Transcript Research in Clinical Practice: Risk or Reward

Tracking Budgets &
Trolling for Grants
Colleen Schmitt, MD, MHS
Medical Director, Southeastern Clinical Research
Galen Medical Group
Chattanooga, Tennessee
Why Add Research to a Busy
Practice?
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Hjorth et al. Control Clin Trials 1996;17:372
Schmitt CM. J Clin Gastroenterol 2000;31:205
Increase knowledge about
diseases and therapies
Enhance image
Participate in scientific
process
Access to new therapies
Alternative revenue stream
Potential Revenue…How?
Understand costs
Understand payment structures
Meet or exceed quota
Hoping for a Piece
of the Pie
$45
Growth in R&D (Billions)
$40
$35
$30
$25
Domestic
Foreign
$20
$15
$10
$5
$0
1980 1990
2000
PhRMA. Pharmaceutical Industry Profile 2007.
2004 2005
2006
Drug Development Process
Phase
II
www.phrma.org
Phase
III
Phase
IV
Impact on Research
Practice
PhRMA Annual Report, 2001
Site Selection
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40% sites are new for any given trial
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How to tap into the pipeline?
91% top 25 Big Pharma use
word-of-mouth and networking
 56% use external directories
 64% use internal database
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CenterWatch 2001;8:1
Site Selection
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Good Clinical Practice (GCP)
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www.barnettinternational.com
www.socra.org
SCR GCP update @ utcomchatt.org
Ability to deliver
Therapeutic area expertise
Strong reputation
Starting from Scratch
 Track leads and sources
• Feasibility questionnaires
 Site CV’s and profile
• Target: therapeutic area, sponsor, CRO
• Metrics: enrollment, time to quota
 Estimate site costs for activities
• Fee-for-service basis
• Hourly basis
List Site or Profile
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www.centerwatch.com
Study Brokers
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www.invlocate.com
www.researchsite.net
www.clinicalinvestigators.com
Site Management Organizations (SMO)
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www.americasdoctor.com
stark-smo.com
smo-usa.com
Sites last accessed 05.July.2007
Sample Lead Sources
Vendor
 R & D Directions
 CenterWatch
 PhRMA
 NDA Pipeline
 Clinical Investigator
News
 Drug Development
Pipeline
Website
 www.biz-lib.com
 www.centerwatch.com
 www.phrma.org
 www.fdcreports.com
 www.ctbintl.com
 www.biopharminsight.com
Protocol Considerations
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Science
Safety
Feasibility
Interest
Financial
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Schmitt CM. Gastrointest Endosc Clin N Am 2006;16:751
Sponsor
Opportunity for
future work
Idea for compound
Therapeutic area
Monitoring group
Meeting quota:
Good Clinical Practice
ECOG study
62% investigators did not enroll any
study subjects over the 1st year of study
 80% study subjects enrolled by 10%
investigators
 Fewer subjects=more errors
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Taylor KM, et al. J Clin Oncol 1994;12:1796
Rules of Thumb for Budget
Everything is negotiable
 Start with the protocol
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Use the visit spreadsheet as rough
draft
 Scrutinize for undescribed work
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Meeting Quota:
Good Business
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Revenue
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Simple GERD trial
Budget = $1200 per subject, quota = 10
Costs = $800 per subject + $1350 start-up
$30,000
$20,000
Gross
Net
$10,000
$0
4
6
8
10 12 14 20
#subjects enrolled
Fee for Service
Full physical examination @ $200
 Brief physical examination @ $100
 Endoscopic procedures @ $1200
 Pelvic examinations @ $200
 DEXA scans, CXR, EKG @ $$
 Coordinator visit @ $100
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Budget Template
Procedure
# $ per
Full PE
2
200
400
Brief PE
4
100
400
EKG
2
25
50
Lab draw
6
25
150
Other visits
4
100
400
DEXA
2
200
400
Total Per Patient
$ Total
$1800
Coordinator Costs
Base salary varies by
education, experience,
ACRP (www.acrpnet.org)
geography
DIA (www.diahome.org)
 Benefits 25% base salary
 Time: long term studies (> 6 mos.),
electronic CRF, adverse events,
protocol amendments
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Where the Money Goes
Indirect Costs
Pre-study Costs
Lease, telephone, FAX,
computers, postage, banking
Travel, protocol review, contract and
budget negotiation, regulatory,
advertising
During Study
Study visits, procedures, monitor
Costs
visits, CRF completion, medications
Post-study Costs Query resolution, study close-out
What’s Negotiable?
Advertising
$2000-3000 (ph. III, chronic disease)
Beware central advertising
Protocol
Regulatory resubmission, extra visits,
Amendments adverse events
Up-front
payments
1-2 patients or 20%
Final
payment
1 patient or 15%
Overhead
20-25%
Anything Else?
Ancillary personnel
 Adverse events
 Specimen retrieval for central review
 Revisions to Case Report Forms (CRF)
 Follow-up laboratory evaluation
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Money Pits
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Overnight mail
On-site labs (pregnancy test, U/A)
Long term document storage
Attendance at investigator’s meeting
Telephone follow-ups and reminders
Electronic data collection
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50% > than paper CRF
Query resolution
Specimen retrieval
Negotiate for Success
Communicate effectively
 Base budget on protocol
 Know your costs
 Know your community and patient
population
 Understand your prior experience
 Know when to say “no, thanks”
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Accounts Receivable
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Beware scam payment systems
based on
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Blocks of patients
Query resolution at other sites
Database closure
Invoice frequently
Document all communication
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Who, what, when, how
Is the Future Rosy?
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1994 1996 1998 2000 2002 2004 2006
PhRMA. New Drug Approvals in 2006
http://www.fda.gov/cder accessed 05.July.2007
Drugs
Biologics
New Drug Approvals, 2004
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Of 29 Approvals in 2006, GI included:
Amitiza® (lubiprostone)
 Pylera™ (biskalcitrate, TCN,
metronidazole)
 Sutent® (sunitinib)
 Tyzeka® (telbivudine)
 Veregen™ (kunecatechins)
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PhRMA. Pharmaceutical Industry Profile 2006.
More About the Future
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Medicare Prescription Drug,
Improvement, and Modernization
Act of 2003
Increased exportation of drug
development in all clinical
phases
Increased generic share in the
marketplace
Importation of drugs via borders
and internet
Learning curve in litigation
Summary
Lead by example
 Learn and live by
Good Clinical Practices
 Be responsible
 Get involved
 Require excellence
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“There are some things you learn
about swinging a cat by the tail
only by swinging a cat by the tail.”
Mark Twain (paraphr.)
Tom Sawyer, Abroad