Clinical Research Informatics: Enabling “Real” Change in the Healthcare System?
When the recent change in presidential administration is coupled with the multitude of explicit and implicit promises over the past year of intense political campaigning to “fix” the U.S. healthcare system, it seems likely that significant change will occur within our healthcare research and delivery community over the next several years. Given such a likely turn of events, the question must be asked, what is the role of Clinical Research Informatics (CRI) in such transformative change? Superficially, raising such a question could be perceived as getting on the healthcare reform “bandwagon”, but I would argue that instead, CRI is truly positioned (and has been for a number of years) to serve as a catalyst for real and meaningful improvements to the healthcare system.
At the highest level, it has been, and continues to be argued that to “fix” our healthcare system (and the massive fiscal price tag of that system, which could reach over 18% of our GDP by 2013), we must:
Of the preceding four, high-level factors, three (75%), are anchored at least in part upon the ability to leverage the best available evidence to support high quality, safe, and cost effective care. What’s more, much of the evidence needed in such a modernized healthcare delivery model, is novel, since the required knowledge would focus upon predictive and preventative methods of health management (e.g., personalized healthcare) as well as the workflow and business models needed to enable such care (e.g., operations and outcomes research). Clinical research is the engine by which such evidence and knowledge is generated, and the modern conduct of clinical research in almost all cases requires the application of CRI theories, methods, and technologies in order to manage the predominantly high-throughput, multi-dimensional data being collected, integrated, analyzed, and disseminated by sucn endeavors. Therefore, current discussions focusing on the need to ensure wide-spread adoption of EHR technologies as a panacea for addressing what currently ails our healthcare system are in fact only addressing part of the problem at hand. The adoption of EHR technologies will undoubtedly address fundamental issues such as consistent access to care across providers; the provision of evidence based decision support; and improved safety due to automated medical error detection and prevention. However, if such technologies are not designed, implemented and managed in such a way that they can also support the full spectrum of clinical research and by extension CRI activities, we will have lost one of the greatest opportunities available to us to truly reform the healthcare delivery system.
Simply put, EHR technologies in the absence of closely integrated CRI platforms will yield an empty promise in terms of realizing transformative change, since such change must be predicated on both technology and the evidence-based knowledge of how to optimally employ that technology – knowledge generated by clinical research.