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October 6, 2009

CCTS and Clinical Directors Network Successfully Complete First Collaborative Project
By Angela Slattery

In the fall of 2008, through the Advisory Committee on Community Engagement and Recruitment (ACCER), Clinical Scholar Dr. Andreas Mauer was introduced to Dr. Jonathan Tobin, President and CEO of the Clinical Directors Network (CDN). CDN is a not-for-profit network that supports community-based health centers, including their patients, practitioners, and other affiliated organizations. Community health centers work with CDN to assist with projects and facilitate community engagement.

Dr. Mauer and his mentor, Dr. Barry Coller, were interested in developing and validating a Web-based bleeding history phenotyping system. The goal of this initial project was to validate the instrument. The eventual goal is to provide the system to all authorized investigators with Internet access so that they can have the opportunity to collect bleeding history data in a standardized way and store the information in a single, uniform database. This database would aggregate deindentified data obtained by many different investigators and would be freely accessible to investigators worldwide. Potential applications of the system include: 1) improving diagnosis of bleeding disorders, 2) identifing the fewest number of questions needed to exclude the presence of a significant bleeding disorder with high probability, 3) identifing patients whose laboratory data and bleeding symptoms are discordant for future gene-gene and gene environment studies, and 4) assessing the medically optimal and most cost-effective way of deciding whether to order an extensive laboratory evaluation.
Dr. Mauer obtained approval to enroll 500 normal healthy participants in this study from the Institutional Review Board (IRB) and Advisory Committee for Clinical and Translational Science (ACCTS). CDN was an ideal partner for this project because it could assist in recruiting participants from community settings and their participation would broaden the diversity of the population studied. Drs. Coller and Mauer visited the Jersey City site together, met with the staff, and learned from them about the bleeding (hemostasis) problems they face in their practice. Dr. Coller provided a lecture on hemostasis for primary care physicians and described the goals of the project. Ultimately, from the 500 total participants in the study, 365 were seen at Rockefeller University Hospital, 75 were seen at Metropolitan Health Center in Jersey City, NJ and 60 were seen at Newark Community Health Center in Newark, NJ. Dr. Mauer oversaw the project and Dr. Chamanara Khalida from CDN played an important role in recruiting and interviewing patients, as well as educating the staff at the sites about the project. The time from study approval to study completion was approximately 10 months; the Clinical Research Support Office (CRSO) recruitment program, with the outstanding assistance of the CDN staff, made this accomplishment possible.

In addition to CDN’s role in assisting with participant recruitment, the project benefited enormously from Dr. Tobin’s expertise in study design and statistical approaches. Data from the study were presented by Dr. Mauer in July 2009 at the International Society on Thrombosis and Hemostasis meeting in Boston. Dr. Tobin, Dr. Mauer, and Dr. Coller are working together on future collaborations. Dr. Mauer stated that, “Dr. Tobin has been extremely helpful with so many aspects of this project. I look forward to future collaborations with Dr. Tobin and CDN.”

If you would like to contact Dr. Tobin to discuss whether your project may benefit from collaborating with CDN, you can contact him at JNTobin@CDNetwork.org or call 212-382-0699 ext. 234.