The PFDN Team is comprised of representatives from the sponsor, the Eunice Kennedy Shriver National Institute of Child Health and Human Development; from seven clinical centers; and from one data coordinating center, RTI International.
Clinical Centers
The clinical centers participating in the cooperative agreement with NICHD represent academic institutions with experience in multi-center clinical research in pelvic floor disorders. They have agreed to abide by the study protocols and have comparable staff, facilities, and equipment.
The leadership at each clinical center is provided by the Principal Investigator (PI), who assumes responsibility for all aspects of the center's participation in the Network and participates (with the NICHD and Data Coordinating Center) as a member of the Steering Committee. Each Principal Investigator is a practicing physician with substantial experience in caring for female pelvic floor disorders.
The Research Nurse Coordinator oversees the conduct of the Network clinical trials. Under the supervision of the PI, the Coordinator is responsible for the conduct of Network protocols, including adherence to protocols, collection of data, supervision of data transmission, data quality, and staff training.
Data Coordinating Center (DCC)
The primary objective of the Data Coordinating Center, RTI International, is to provide data management and biostatistical support and consultation in the areas of design, execution, and analysis for the Network studies. The DCC provides substantial logistical support for these studies and also assists in development of the study materials, including the protocols, study manuals and forms.
NICHD Staff
The NICHD Pelvic Floor Disorders Network (PFDN) is funded through the Gynecologic Health and Disease Branch (GHDB). Because the GHDB recognizes that research on some gynecologic topics is still underfunded (for example, pelvic floor disorders affect almost one-quarter of women between ages 20-80 according to the National Health and Nutrition Examination Survey and as many as 10 percent of women in the United States will undergo a major surgical procedure to correct urinary incontinence or pelvic prolapse), it supports research on pelvic floor disorders which affect the reproductive system and other pelvic organs. These disorders include pelvic prolapse, urinary and fecal incontinence, and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tract. The NICHD PFDN Project Scientist provides substantial scientific support as a participant in the scientific efforts of the Network, as well as in review and oversight of the efforts of the Network. Additional information on the activities of GHDB can be found at https://www.nichd.nih.gov/about/org/der/branches/ghdb.
Steering Committee
The PFDN Steering Committee has primary responsibility for the development and conduct of protocols and the preparation of publications. The Steering Committee membership is limited to the Principal Investigator from each Clinical Center, the Principal Investigator from the Data Coordinating Center, and the NICHD Program Scientist. An outside Steering Committee Chairman, who is not participating as a principal investigator is appointed by the NICHD.
Members of the Steering Committee are:
- Katherine E. Hartmann, MD, PhD, Vanderbilt University, Steering Committee Chair
- Donna Mazloomdoost, MD, NICHD Program Scientist
- Vivian Sung, MD, Brown/Women and Infants Hospital of Rhode Island PI
- Kimberly Kenton, MD, University of Chicago PI
- Emily Lukacz, MD, University of California at San Diego PI
- David Rahn, MD, University of Texas Southwestern PI
- Nazema Siddiqui, MD, Duke University PI
- Heidi Harvie, MD, University of Pennsylvania PI
- Marie Gantz, PhD, RTI International, DCC PI