Montana Pediatric Clinical Trials Site

总结

Summary Montana and neighboring Institutional Development Award (IDeA) states include a high proportion of vulnerable pediatric populations, but these populations have limited to no opportunities for inclusion in multi- site clinical trials. The IDeA States Pediatric Clinical Trials Network (ISPCTN) is being created to provide access for underserved and rural populations to state-of-the-art clinical trials and to transfer findings that will benefit the health of all children. The focus of ISPCTN trials will be varied but priority will be given to the four focus areas of the Environmental influences on Child Health Outcomes (ECHO) Program which include: 1) upper and lower airway disease; 2) obesity; 3) pre-, peri-, and postnatal outcomes; and 4) neurodevelopment. Through this cooperative agreement the Montana Pediatric Clinical Trials Site (MPCTS) will be a partner member of the ISPCTN. In coordination with the ISPCTN Data Coordinating and Operations Center (DCOC), MPCTS will be a participating recruitment location for ISPCTN Steering Committee-approved multi-site clinical trials. To accomplish this goal the Missoula, Montana based MPCTS team will be led by a board-certified pediatric scientist-investigator and supported by a pediatric-trained Research Nurse Coordinator, a Data Manager and database support. MPCTS will also utilize a part-time nurse at each of two collaborating healthcare centers in Billings, MT and Kalispell, MT. As with the primary Missoula healthcare center, these partner healthcare centers are the specialty and subspecialty pediatric care providers for their respective regions. Collectively these locations serve as the main referral sites for pediatric specialty care in Montana as well as communities in the neighboring IDeA states of Wyoming and Idaho. MCPTS will enhance pediatric recruitment capabilities at these and other sites by leveraging existing IDeA programs in Montana, Wyoming and Idaho to engage health providers and reach out to vulnerable communities. Beginning in year two of this cooperative agreement MCPTS will participate in one or more multi-site pediatric clinical trial(s). Our evaluation plan will be conducted on a continuous basis to assess program effectiveness and to identify opportunities for continuous quality improvement to ensure that the MCPTS meets the needs of our regional pediatric populations by facilitating improved access to cutting-edge pediatric clinical research.