SEARCH

SEARCH BY CITATION

The precursor to the Clinical and Translational Science Award (CTSA), the General Clinical Research Center (GCRC) program was authorized by Congress in 1959 and at its peak, more than 90 centers were funded with eight distinct pediatric GCRCs. Most of the noncategorical GCRCs were dominated by internal medicine with a very heavy utilization by endocrinology and metabolism studies from which outstanding contributions to the understanding of cancer, cardiovascular disease, respiratory disease, diabetes, endocrine disorders, and metabolism were a byproduct. In these noncategorical GCRCs, pediatric research benefited from a small fraction of resources with modest contributions to the understanding of pediatric diseases or diseases developing in childhood with implications for health across the lifespan. Most of these noncategorical centers had departments of pediatrics that were small. At sites with categorical pediatric GCRCs, the landscape was considerably different. There was robust utilization of resources for pediatric studies and considerable strides were made in understanding some of the important areas of research in infants, children, and adolescents. This environment was further catalyzed by the presence of pediatric-specific Institutional Review Boards (IRBs) that facilitated the high-quality research in pediatric populations. Although efforts were made to encourage collaborations between child health researchers across all the GCRCs, this initiative was largely ineffective.

CC-CHOC may represent the biggest benefit, to date, for the promotion of child health research within the CTSAs.

The creation of the CTSA led to increased support for clinical and translational research at 46 institutions with the promise that 60 sites will be funded by 2011. The CTSA provides infrastructure for a myriad of services not provided within the framework of the original GCRCs. GCRCs had modest support for biostatistics, study design, and biomedical informatics. The CTSAs provide a more comprehensive array of services to investigators including support for navigation of regulatory challenges; deeper and broader support for biostatistics, study design, and biomedical informatics; support for pilot projects to allow investigators to generate preliminary data for independent grant support; access to technologies to encourage transdisciplinary research; support for community-based research; and additional resources for educational and career development opportunities. With this broadening of services, has support for child health research supported by NCRR through the CTSA been enhanced? This is a complicated question to answer and it may require additional time to arrive at a conclusive answer. There is little question that the CTSA has helped to catalyze clinical/translational research and “all ships have risen” with the additional resources devoted to creation of an environment conducive to transdisciplinary research. Whether support for child health research has proportionately increased or declined with the CTSAs is an open question.

When the Request for Applications (RFA) for the CTSA was released initially in 2006, there was no emphasis placed on enfranchising child health research; however, in the subsequent RFAs in 2007 (RFA-RM-07-002) and 2008 (RFA-RM-08-002), a premium was placed on inclusion of pediatric programs within the CTSA. By including pediatrics, centers were entitled to request additional funds for their final awards. Although this appeared to be an attractive means to ensure enfranchisement of child health initiatives in the CTSA at a center, the benefit to pediatric research from the additional funds was likely unrealized. Based upon the applications, it looked like pediatrics would be recognized as “a big kid at the table,” but when CTSAs were rolled out at many institutions, it was “business as usual” with modest or no improvement in support for child health research. The more recent RFAs include no directive to include child health research. Currently, there are at least 19 dedicated children's hospitals represented with the 46 CTSAs. As prior to the CTSA program, sites that had a robust pediatric research environment benefited by the CTSA with many identifying pediatricians as either Co-PIs, as our institution at the Cincinnati Children's Hospital Medical Center and the University of Cincinnati, or as leaders of specific pediatric programs that were underwritten by substantive funding.

In an effort to determine the level of support provided to child health initiatives, leaders in the pediatric components within the CTSAs lobbied and created a CTSA Consortium Child Health Oversight Committee (CC-CHOC) whose goal was to provide collaborative opportunities designed to foster child health clinical and translational research within the CTSA program. CC-CHOC has a recognized place of importance within the CTSA Consortium with a direct report relationship to the CTSA Steering Committee placing it on a similar footing with the five Strategic Goal Committees (SGCs). CC-CHOC may represent the biggest benefit, to date, for the promotion of child health research within the CTSAs. The short-term goals of CC-CHOC are to create a multi-center IRB for pediatric studies, create metrics of success in child health research, create prioritization model for pediatric drugs and devices, create a virtual biorepository for study of rare diseases, and contribute to creation of guidelines related to core competencies for trainees in child health research. CC-CHOC has already established important relationships with the National Institute of Child Health and Development (NICHD), which led to funding of 18 Best Pharmaceuticals for Children Act (BPCA) grants and fostered interactions between multiple CTSAs. Relationships between CC-CHOC and other consortia SGCs and Key Function Committees, Pediatric Academic Societies, FDA, and NICHD will likely lead to improved support for child health research in the future. The CC-CHOC Metrics of Success subgroup is assessing the impact of the CTSAs on support for child health research, training, and pilot studies and the leadership roles that child health researchers are playing.

Independent of discipline, institutional CTSAs provide support for investigators pursuing clinical/translational research. It is currently unclear whether child health research support has gained or declined with the creation of the CTSA; however, the creation of the CC-CHOC and its initiatives may pay sizable dividends to child health research in the future. Not only does CC-CHOC “place a spotlight” on child health research, it has initiatives that will support collaboration across sites that were not realized in the past.