Transforming Medical Research with Electronic Health Records

Dr Rebecca Daniels Kush
iHealth Connections, 2011;1(1):16–20
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Abstract

In the global world of clinical research, it is the Clinical Data Interchange Standards Consortium’s (CDISC) vision to inform patient care by improving data quality and patient safety. This article reflects on the impact electronic health records could potentially have on transforming medical research in the clinic. Specifically addressed are misperceptions or barriers that must be hurdled to achieve a common goal—to accelerate the cycle through which research informs healthcare and thus the opportunity to bring new therapies to patients sooner.
Acknowledgment: The author would like to acknowledge the expertise and contributions of Landen Bain, CDISC. This progress would never have been made without his diligent efforts.
Disclosure The author has no conflicts of interest to declare.
Correspondence: rkush@cdisc.org

Despite the explosion in new technology and re-engineering in other industries, the clinical research process has not changed substantially in the past two decades. The dated ‘traditional’ way that clinical studies are conducted today has imposed such a burden on many clinicians and potential investigators that they are unwilling to participate. The capacity for research is not keeping up with the demand for new knowledge. Woodcock and Giffin argue that the clinical trial system is currently at capacity and will not be able to support additional research, such as that for comparative effectiveness, unless resources are diverted.1 It has been estimated that the length of time to translate research findings into informed medical decisions is around 17 years,2 and it will only become a more cumbersome process with the voluminous clinical genomics information that is emerging—unless dramatic changes are made.

There is now an unprecedented opportunity to truly transform (not just ‘tweak’) the overall research process. One launch point is to leverage current trends to encourage the adoption of electronic health records (EHRs) in the US and many other countries, while another lies in the increase in the number of patients willing to voluntarily provide their health information for research purposes. Standards to improve information exchange and profiles to integrate research workflow into healthcare practices are already available to support such measures.3

What is holding us back? Unfortunately, misperceptions around the use of EHRs and personal health records (PHRs) for research abound, and there is either a lack of awareness of the new opportunities available or a resistance to adopt transformative measures over the status quo; these misperceptions (perceived barriers) continue to impede a ripe opportunity to transform research, and therefore, to hasten new therapies to patients.

Before delving into the details, it should be clarified that using EHRs to conduct clinical research studies should not be confused with harvesting claims data to seek safety signals or harvesting EHR data for insight into the current use of prescription medications. In other words, it is not ‘all about the data’. Instead, accelerating research will require process changes (integration profiles), standards (data sharing enablers), and the trust and willingness to support a true transformation in the current clinical research process. Fortunately, the first two of these requirements have been developed over the past decade (based upon global standards, regulations, and good clinical practices [GCPs]) and are now readily available; progress around the third requirement is gaining momentum in certain circles.

References:
  1. Giffin RB, Woodcock J, Comparative effectiveness research: who will do the studies? Health Affairs, 2010;29(11):2075–81.
  2. Balas EA, Boren SA, Managing clinical knowledge for healthcare improvement. In Yearbook of medical Informatics 2000. Patient-Centered Systems. Bemmel J, McCray AT (Eds), Schattauer Verlagsgesellschaft: Stuttgart, 2000:65–70.
  3. Kush RD, What the patient should order, Science Translational Medicine, 2009;1(3),1–5.
  4. Friedman CP, Wong AK, Blumenthal D, Achieving a nationwide learning health system, Science Translational Medicine, 2010;2(57):1–3.
  5. Castillo M, Time Magazine, 17 February 2011. Available at: www.time.com/time/business/article/0,8599,2049826,00 .html - ixzz1EFWNLlfr (accessed April 21, 2011).
  6. Getz K, Current investigator landscape poses a growing challenge for sponsors. The impact report, Tufts Center for the Study of Drug Development, Tufts University, 2009;11(1):3.
  7. CDISC eSource Data interchange document. Available at: www.cdisc.org/esdi-document (accessed April 21, 2011).
  8. European Medicines Agency, Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials. Available at: www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/08/WC500095754. pdf (accessed April 21, 2011).
  9. RFD integration profile, IHE. Available at: http://wiki.ihe.net/index.php?title=Retrieve_Form_for _Data_Capture (accessed April 21, 2011).
  10. EHRA RFD Endorsement Letter. Available at: www.cdisc.org/stuff/contentmgr/files/0/f5a0121d251a348a87466028e156d3c3/miscdocs/ehra_cdisc_endorsement_le tter_100908.pdf (accessed April 21, 2011).
  11. CDISC Healthcare Link Initiative. Available at: www.cdisc.org/healthcare-link (accessed April 21, 2011).
  12. Linder JA, Haas JS, Lyer A, et al., Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting, Pharmacoepidemiology and Drug Safety, 2010;19:1211–5.
  13. PatientsLikeMe. Available at: www.patientslikeme.com (accessed April 21, 2011).
  14. Terry SF, Terry PF, Power to the people: Participant ownership of clinical trial data, Science Translational Medicine, 2011;3(69):1–3.
  15. Kwak YS, Dickerson A, Just what the doctor ordered: the benefits of health informatics, ISO Focus, 2009;6:35–7.
  16. Bleicher P, Secondary use of electronic health records: A personal perspective, DIA Global Forum, 2010;2(6):25–8.
  17. Tcheng JE, Nahm M, Fendt K, Data quality issues and the electronic health record, DIA Global Forum, 2010;2(6):36–40.
  18. Ten Questions for Private Access. Forbes (2009). Available at: www.forbes.com/2009/09/08/private-access-tenquestions-entrepreneurs-promising.html (accessed April 21, 2011).
  19. Strategic Health IT and Advanced Research Projects (SHARP). Available at: http://healthit.hhs.gov/portal/server.pt/community/strategic_health_it_advanced_research_projects/1436/home/169 79 (accessed April 21, 2011).
  20. President’s Council of Advisors on Science and Technology, Report to the President Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward. Available at: www.whitehouse.gov/sites/default/files/microsites/ostp/p cast-health-it-report.pdf (accessed April 21, 2011).