Medical Informatics Perspectives on Pharma eClinical: Leveraging EMR Expertise

1. Medical Informatics Perspectives on Pharma eClinical: Leveraging EMR Expertise Scot M. Silverstein, MD Assistant Professor of Healthcare Informatics and IT Director, Institute for Healthcare Informatics Drexel University, College of Information Science & Technology March 14, 2006

2. Goals: • Promote better understanding of Medical Informatics as a formal, cross-disciplinary clinical/IT specialty, lift veil of mystery that leads to misuse of term. • Raise awareness of national eClinical (EMR) initiatives on the provider side, and how these are important to pharma. • Provide insights into how Medical Informatics experience in solving provider sector EMR issues is valuable towards parallel issues in pharma eClinical and other R&D IT initiatives.

3. The iSchools Focus is on how people seek, use or interact with information using technology, not simply on technologic devices and computer programs. • University of California, BerkeleySchool of Information Management and Systems • University of California, IrvineThe Don Bren School of Information and Computer Sciences • University of California, Los AngelesGraduate School of Education and Information Studies • Drexel UniversityCollege of Information Science and Technology • Florida State UniversityCollege of Information • Georgia Institute of TechnologyCollege of Computing • University of Illinois Urbana-ChampaignThe Graduate School of Library and Information Science • Indiana UniversitySchool of Informatics • Indiana UniversitySchool of Library and Information Science • University of MarylandCollege of Information Studies University of MichiganThe School of Information University of North CarolinaSchool of Information and Library Science The Pennsylvania State UniversitySchool of Information Sciences and Technology University of PittsburghSchool of Information Sciences Rutgers, the State University of New JerseySchool of Communication, Information, and Library Studies Syracuse UniversitySchool of Information Studies University of Texas, AustinSchool of Information University of TorontoFaculty of Information Studies University of WashingtonInformation School

4. Guiding Principles: • Clinical IT will significantly benefit healthcare quality, efficiency and costs only if done well. • People issues are as critical towards success of clinical IT initiatives in the provider sector as well as in pharma.

5. Gartner Predicts 2006: Life Science Manufacturers Adapt to Industry Transitionshttp://www.gartner.com/DisplayDocument?doc_cd=134309 • The swift and severe judgment in favor of the plaintiff in the first Merck Vioxx trial sent a shock wave through the biopharma industry.  It shows that biopharma manufacturers must do more to ensure that healthcare providers and the public have an accurate, ongoing assessment of medication risks.  Biopharmas must also ensure that information on these risks is communicated promptly in an open, understandable manner.  Posting clinical trial information on a web site is one step towards greater transparency, but does not provide information in a way that [easily] enables ... comparisons of benefits and risks. • ... It is still well recognized that all the possible side effects of a medication cannot be uncovered using [only] a randomized sample of study subjects.  The true test of [long-term] safety and efficacy can only be determined when trial data is combined with other sources of information such as clinical encounters, adverse events (MedWatch) or observational studies (National Registry of Myocardial Infarction). • In the future, it is hoped that the EMR system will capture point-of-care information in a standardized format that can be used for drug surveillance.  Today, biopharmas must be content with these other available, if imperfect, information stores.

6. Gartner Predicts 2006 (cont.) • Biopharmas ... should look at risk from multiple perspectives ... they must also get actively involved in defining the electronic health and medical record so that it will contain the type of information required to make better safety assessments in the future. • Biopharmas that ignore the opportunity to use analytical tools to proactively review contradictory sources of study information (for example, pre- and post-approval clinical data sets, as well as registries) will miss essential signals regarding product safety. Yet today, only a small percentage of biopharmas routinely utilize personnel with medical informatics backgrounds to search for adverse events in approved drugs.

7. What is Medical Informatics? • Medical Informatics studies the organization of medical information, the effective management of information using computer technology, and the impact of such technology on medical research, education, and patient care. • Formal, NIH-sponsored field on which NIH has provided many millions of dollars in training grants for ~ the last two decades. • Nearly invisible to pharma. Why?

8. The Informatics Subspecialties

9. NIH training programs in Medical Informaticshttp://www.nlm.nih.gov/ep/GrantTrainInstitute.html 1-Harvard-MIT Division of Health Sciences & Technology, 2-Yale University, 3-Columbia University, 4-University of Pittsburgh, 5-Johns Hopkins University, 6-Medical University of South Carolina, 7-Vanderbilt University, 8-Indiana University - Purdue University at Indianapolis, 9-University of Wisconsin Madison,10-University of Minnesota Twin Cities, 11-University of Missouri Columbia, 12-Rice University, 13-University of Utah, 14-University of California Irvine, 15-University of California Los Angeles, 16-Stanford University, 17-Oregon Health & Science University,18-University of Washington (training is provided by other universities via internal funds as well).

10. Why is Medical Informatics Important? • A number of very expensive healthcare IT project difficulties and failures have appeared in the literature in recent years in large part due to organizational change resistance, internal political struggles, lack of expertise in IT implementation processes most suitable for clinical environments, and other sociotechnical issues. • Cedars-Sinai Hospital in Los Angeles [Doctors pull plug on paperless system. American Medical News, Feb. 17, 2003] • Hospital of the University of Pennsylvania [Role of computerized physician order entry systems in facilitating medication errors. Koppel et al., JAMA 2005;293(10):1197-203] • VA hospital CoreFLS failure - $472 million [http://www.usmedicine.com/article.cfm?articleID=932&issueID=66] • United Kingdom NHS initiative [Doctors fear £6bn IT project will be a fiasco. The Guardian, February 8, 2005. [http://society.guardian.co.uk/internet/story/0,8150,1407903,00.html] • Others [website Sociotechnical Issues in Health IT: Common Examples of Health IT Failure] • Pharma examples – CRISP project - In the 1990s, [pharma] struggled to erect a modernized clinical data system known as CRISP (Clinical and Regulatory Information Strategic Program), a project that current and former information systems workers came to regard as a $100 million fiasco. "This project ran into a lot of problems," says one former manager who was involved near the beginning of the CRISP project. [http://www.baselinemag.com/article2/0,1397,1608582,00.asp]

11. Why is Medical Informatics important? • Clinical IT and its environment are core competence • Recognition that organizations are simultaneously social (people, values, norms, cultures) and technical (tools, equipment, technology). These elements are deeply interdependent and interrelated. Good design and implementation is not just a technology issue but also one of jointly optimizing the combined sociotechnical systems. • Medical Informatics training recognizes these issues and trains cross-disciplinary specialists accordingly. Curriculum example: • Fundamental of computer scienceMedical language and terminology systemsModeling of medical observations and dataMedical coding systemsMedical knowledge structuresInformation organization and flows in medical practiceQuantitative models for medical decision makingClinical decision supportMedical image processingUser interfaces and ergonomics in healthcareHealth information systems architectureSecurity and confidentialityEthical and legal issues in electronic medical recordsOrganizational and sociological issues in clinical IT projectsMetrics and methods for evaluating healthcare information systemsCost and investment issues in healthcare IT

12. National EMR Initiatives: U.S. • Transforming Health Care: The President’s Health Information Technology Plan • http://www.whitehouse.gov/infocus/technology/economic_policy200404/chap3.html • President Bush has outlined a plan to ensure that most Americans have electronic health records within the next 10 years. The President believes that better health information technology is essential to his vision of a health care system that puts the needs and the values of the patient first and gives patients information they need to make clinical and economic decisions – in consultation with dedicated health care professionals. • Office of the National Coordinator for Healthcare IT (ONCHIT)- established April 2004 • http://www.hhs.gov/healthit/

13. National EMR Initiatives: U.K. • National Programme for IT in the NHS • http://www.connectingforhealth.nhs.uk/ • The National Programme for IT, delivered by the new Department of Health agency NHS Connecting for Health, is bringing modern computer systems into the NHS to improve patient care and services. Over the next ten years, the National Programme for IT will connect over 30,000 GPs in England to almost 300 hospitals and give patients access to their personal health and care information, transforming the way the NHS works. • Described as “the world’s biggest government IT project”

14. Pharma takes notice: Integrating Patient Information with Drug Development Nov. 2005: Exploring the Opportunity for Collaboration with Drug & Device Firms in Accelerating IT Adoption by Hospitals & Physicians http://exlpharma.com/events/ev_brochure.php?ev_id=17 Speaking Faculty: Landen Bain, Healthcare Liaison, CDISC Michael Barrett, Managing Partner, CRITICAL MASS CONSULTING Brian Chadwick, Partner, LOOKLEFTGROUPSue Dubman, Director of Applications for the Center of Bioinformatics, NATIONAL CANCER INSTISTUTERobert N. Hotchkiss , MD , Director, Clinical Research, HOSPITAL FOR SPECIAL SURGERY Charles Jaffe, MD, Vice President, Life Sciences, SAIC Bill Johnson, President, WILLIAM S. JOHNSON CONSULTING Les Jordan, Life Sciences Industry Technology Strategist, MICROSOFT Stan Kachnowski, PhD, Professor, Health Information & Public Policy, COLUMBIA UNIVERSITY Becky Kush, PhD, President, CDISC Jim Langford, President, DATALABS Gary Lubin, Co-Founder, MERCK CAPITAL VENTURES Somesh Nigam , PhD, Information Management Director, Pharma R&D IM, JOHNSON & JOHNSON PRD Jerry Schindler, DrPH, President, CYTEL RESEARCH Steve Schwartz, Senior Vice President, Business Development, ALLSCRIPTS Martin Streeter, Partner, LOOKLEFTGROUP Barbara Tardiff, MD, MBA, Executive Director, Research Information Services, Clinical & Regulatory Information Services, MERCK & CO., INC. Cara Willoughby, Consultant, Scientific Communications/Regulatory, ELI LILLY AND COMPANY KEYNOTE PRESENTATION Improving Patient Care while Optimizing Efficiency: Outlining the Potential Benefits from Merging Patient Care and Drug Development EffortsBarbara Tardiff, MD, MBA Executive Director, Research Information Services, Clinical & Regulatory Information Services MERCK & CO., INC. HOSPITAL PERSPECTIVE: The Challenges and Limitation of Merging Electronic Health Information Robert N. Hotchkiss, MD Director, Clinical Research HOSPITAL FOR SPECIAL SURGERY STANDARDIZATION EFFORTS: Interchange Standards: The Key to Linking Healthcare and Clinical Research Information Rebecca Kush, PhD, President, CDISC Landen Bain, Healthcare Liaison, CDISC Sue Dubman, Director of Applications for the Center of Bioinformatics, NCI

15. Why is good clinical IT difficult? • Lindberg: “Computer Failures and Successes”, Southern Medical Bulletin 1969;57:18-21 • Computer experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information. • Nemeth & Cook: “Hiding in Plain Sight”, Journal of Biomedical Informatics 38 [2005], 262–263 • Just beneath the apparently smooth-running operations [of healthcare] is a complex, poorly bounded, conflicted, highly variable, uncertain, and high-tempo work domain. The technical work that clinicians perform resolves these complex and conflicting elements into a productive work domain. Occasional visitors to this setting see the smooth surface that clinicians have created and remain unaware of the conflicts that lie beneath it. The technical work that clinicians perform is hiding in plain sight. Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it. • Wears & Berg: “Still Waiting for Godot”, JAMA Vol. 294 No. 2, July 13, 2005 • Throwing IT at a health care system to remedy high medication error rates will not be effective unless the organizational reasons for those failures also are addressed. These reasons are hidden in the "messy details" of clinical work: complexity; uncertainty; conflicting goals; gaps in supplies, procedures, and coordination; brittleness of tools and organizational routines.

16. Case Study • What you didn’t want to know about clinical information technology in large medical centers: • Compare issues to your own project difficulties in pharma or CRO settings

17. The often divergent goals of three main groups within a medical center From Sittig DF, Sengupta S, al-Daig H, Payne TH, Pincetl P. The role of the information architect at King Faisal Specialist Hospital and Research Centre. Proc Annu Symp Comput Appl Med Care. 1995;:756-60

18. The Three Stakeholder Groups in More Detail Administration (purchasers) • CEO • COO • CFO • Gen Counsel • CIO • IT staff • Consultant • Clin leaders • (SVP, COS, • Dept. Chairs) • Clinicians • Service Mgr. Information Technology (implementers) Medicine (users)

19. The undesired dynamics Administration • CEO • COO • CFO • Gen Counsel • CIO • IT staff • Consultant • Clin leaders • (SVP, COS, • Dept. Chairs) • Clinicians • Service Mgr. Information Technology Medicine

20. Medical Informatics as Intermediary Administration • CEO • COO • CFO • Gen Counsel MI • CIO • IT staff • Consultant • Clin leaders • (SVP, COS, • Dept. Chairs) • Clinicians • Service Mgr. Medicine Information Technology

21. The desirable dynamics Administration • CEO • COO • CFO • Gen Counsel MI • CIO • IT staff • Consultant • Clin leaders • (SVP, COS, • Dept. Chairs) • Clinicians • Service Mgr. Medicine Information Technology

22. Medical Informatics role • Responsible for helping these three groups understand they are all working toward the same goal, and ensuring medical center personnel collaborate efficiently and productively. • Understanding and work with the stakeholder drivers (motivators) and dynamics (interactions) in detail will help the MI proactively intervene and avoid retrospective correction after problems have arisen.

23. Observed Drivers: Health System Administration

24. Observed Drivers: Information Technology (MIS)

25. Observed Drivers: Clinicians

26. Case highlights - Invasive Cardiology • 6,000 procedures/year. EDC system sought for new device and modality trials and evaluation, PI, benchmarking, operations reporting, inventory. • In house development/customization ruled out by CIO - turnkey policy - despite clinician judgment. • 2 year analysis, market investigation, K-T, business process as for accounting system.

27. Skepticism/fear/delay • Vendor product acquired but sat unused for almost a year before operationalization was considered - skepticism by CIO, COO, clinicians • Only .75 FTE's assigned. MIS person chosen had no experience working in tough, high-volume, critical care areas. Scared.

28. Beginnings of conflict • A Steering Committee was initiated, led by cardiac services executive relatively unfamiliar with IT • CIO, IT staff adamant that vendor product should not be modified even though clinicians wanted the data and workflow components of the package to be adjusted to their busy clinical environment and customs (rather than the other way around). • MIS department began to blame the physicians for being "non-cooperative" with them, stubborn, unable to finalize decisions about the package, and responsible for lack of project progress.

29. Conflicts increase • Cardiac services administrator blamed for "not controlling the doctors.” Pushed for install. • Unstable platform, kept crashing, losing data. • Attempted install in the cath lab went so poorly, and was so misaligned with needs, expectations, work flow, and the tremendous patient responsibilities, that the demoralized and frustrated cath lab staff demanded in a hostile tone that the MIS people "get out of our cath lab!" • Loud complaints to Chairs, Sr. VP Med Affairs, CEO • Large political battle in high revenue area (25%)

30. Medical Informatics as intermediary • Consultant called in; unable to resolve problems (fear of being tough). • COO / CFO skeptical of benefits of project altogether, wanted to kill project, $500K already spent, relations disrupted • Medical Informaticist hired by CEO/Sr. VP to mediate / resolve issues • MI investigates: finds many changes needed, creates 10-point plan and phased timeline oriented to clinical realities

31. Remediation begins • Move to stable platform suitable for cath lab environment resisted by CIO & IT staff due to resources involved, but pushed through by informaticist through persuasion of key stakeholders, especially CEO, COO, Sr. VP • Informaticist created collaborative and participatory work team environment, a non-traditional methodology in MIS but crucial for clinical computing settings (Participatory Design of Information Systems in Healthcare, Sjoberg C, Timpka T: Journal of the Amer. Medical Informatics Assoc. 1998;2:177-183). • New IT “can-do’s” hired, increased independence from central IT control, again through persuasion

32. Remediation continues • Cardiologists given major input to steering committee and workgroups and report development • MI identified criticality of data remodeling for the cardiologist's needs - and led the effort (IT personnel or clinicians alone could not do) – core competency of MI. • New data model crafted collaboratively, consistent w/lab practices and national standards but far surpassing the latter to meet day-to-day needs. ACC dataset problems identified. • Dictation allowed to supplement case report generation so clinicians not “boxed-in”

33. Rapid improvement • Clinicians, service administrator, COO representative allowed to define statistical reports and definitions/terminology. • Meet desire for research data, performance improvement, operations improvement while allaying fears of inaccurate “report cards.” • Agile methodologies (e.g., iterative and incremental development) approach was SOP. Not as possible in pharma due to validation and other regulatory requirements, but some degree of avoidance of “process zealotry” and “methodological fanaticism” possible and advantageous • System in use within 6 months by 75% of staff, enthusiastic committee meetings

34. Success • System allowed improved scheduling, lab operations and staffing planning, outcomes assessment, participation in national initiatives- American College of Cardiology (ACC), Society for Thoracic Surgery (STS), and Genentech National Registry of Myocardial Infarction (NRMI). • Received recognition for excellence by national cardiology figures, and JCAHO. Source of conflict became source of pride. • Trust built with clinicians allowed inventory module to be rapidly implemented (months) • $1 million savings realized the following year.

35. Conclusions • Clinical IT projects are complex social endeavors that happen to involve computers, as opposed to information technology projects that happen to involve doctors. • An understanding of the internal personnel dynamics by the medical informaticist is an important asset towards facilitating success. • This understanding and experience should be [is] portable to pharma and can be of great value in eClinical initiatives and in collaborations with the provider side.

36. Additional Reading • Organizational Aspects of Health Informatics: Managing Technological Change. Nancy M. Lorenzi, Robert T. Riley (Springer-Verlag, 1995). • Advance for Health Information Executives: “Medical Informatics, Friend or Foe”, Robert Gianguzzi, May 1, 2002, p. 37-38

37. Dean Sittig, Director of the national Clinical Informatics Research Network (CIRN) for Kaiser Permanente: "There are many different constituencies, and hence views, which must be considered when attempting to develop an integrated clinical information management system in any large medical center ... we believe that without a full-time, on-site [medical informaticist], the difficulty of the task increases to the point of becoming nearly impossible."