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. DISRUPTIVE
INNOVATIONS
Point-of-care recruitment
Study eligibility
criteria
Electronic
Health Record
Match

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. 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. DISRUPTIVE
INNOVATIONS
The Patient Recruitment Challenge
Finding the right study for the right
patient at the right time

6. DISRUPTIVE
INNOVATIONS
Towards a Solution: clintrials.gov
DISRUPTIVE
INNOVATIONS

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. DISRUPTIVE
INNOVATIONS
A proposed solution:
Clinical Study Alerts

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. DISRUPTIVE
INNOVATIONS
Where to go from here...
Patient Registries?
Electronic
Health Record
Match
Product Safety?
REMMS?
Clinical Decision
Support?
Product Label
Information?

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.