Improving clinical trials: 2013 workshop findings
“Significant opportunities exist to accelerate the use of LSTs [Large Simple Trials] to efficiently generate practical evidence for medical decision making and product development. Data for LSTs can be obtained from electronic health records (EHRs), whose increased adoption continues to be driven by the implementation of the Health Information Technology for Economic and Clinical Health Act, which pays incentives to hospitals or eligible office-based professionals if they demonstrate use of their EHRs in a meaningful way. With more than 40 percent of hospitals and office-based physicians employing at least a basic EHR system in 2012, the ability to collect research data in the course of regular care is greater than ever (RWJF, 2013). This could allow trials with streamlined data collection requirements to be supported by data captured in preexisting EHRs. For example, the Study of Technology to Accelerate Research (STAR) in Massachusetts (which is discussed in more detail in Chapter 3) successfully based its ongoing trial on childhood obesity screening and management strategies on the electronic medical records already in use at each of its 14 participating sites (Clinicaltrials.gov, 2012). STAR offers a strong example of how the EHR can be used as the foundation for LST design and implementation.
With the potential for such applicability and widespread use, LSTs present the opportunity, together with and as a complement to quasiexperimental methods, registries, and safety efforts, to improve the speed and practicality of knowledge generation, characteristics fundamental to a learning health care system. With the development of new technologies capable of acquiring, managing, linking, and analyzing large quantities of data, the potential for innovation in methods, including the ability to draw research insights from routine clinical care experiences more effectively, is growing. Moreover, the increased use of innovative methodologies, such as LSTs, and their incorporation into routine clinical care can allow more patients than ever to engage in research to improve health care delivery and outcomes. Through streamlined protocols, the electronic availability of trial tools and outcomes data, and capabilities for remote participation, every patient has the potential to be a contributor to the continuous learning process and improve not only the outcomes of treatment for that individual but also the outcomes for other patients with similar conditions. LSTs offer the potential to drive the transformation necessary to realize this vision.”
Click here to read more from this National Academies Summer 2013 workshop summary (released in December 2013).