Alexandria, VA The Patient Protection and Affordable Care Act of 2010 mandates a national comparative outcomes research project agenda for pragmatic and clinical trials that provide optimal evidence-based medicine, according to an article published in the October 2011 issue of Otolaryngology Head and Neck Surgery.
The Tufts Center for the Study of Drug Development recently reported that the median number of procedures per clinical trial increased by 49% between 2000-2003 and 2004-2007, and the total cost grew by 54%. Overall, growth in complexity and execution burden grew at the slowest rate for protocols in phase III, as companies, looking to contain costs, gathered more data in early phases. The therapeutic areas with the highest number of phase I procedures from 2002 to 2007 were anti-infectives, immunology, central nervous system, oncology and cardiovascular.
"Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients,'' according to the Center for Evidence-Based Medicine.
The Patient Protection and Affordable Care Act of 2010 provides for insurance ''exchanges,'' accountable-care organizations, patient-centered outcomes research, physician quality reporting initiative, and electronic health records. The mission of the Patient-Centered Outcomes Research Institute is to identify, and carry out, a national comparative outcomes research project agenda.
The results of the study show patient-centered outcomes research, physician quality reporting initiative, and EHRs will create exponential growth of observational data in the electronic data warehouse. High-quality associations will identify research topics for pragmatic clinical trials, and systematic reviews of clinical trials will provide optimal evidence-based medicine.
"Health care reform will provide a robust environment for comparative effectiveness research, sys
|Contact: Mary Stewart|
American Academy of Otolaryngology - Head and Neck Surgery