The ACRN – a partnership of NHLBI, eight clinical centers across the United States, and the Data Coordinating Center at Penn State College of Medicine – was initiated in 1993 with the goal of conducting well-designed clinical trials for rapid evaluation of new and existing treatments for asthma. Since 1993, ACRN has completed eight multi-center clinical trials in adult asthma with three others in progress.
As Data Coordinating Center, the Penn State College of Medicine team led by principal investigator Vernon M. Chinchilli, Ph.D., distinguished professor and interim chair of health evaluation sciences, provides expertise in biostatistical design and analysis, scientific coordination, data management, administration, and research computing for all of the ACRN's clinical trials.
"The ACRN has played a significant role in reducing the impact of asthma morbidity and mortality and we are proud to have been one of the original partnering institutions," Chinchilli said. "This significant grant allows us to continue providing expertise to our clinical partners across the country and to contribute to the evaluation of novel therapies to help the more than 20 million people in the United States who suffer from asthma."
The Data Coordinating Center team has developed a unique data management system to support the collection, verification and reporting of clinical data. Asthma patients who agree to participate in an ACRN clinical trial visit one of the clinical centers where medical staff take respiratory response measurements. In addition, patients record their symptoms, medication use and at-home respiratory measurements in personal diaries, which they share during clinic visits. The clinic personnel enter the patients' information into a password-protected portion of the ACRN Web site, which was developed by the Data Coordinating Center and configured to accept the data and conduct validity checks.
"Our Data Coordinating Center is vital to the success of the ACRN's clinical trials because it has the experience and skills for the successful design, development, implementation and analysis of multiple clinical trials simultaneously," Chinchilli said. "The incidence of asthma continues to increase and many patients are resistant to currently available therapies. Development of new and improved treatments is critical to the control of their disease and their quality of life."
For all of the ACRN's 10 years, the Penn State Hershey team has continued to evaluate and modify the data collection system to improve data quality in a cost-effective and labor-efficient manner. Their pioneering approaches have molded the ACRN into a world leader in asthma clinical research.
In addition to collaborating on more than 25 of the ACRN's scientific publications, the Data Coordinating Center was instrumental in producing a compilation of 11 peer-reviewed articles that appeared in a special supplement to the scientific journal, Controlled Clinical Trials, on ACRN activities related to its organizational structure, clinical trials, data management processes, randomization schemes, quality control methods, and recruitment and retention issues. The methodologies developed by the Data Coordinating Center faculty and staff provide lessons and standards applicable to multicenter clinical trials across disciplines.
In addition, Chinchilli has directed the dissertation research of three Penn State doctoral students whose work has focused on developing new biostatistical methods for the ACRN's innovative clinical trial designs.
"We will continue to innovate and bring the latest technologies for the design and conduct of clinical trials to the ACRN so that we and our clinical investigators will find new ways to help those with asthma," Chinchilli said.
The ACRN clinical centers are: Harvard University, Brigham and Women's Hospital, Boston; National Jewish Medical and Research Center, Denver; University of California, San Francisco Medical Center; University of Wisconsin, Madison; University of Pittsburgh Medical Center; Wake Forest University Baptist Medical Center, Winston-Salem, N.C.; University of California, San Diego Medical Center; Washington University, St. Louis.