CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Mary Schmoll, director of clinical research at the American Health Network of Indiana (AHNI), which offers clinical research at seven investigative sites in Indiana. AHNI’s Research Department won the Society for Clinical Research Sites’ 2016 Site Patient Recruitment Innovation Award (SPRIA), which recognizes research sites that have developed and implemented innovative patient recruitment programs.
Q: AHNI was named the SPRIA winner for its clinical trial alert (CTA) system, which leverages the health network’s EMR to identify potential study participants. What issues did you want to address in developing the CTA system?
A: We have a robust EMR database, but we had been conducting database searches using built-in search engines, which were very cumbersome to navigate. It was difficult to search across numerous parameters and query the data. For instance, we had to export data to Excel spreadsheets and try to cross-reference multiple spreadsheets across various trials to delete duplicates, patients who asked not to be contacted further for clinical trials and those already participating. It was a very labor-intensive process.
Our CTA system, which works alongside our EMR to assist us in identifying and evaluating potential research candidates, is extremely user-friendly. The system runs in the background of our EMR system and continually scours the database looking for patients who meet the key inclusion/exclusion criteria that we enter. It allows us, on an ongoing basis, to query the database. Patients who meet the criteria are automatically sent to a candidate list for further evaluation.
The CTA system, which was developed by Simbiote Development, also allows us to run preliminary searches of our entire database prior to opening study enrollment. We can quickly evaluate thousands of candidates, funneling those who meet the key inclusion/exclusion criteria into a candidate list for further evaluations by our centralized recruitment staff. For a diabetes study conducted at five of our sites, we ran a preliminary search of some 800,000 patient charts, which yielded 1,800 potential candidates in less than 30 minutes. The recruiters reviewed each candidate for potential participation in the trial so that prior to site initiation visits, we had a complete pre-screened candidate list for each site. Once the site received the okay to begin recruitment, we could reach out to pre-screened patients right away to offer trial participation and bring them in for screening. For the diabetes trial, within a period of just a few months, we scheduled 92 screenings, screened 62 candidates and randomized 32 candidates. Leveraging the data within our EMR using an automated system allowed us to save valuable staff resources and, in an efficient manner, review thousands of potential candidates across the state.
Q: Is the education and involvement of network physicians an important component of your department’s patient recruitment efforts?
A: With limited physician awareness about enrolling trials, confusing and often difficult to remember inclusion/exclusion criteria, difficulty in following the referral processes and a lack of available time, we find providers tend to place research in the background.
Our CTA system allows us to place research back at the forefront without any additional burden on our providers. The system allows us to alert providers, in real time, when patients who meet key inclusion/exclusion criteria for a particular trial are in the office for a regularly scheduled visit. Providers receive a pop-up message on their computer screen with details of the trial. By providing customizable trial-related information when a patient is in the office, our providers can easily discuss trial participation with potential study volunteers face-to-face. If the patient is interested in the trial, with a click of a button on the screen, the provider can send the patient record to recruiters for a more thorough prescreening.
Recruitment and retention of trial subjects has forever been a major headache for sponsors and sites alike, leading to tremendous expense and sometimes lengthy delays in bringing new therapies to market. Studies show that only a very small percentage of patients who qualify for clinical trials ever participate. By involving our providers to get the word out, we can increase outreach to potential trial participants. Additionally, studies show that when providers talk to their patients about trials or encourage them to participate, they are much more likely to volunteer.
We work across numerous sites, so we use many different methods to spread the word about trials to our providers. We also have regular staff meetings, send out emails and post flyers.
Q: What are the biggest overall challenges you encounter in patient recruitment and how can they be addressed?
A: From a global perspective, the largest recruitment challenge is public awareness. The knowledge and attitudes of potential participants can often hinder enrollment. We need to get the word out about the benefits of clinical trials and dispel the myths. Pharmaceutical companies, CROs and organizations need to be more proactive in reaching out to the public and educating them about research, the research process and how it impacts the development of future therapies.
This article was reprinted from Volume 21, Issue 01, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »