Date: July 30, 2008
Contact: Maggie De Pano
Duke Clinical Research Institute

Researchers should study more patients in emergency care settings to improve the quality of acute and disaster care, the Institute of Medicine stated in a 2006 report. Emergency Departments (EDs) are good research venues because they treat a high volume of patients, many of whom are typically underrepresented in medical research. Several factors, however, make it difficult to enroll ED patients in clinical studies.

Duke investigators examined research participation in a large, academic ED and found that overall, ED patients were enrolled in clinical studies at a rate that compares favorably to those reported for other outpatient clinical settings. Many eligible minorities, children and seniors, however, were not enrolled.

The study appeared in the June 2008 issue of the Annals of Emergency Medicine and was co-authored by Laura M. Beskow, PhD, assistant research professor with the Duke Institute for Genome Sciences and Policy and Associate Director of the Duke Translational Medicine Institute’s Ethics, Law & Policy Core.

The study authors noted that enrolling children, seniors and minorities in clinical studies presents several unique challenges. These include getting parental permission before children can participate, dealing with altered mental states and lack of surrogate proxies among seniors, and overcoming trust issues and language barriers among minorities.

The team screened 4,410 patients for eligibility to participate in one of seven studies that required a low volume blood draw. Of these, 1,202 met the criteria for enrollment, of which 868 were able to voluntarily give or not give consent. Investigators eventually signed up 639 patients for an overall enrollment rate of 53.2 percent. The distribution of enrollment between male and female patients was similar, with about half of approximately the same number of eligible males and females participating.

White patients had the largest percentage of enrollment (58.3%), followed by black patients (49.2%), and then Latinos (18.4%). Patients aged 18 to 64 years had the highest enrollment rate (55.5%), followed by seniors (49.1%), and then children (40%). The authors cited patient refusal as the most common reason for non-enrollment, followed by operational issues such as a lack of foreign language translators.

Federal regulations allow for research without informed consent, the authors noted. Provisions such as waiver of requirement of informed consent for minimal-risk studies and exception from informed consent for emergency research exist. However, investigators currently do not use waivers and exemptions extensively in emergency care settings.

The authors suggested that studies which do not put patients at incremental risk, such as the seven studies they examined, should be considered for minimal-risk waivers to prevent delays in getting approval for research studies. They also encouraged researchers to conduct more ED-based research, as new data could help reduce disparities in the development and application of acute and emergency care.

Other Duke investigators include lead investigator Seth W. Glickman, MD; Kevin J. Anstrom, PhD; Li Lin, MS; Abhinav Chandra, MD; Daniel T. Laskowitz, MD; Christopher W. Woods, MD; Debra H. Freeman, RN; Monica Kraft, MD; Laura M. Beskow, PhD; Kevin P. Weinfurt, PhD; Kevin A. Schulman, MD; and Charles B. Cairns, MD.