CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Gregory A. Folz, CCRP, administrative director, Research Institute of Deaconess Clinic in Evansville, Indiana, a finalist for the Society for Clinical Research Sites’ 2015 Site Patient Recruitment Innovation Award (SPRIA), which recognizes sites that employ innovative patient recruitment strategies.
Q: Tell us about the research functions added to an existing Electronic Medical Record (EMR) system at Deaconess Clinic. How have they helped improve clinical trial recruitment and enrollment?
A: The time constraints and demands on physician practices are at an all-time high. If the physician is also an active clinical investigator, it’s even tougher. Our investigators were engaged in the oversight of their clinical trials, but their direct support of patient recruitment was often very limited. We estimated that this limited support could cost a study upward of 50% of its potential optimal enrollment. In addition, the Center for Information and Study on Clinical Research Participation (CISCRP) has found that three times as many patients prefer to hear about clinical trials from their physicians than from promotional ads or flyers. As the “gatekeepers” for clinical trials, it just made sense to focus on a solution from the physician’s perspective.
A needs assessment of our investigators and referring physicians determined that increased functionality of the existing EMR for research purposes could make it easier for them to identify and refer potential study subjects. We developed a number of technical enhancements for our EMR system to allow investigators to expedite the pre-identification of patients who fit study criteria. Eligible patients are then flagged on physicians’ daily schedules so that the physicians can be prepared to talk about study opportunities during patient appointments. The daily schedule reminders are customized for each physician depending on their preferences and practice style. The system also allows investigators and referring physicians to directly refer their patients to actively enrolling trials through the EMR, similar to the process used for making a specialty or ancillary referral, as opposed to submitting referrals written on paper.
The enhanced EMR technology was integrated with traditional recruitment tactics, including database mining, direct-to-patient activities and physician-to-physician education efforts.
Our first study with the new EMR research functionality generated 157 patient referrals from 34 physicians in our organization, resulting in more than triple the expected enrollment. Today, our average enrollment rate across all clinical trials is 122%, up from 72% just 18 months ago.
Q: From a site’s perspective, how could the challenges of patient recruitment and enrollment be addressed?
A: The consolidation and practice acquisition that has occurred, and continues to occur, in the healthcare industry provides a tremendous opportunity for the research industry. Consolidation is creating massive, dynamic portals of patient populations overseen by growing groups of employed or contractually affiliated primary care and specialty care physicians. Most of these organizations already have robust EMRs to manage the care of these patients and maintain their extensive medical information. Developing stronger relationships with these organizations, and possibly their EMR vendors, could help sponsors and/or CROs pre-identify significant pools of eligible patients targeted for clinical programs. In return, sponsors and/or CROs would prove these organizations with access to promising treatment alternatives, as viable care options, to improve the health of the patient populations they manage.
Q: Are there specific ways that CROs and sponsor companies could better support sites in their patient recruitment efforts?
A: On average, industry experts have found that a significant majority of patients enrolled in industry-sponsored trials today come from within the physicians’ practices. There are sites that may enroll a considerably higher percentage of their patients from within and there are sites that may rely heavily on external sources. However, most sponsors and/or their CROs continue to deploy the same support across all sites.
Sponsors and CROs should provide recruitment support matched to the particular needs of the sites. The sponsor’s site selection process requires sites to provide extensive justification up front as to its potential to meet enrollment expectations. For those sites who require external sources to meet their enrollment commitment, the sponsor’s recruitment investment should support external advertising and promotional tactics. For those sites that will rely on internal patient databases and internal referrals, the sponsor’s recruitment investment should support database mining activities, EMR surveillance support and patient communications activities. For us, 96% of the patients we put in clinical trials are from our database, so a central advertising campaign isn’t going to work. We still have recruitment expenses though. Customizing recruitment/advertising investment to match the sites’ true needs and patient-capture strategies will significantly improve the sponsor’s return-on-investment.
This article was reprinted from Volume 20, Issue 19, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »