CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Blake Liebeskind, president of Sunrise Medical Research in Florida, 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 your innovative approach toward enrolling for an influenza study that used study participants to help recruit exposed family and coworkers.
A: Every year, as flu season approaches, sponsors are anxious to get as many positive subjects into enrolling influenza protocols as possible. Flu studies can be particularly challenging because subjects are required to enroll within 48 hours of the onset of symptoms. In addition, they must be willing to visit the clinic on an average of five days within the first week of enrollment and there are a lot of diary requirements.
When you are sick with the flu, it’s an inconvenience to do anything. You feel too sick. There is no motivation for these patients to participate.
After working with the sponsor and IRB, we were able to increase the stipend substantially from $40 to $100 per visit, plus an additional $10 per diary entry. Most people with the flu miss an average of five days of work, in most cases without pay. The increased patient stipend helped to offset the loss of income for many participants and we greatly improved our introduction to consent rate to more than 90%.
However, identifying subjects within 48 hours of symptom onset was still our biggest challenge. We decided to follow the source of the flu instead of waiting for the patient, who might or might not qualify for the study, to show up at our site. As soon as we enrolled a positive subject, we asked a series of questions: Who else do you know that is sick? Anyone in your family? Any coworkers?
We gave a “recruitment bag” to each subject filled with IRB-approved study flyers, tissues with our site’s telephone number and a few cards with direct contact information for the study coordinators. Patients recruited family and coworkers with enthusiasm. Our best result came from a school teacher who tested positive for flu. We asked if she had any coworkers who were sick. She called a couple and hung an IRB-approved study flyer in the teacher’s lounge. We had four people from that school enter the study.
On average, every patient who came into the practice would refer two-to-three other patients. This recruitment idea enabled our site to exceed our contracted enrollment goal and made our site the top enroller. The total cost for recruitment materials was $757.37 to enroll 94 patients. During a previous flu season, it cost $9,500 in advertising costs to enroll 38 patients.
Q: Patient recruitment and enrollment remains one of the biggest challenges in clinical research. From a site perspective, how do you think this issue should be addressed?
A: Recruitment starts with asking what the patient needs. What is the motivation and benefit for the patient participating in the study? Often sponsors and CROs think the patient needs their new drug or device, but it’s truly the other way around. We need the patient more than they need us at this stage of developing new drugs. Too often protocols are designed with patient diaries that are too complicated and the patient reimbursement isn’t attractive enough to entice compliance from a patient’s perspective. Their time is money, too.
Secondly, clinical trials education needs to be addressed. Nine out of 10 people who walk into the clinic don’t know anything about clinical studies. Nobody wants to be a guinea pig. We need to explain what clinical studies really are to patients.
Q: Are there specific ways that CROs and sponsor companies could better support sites?
A: From our perspective, an area that needs to be addressed is budgets. We have the patients. But often budgets are not worth the time or effort to pursue. During 17 years of being in the industry and conducting hundreds studies, I have seen very little meaningful increase in budgets. But there has been an increasing workload on the sites. There is more regulatory work, more people to be accountable to and more portals for payment and training. Along with poor payment terms, there has been more uncertainty as some studies are opened and then closed without any warning. If the sponsors or the CROs are not supporting the sites properly, they are not going to get the results they need.
Sometimes there seems to be a real disconnect between the sponsors, CROs and sites. When a site feels they are in true partnership with the sponsors and CROs, they will go the extra mile. When there is good communication and good budgets in place, those studies run smoothly and enrollment goals are met or exceeded easily.
What made our flu study successful was having a close relationship with the sponsor. It’s difficult when you have so many people to get through to get to the decision-makers. But we were able to work with a decision-maker able to understand exactly what we were trying to accomplish. Our most successful studies are those where we work directly with the sponsor company.
This article was reprinted from Volume 20, Issue 29, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »