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Experience with a Technology Solution for Early Phase Clinical Research: Focus on Volunteer Registration and Trial Recruitment

Julie A. Eckstrand1, R.Ph, BS Pharm, Matthew Gardner2, Stephen K. Woody3


Director Clinical Support Services and Quality Management, Duke Clinical Research Unit, 2IT Consultant, Duke Clinical Research Institute, 3Associate CIO, Duke Translational Medicine Institute

In February of 2010, the Duke Clinical Research Unit (DCRU) began collaboratively building an early phase software solution with the goal of creating an authoritative source document for early phase research that fully represented clinical variables via deconstructed work-flow , with innovative options , and data capture via device interfaces. It is being built in modular releases including volunteer management, biospecimen tracking, resource management and electronic data acquisition. The most urgent business identified need was volunteer intake. In March of 2012, a web application that supports volunteer recruitment work-flow for clinical trials was launched. Core functionality includes: Study setup (interface with eIRB) Contact Activity tracking Capture of pre-screening questionnaire responses (eResearch interface) Study interest and prescreen pass/fail rates Secure storage and access to consented volunteer profiles (Master Patient Index interface) Screening appointment scheduling/Automated emails including Appointment reminders

One of the most difficult aspects of conducting clinical research is overcoming the challenges in participant recruitment. Compressed timeframes and limited budgets of early phase trials in particular, dictate the need for fast enrollment of complete cohorts and cost effective recruiting. In order to achieve our broader scorecard goals of increasing enrollment in NIH funded interventional trials for the Duke Health System by 20% annually, and increasing satisfaction scores for our research participants demonstrated by survey results, we will need to be efficient and we will need to engage in an ongoing relationship with our potential participants. The DCRU created a research participant recruitment core in 2011. Plans are now in place to expand this core as a common resource available to all investigators at Duke. Our multi-faceted approach to recruitment will include: Evaluating enrollment feasibility Establishing realistic enrollment targets Developing study-specific recruitment plans and campaigns Management of recruitment The technology solution for the recruitment core is the Volunteer Management System used by a centralized call center.

2,983 Consented Registrants 23 Studies: 7 complete, 16 ongoing 18 Disease-Based, 5 Healthy Volunteer 15,500+ Contact Activities 48% incoming, 52% outgoing, , 27% of contacts resulting in pre-screening. Cost Per Touch Analysis:

Next Steps Web Registration- Go-Live March/Apr 2013

An Enterprise-Wide and Global POC Unit Solution

Actively Recruiting Studies at Duke

Robert Califf, MD Vice Chancellor for Research Duke University John S. Sundy, MD, PhD Global Director, Duke Proof of Concept Network and Faculty Director of Phase 1 Trials DCRU Recruitment TeamSabrena Mervin-Blake Elise Pangborn Nick Eberlein

Leveraging Social Media

The DCRU recruitment core staff evaluate enrollment feasibility, establishing realistic enrollment targets, develop and adjust study-specific recruitment plans and campaigns and manage overall recruitment for each trial they provide services for. The volunteer management system makes this possible. Next steps also include expanding the use of this application as a solution in our Global Network of early phase units.

Velos TeamDr. Amar P.S. Chahal John S. McIlwain Rohit Agarwal Sarbjot Grewal Nick Bobrinskoy The authors of this presentation have nothing to disclose.

Participant Contact History: The benefits we have gained by using this technology include the ability to: Efficiently manage an ethnically and racially diverse pool of potential research candidates Track and quantify the success of recruitment campaigns Aggregate uniform data (codified) Leverage data driven methodologies to quantify effort and cost required to successfully enroll participants Geographic Distribution: Modify recruitment plans in an expeditious and agile way- via document management, compliance rules Eliminate duplicate volunteers Eliminate communication collisions View the entire contact history by volunteer Communicate regularly with participants (low no-show rates, relationship building) Scale recruitment services to the enterprise level From the recruiters: One of the greatest benefits of the software are the automated emails to scheduled participants with consent, directions, date/time of appointment all in one message, and the ability to send appointment reminders, The comment field in the contact activity lines make it easier for multiple recruiters to handle a single subject, now that we have this software, I dont know how I would get through the day without it

To date, we have managed close to 3000 volunteers as well as more than 15,500 contact activities and recruited for 23 trials.

Julie Eckstrand Assistant Director, DCRU DUMC Box 3854 200 Trent Dr. Durham, NC 27710 (919) 684-1670