Years ago sponsors generally believed that site enrollment support simply involved developing generic outreach materials, mailing them out to each site and perhaps holding a brief training session on how to use the materials. It’s no wonder most studies failed to enroll on time. Today, most patient enrollment specialists, including BBK, define site enrollment support in terms of five broad areas of action.
1. Building a Community
Establishing a community is all about study relations, those activities on behalf of the sponsor that help everyone involved in the study build relationships with one another. This means patient enrollment specialists must be skilled in multitasking. They act as a manager, communicator, interpreter, and consultant on behalf of the sponsor but with the simultaneous responsibility for representing members of the study community and the patients.
Site enrollment support involves building trust among players with widely different agendas, all functioning within one common recruitment-focused environment. It is the patient recruitment specialist’s job to put systems in place. These systems can include establishing new channels for communication, methods for reporting, and conducting training sessions for study staff. Over time, these small achievable tasks help to build trust between all players in the study community.
Yes, training still involves demonstrating the outreach tools and materials for site support, and educating site staff on how to use them. But it also can include guidance on IRB / EC submissions or advising each site on how to approach data mining of existing patient records. Training might cover scheduling planning so sites can understand how they can continue to move forward with patient recruitment activities while awaiting IRB / EC responses. And it can also extend to specialized training to address issues that appear at some or all sites as the study unfolds.
3. Intelligence Gathering
Patient enrollment specialists represent the sponsor and operate in the best interest of the study. They are an ideal source of information, both quantitative and qualitative. As someone who is working with the sites, the patient enrollment specialist is the ideal person to identify best practices early in the study and help spread them to other sites.
4. Patient Recruitment
A patient enrollment specialist provides a full-time focus on patient recruitment. Someone who will monitor enrollment progress at every site, identify similar challenges and provide recommendations and resources to strengthen recruitment efforts wherever needed. This might be as simple as arranging a conference call among sites with common issues, or traveling to a site to resolve a specific local recruitment issue.
5. Keeping Study Top of Mind
The importance of keeping a sponsor’s study top of mind at each site is its own challenge. With research coordinators handling multiple studies, and with sites often juggling multiple competing studies, it’s the patient enrollment specialist who makes sure each study gets its rightful share of attention.
BBK has accumulated evidence that this kind of study support actually increases the likelihood of a study enrolling on time. When communication programs support the study community, all audiences operate in a responsive environment that promotes flexibility and enhances interactions between patients and the clinical staff.