during the pandemic shutdowns to participate in the research regsitry. The research team is also beginning to assemble an affiliated national control panel of participants without chronic pain to enhance its research capabilities.
How do you conduct a clinical trial during the COVID-19 pandemic?
The ongoing randomized controlled trial, entitled "Optimizing Chronic Pain Management through Patient Engagement with Quality-of-Life Measures" exemplifies how our registry can be used to conduct clinical research during the COVID-19 pandemic. The intervention in this trial involves an educational tool that is immediately sent electronically to the experimental group and then later to the control group following completion of the trial. The intervention, study outcomes, and all other research data are based on "patient-reported" measures that do not require in-person research encounters. Such patient-reported measures are commonly used in pain research and other fields.