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    Expert's Opinion

    Pushing Research to Its Full Potential

    How novel innovations can preserve the physician-patient relationship

    Pushing Research to Its Full Potential
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    Rebecca Kush, CSO, Elligo Health Research04.26.19
    A critical gap between clinical research and health care diminishes opportunities for patients to access state-of-the-art therapies. Concurrently, research studies today are routinely delayed because they fail to enroll enough patients. Major academic health centers typically conduct clinical research, while most patients are treated in community practices. This means that patients who wish to participate in research studies to access the latest treatment options may not only have to travel long distances to the nearest academic institution, but they must also transfer into the care of a new physician. 
     
    The logical resolution to this concern is to better involve physicians in these community practices. However, community physicians with an interest in research are handicapped in that they do not have the time, incentives, or administrative support to conduct clinical trials. In addition, they typically are not aware of such opportunities and do not have the bandwidth to find them and engage. The failure to engage community physicians is a major reason why the industry is failing to engage patients: Only about 3% of eligible patients participate in research, leaving the other 97% lost to clinical research opportunities.
     
    As a result of this low patient and physician participation in research, development of new therapies is slower, and there is a lesser opportunity for research findings to inform health care decisions that can benefit future patients. This gap between clinical research and health care is significant and diminishes opportunities for patients to access state-of-the-art therapies.
     
    In a January 2019 Scientific American article, author David Freedman explores why most patients with cancer are not involved in clinical research.1 He describes well the fact that most of these patients are in community practices where physicians are unaware of research opportunities, and he elaborates on the benefits to a patient who was offered such an opportunity albeit at an undue burden incurred by her physician who spent his off duty time to do this research. Freedman proposes a combination of opportunities that could effect change, including study designs that could reduce physician workload, study sponsors building awareness of research opportunities in community practices, and automating patient-trial matching. 
     
    Clinical research service organizations can begin to narrow the gap between research and health care by uniting best known practices with novel technology and infrastructure to engage patients and community physicians. By enabling physicians to prioritize patient needs while reducing their own administrative burden, the trusted physician-patient relationship can be retained to provide the best care options for patients while keeping both the physicians and patients engaged in the research.  
     
    Reducing the burden on physicians is feasible through the implementation of innovative technologies and certain recommendations encouraged by regulators. These recommendations come from recent guidance and supported through the 21st Century Cures Act.
     
    Leveraging electronic health records to identify patients is being done now in large academic centers, but new methodologies are essential for this to be feasible at community practices. Perhaps most importantly, when such methodologies are combined synergistically with infrastructure support and new tools that collect data in global standard formats from the source, the result can be a cohesive system to accelerate research. This system can provide management information in real-time for robust governance and patient safety and improve data quality and integrity while reducing resource requirements and costs. Such a system is transformative in that it enables and incentivizes community physicians to conduct research with their own patients, while experiencing far less risk and more reward.
     
    When physicians can be made aware of research studies that are matched to their patients and can also be provided with the necessary infrastructure and technologies to do these studies, clinical research can be advanced to its fullest potential. Only in these ways will the industry be able to close the gap between health care and research for the benefit of more patients everywhere.
     
    Rebecca Kush, Ph.D., is the chief scientific officer for Elligo Health Research. She founded the Clinical Data Interchange Standards Consortium (CDISC) where she spent 20 years leading the development of global clinical research data standards to streamline clinical research. While there, she served as the president and CEO and had an integral role in the development of methods and processes to link research and health care. Throughout her career, Kush has also worked for the U.S. National Institutes of Health, academia, a global contract research organization and both U.S. and Japanese pharmaceutical companies. She has a doctorate in physiology and pharmacology from the University of California, San Diego, School of Medicine.


    1. Freedman DH. Clinical Trials Have the Best Medicine but Do Not Enroll the Patients Who Need It. Scientific American. January 2019. https://www.scientificamerican.com/article/clinical-trials-have-the-best-medicine-but-do-not-enroll-the-patients-who-need-it/. Accessed April 4, 2019.
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