Tulane researcher helps diabetes trial attain record participation

A 99.7 percent patient follow-up rate was applauded at an American Diabetes Association meeting.
A 99.7 percent patient follow-up rate was applauded at an American Diabetes Association meeting. | File photo

Tulane University Clinical Translational Unit Director of Clinical Research Roberta McDuffie recently served as the national study coordinator for the Liraglutide Effect and Action in Diabetes–Evaluation of Cardiovascular Outcome Results trial that spanned five years and involved 9,340 patients.

McDuffie  coordinated 118 domestic sites and served on the International Panel for Recruitment and Retention for the remaining 292 sites spread over 32 countries. 

While the study results showing that the drug reduces cardiovascular events in high-risk type 2 diabetes patients by 13 percent were exciting, the behind-the-scenes figure of a 99.7 percent patient follow-up rate also sparked significant buzz when the trial was presented at an American Diabetes Association meeting in New Orleans.

“This is a new record for the smallest number of loss-to-follow-up ratio for a cardiovascular outcomes trial of this size. It’s particularly notable because the [U.S. Food and Drug Administration] puts such a value on this for the validity of your data in the study results,” McDuffie said. “When they announced that retention rate, people were amazed. People stood up and were clapping.”

In addition to McDuffie’s role in the trial, Tulane also served as one of its largest sites, with approximately 60 participants.