A research center at the Yale School of Public Health has been refunded with a $16.5 million grant to continue its support for a clinical research network whose discoveries could help millions of couples struggling with infertility.
The refunded center, the Data Coordinating Center, is part of the Reproductive Medicine Network (RMN), which also includes six other universities. Scientists from the network recently found that the drug letrozole is more effective than clomiphene citrate, the first line infertility drug for women with polycystic ovary syndrome or PCOS.
Heping Zhang, principal investigator of the Data Coordinating Center at the Yale Collaborative Center for Statistics in Science, or C2S2, is the senior author of the study published this month in The New England Journal of Medicine. The grant is from The Eunice Kennedy Shriver National Institute of Child Health & Human Development.
“This study will change how doctors treat their infertile patients with PCOS,” said Zhang, the Susan Dwight Bliss Professor of Biostatistics at Yale School of Public Health and professor at the Yale Child Study Center and the Department of Statistics. “The study is a great success for multidisciplinary collaboration and team work.”
Zhang and his colleagues also concluded that the two drugs have similar safety profiles, and that the number of birth defects are comparable between the two treatments. Women taking letrozole, however, were more likely to experience dizziness and fatigue, whereas women taking clomiphene citrate experienced more hot flashes.
The finding has the potential to affect infertility treatment in the United States and beyond, Zhang said. Letrozole has been used to treat infertility since 2001. This is the first clinical trial that was powerful enough to evaluate letrozole against another widely used medication for infertile women with PCOS. Letrozole is also used to treat several other medical conditions, including local or metastatic breast cancer, endometriosis and gynecomastia.
“I can’t emphasize enough how important a nimble data coordinator center is in accomplishing timely clinical trial recruitment and presentation of findings,” said Dr. Nanette Santoro, chair of the RMN steering committee. “The Yale Data Coordinating Center, under Dr. Zhang's leadership, has been an outstanding partner for the clinical sites and has helped the Network have its most productive funding cycle by far over the past 5 years.”
Dr. Richard Legro, the lead author of the article, said that Zhang and his team “bring a remarkable attention to detail and a rapid response to problems at all phases of a clinical trial from planning to start up to recruitment to close out and to publication of results.”
Zhang created and has directed C2S2 since 2005. The center now has about a dozen scientists, including full-time research staff, visiting scholars and pre- and postdoctoral students. This $16.5 million grant will allow it to carry on a major part of its work for the next five years. The center specializes in developing statistical methods and technologies that address disease origins and health-related issues such as infertility, as well as genetic and environmental factors associated with complex disorders, particularly substance use.
C2S2 is a partnerin RMN with six other research sites as well as their satellite sites around the United States. It also serves a similar role in the Genomic and Proteomic Network for Preterm Birth Research that was established in 2005. This group concentrates on the most common form of preterm birth that is associated with the highest mortality and morbidity rates for infants. It uses genomic and molecular research strategies to analyze and disseminate data.
Zhang said that over the next five years, he wants his center to maintain its unique strength in both methodological developments and translational clinical trials. Besides his leadership in the NIH-funded studies, Zhang has led the establishments of multiple clinical research consortia and a statistical research center in China.
One of his major efforts there is to evaluate the effectiveness of Chinese medical approaches such as acupuncture for infertility treatment. While Chinese medicine has been practiced for thousands of years, scientifically evaluating its effectiveness has been a challenge. Zhang believes this can be overcome by training the next generation of scientists and experts in China and by establishing scientific and ethical standards for clinical research.