A Peek at Dpharm 2012


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A Peek at Dpharm 2012

  1. 1. DISRUPTIVE INNOVATIONS Bringing Clinical Research into Clinical Practice Targeted Patient Recruitment at Point of Care Joris van Dam, Strategic Projects Leader, Novartis Pharmaceutical Development
  2. 2. DISRUPTIVE INNOVATIONS Point-of-care recruitment Study eligibility criteria Electronic Health Record Match
  3. 3. DISRUPTIVE INNOVATIONS The Patient Recruitment Challenge • Over the last 15 years, the actual R&D spend per drug was $ 3.6-11.7 Bio(1) • Per-patient clinical trial costs have risen an average 70% in 2008-2011(2) • The global annual spend on Phase I-III clinical trials is >75 Bio(3) • In the UK, 30% of investigative sites fail to recruit a single patient and 70% fail to meet recruitment targets(3) Sources: (1) InnoThink Center For Research In Biomedical Innovation; Thomson Reuters Fundamentals via FactSet Research Systems; Forbes Feb 2012 (2) Cutting Edge information, “Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design,” published July 15, 2011 (3) PAREXEL Bio/Pharmaceutical R&D Statistical Sourcebook 2011/2012
  4. 4. DISRUPTIVE INNOVATIONS The Patient Recruitment Challenge • Only about 2% of the United States population and 4% of physicians ever get involved with clinical research(1) • A recent study showed that less than 5% of Americans know where to find information about relevant clinical trials(2) • 57% of Americans say they would be likely to participate in clinical research(3) Sources: (1) Center for Information & Study on Clinical Research Participation (CISCRP) (2) Ken Getz, “The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial”, October 2008 (3) Charlton Research Company, “Transforming Health, Fulfilling the Promise of research”, November 2007
  5. 5. DISRUPTIVE INNOVATIONS The Patient Recruitment Challenge Finding the right study for the right patient at the right time
  6. 6. DISRUPTIVE INNOVATIONS Towards a Solution: clintrials.gov DISRUPTIVE INNOVATIONS
  7. 7. DISRUPTIVE INNOVATIONS Towards a solution: Health IT US Physicians With Electronic Health Record (EHR) Systems, 2002–11. Decker S L et al. Health Aff doi:10.1377/hlthaff.2011.1121
  8. 8. DISRUPTIVE INNOVATIONS A proposed solution: Clinical Study Alerts
  9. 9. DISRUPTIVE INNOVATIONS Proof-of-concept project: approach Clinical Study Protocol Eligibility criteria Interface Study Sponsor EHR Vendor Match to Patient Record Display at Point of Care Study Sponsor Study Sponsor EHR Vendor EHR Vendor
  10. 10. DISRUPTIVE INNOVATIONS Where to go from here... Patient Registries? Electronic Health Record Match Product Safety? REMMS? Clinical Decision Support? Product Label Information?
  11. 11. DISRUPTIVE INNOVATIONS We have an opportunity, and an obligation, to better inform patients and physicians about the opportunities they have to volunteer for clinical research. The Clinical Study Alert system has the potential to provide such information, personalized to the patient's individual medical history, and presented at the point of care.