Transcript Budget webinar for Industry studies

PRCSG Training Webinar: Budget
for Industry Sponsored Studies
Anne Johnson, Senior SpecialistProject Management
Cincinnati Children’s Hospital
Call in: 1-866-629-4752
Passcode 502017#
Outline
• Start up costs overview
• Comparative start up costs – 3 clinical
trials
• Routine study visit costs
• Conclusion
Start up costs (1)
• IRB fees
– Average initial submission for a local IRB $3500
– Average fee per amendment approval $1250
– Average fee for continuing review $2000
– The initial submission fee and the time/labor costs
needed for the submission packet to be completed are
usually included in the start up costs provided before
the study starts.
– The amendment and annual review fees usually have
to be invoiced separately as they occur.
Start up costs (2)
• Pharmacy fees
– Average start up fees for investigation pharmacy are
$3,500.
– Every visit usually incurs an additional dispensing fee.
– Check with your pharmacy about fees for drug
reconciliation and policies for return of used and
unused drug at every study visit.
– Pharmacy staff should take care of their own
delegation log and study forms for drug receipt,
dispensing, reconciliation, and destruction.
Start up costs (3)
• Administrative start up fee can range from 5-10K
depending on the sponsor.
– Regulatory coordinator time to collect and file
necessary “reg docs” (1572, delegation log, CVs,
licenses, HSP training, financial forms)
– Time needed to write consents per site and sponsor
templates, IRB submission documents
– Training followup for protocol, IB, pharmacy manual
for all staff listed on the delegation log
Start up costs (4)
• Will you use a clinical trial research center? Costs
and time for application.
– Sometimes the CTRC requires a protocol application in
addition to the IRB submission.
– The hourly costs for CTRC use can either be under
your “other costs” section of the contract (need to be
invoiced) or included in the patient per visit costs.
“Other costs”
• Some contracts will offer close out fees as well
as start up fees.
• Check your contract for other costs that must be
invoiced to collect payment.
– Screen failures
– pK sampling if not included in the patient visit costs
Comparative start up costs by sponsor
A
B
C
Local IRB fees
$3,500
actual
$4,000
IRB amendment fee
$1,250
actual
actual
IRB annual review
$2,000
actual
actual
$10,385
$12,750
$6,500
none
$1,200
none
$2,500
$2,000
none
Lab set up
none
$550
none
Screen fails
$921
actual
$1,619
Close out fee
none
$2,500
none
$40
$300
$95
none
$1,360
none
$20,596
$20,660
$12,214
Admin start up
IRB document prep
Pharmacy start up
Additional samples
Record retention
Total start up costs
Routine study visit costs
• Schedule of events should be broken down by
visit in the contract to show what needs to be
done when and how much the sponsor will pay
for the activity.
• These costs are usually paid directly once the
visits are completed and entered into the EDC.
No invoice is needed to collect these payments.
• It is a good idea to double check these activities
with your clinic practice procedures. Most
hospitals require a breakdown of research vs.
standard of care charges for study visits.
Routine study visit typical costs (1)
• Informed consent/parent permission/assent and
complete medical history
$150-$200
• Uveitis assessment (slit lamp exam)
$100
• Complete physical exam (baseline and pivotal
time points)
$300-$400
• Partial physical exam (other time points)
$250
• Tanner stage (usually done twice-baseline and
last visit)
$75-$100
• Quantiferon-TB (blood test) done at baseline or
screening visit and possibly yearly
$75-$100
Routine study visit typical costs (2)
• Complete joint evaluation by certified assessor
(sometimes blinded depending on protocol)
$75-$125
• Physician Global Evaluation of Overall Disease
Activity
$50-$75
• Subject Reported Outcomes
– CHAQ
– CHQ
– PedsQL
– Pain and global evaluations
$35-$50
Routine study visit typical costs (3)
• ESR or CRP (marker of inflammation)- this could
be onsite testing or collection and shipping to
central lab, prices vary by process
$25-$50
• Sample collection, processing, and shipping for
central lab
$50-$80
• Study Treatment management
– Review patient diary, answer questions
– Collect used/unused IP, reconciliation records
– Pharmacy orders and returning used/unused IP
– Dispense new IP to patient
$85-$100
Routine study visit typical costs (4)
• Study Treatment management (continued)
– If IP is by injection, some protocols require that the
subject administer while in clinic and then wait 30
minutes for repeat vitals
– If IP is by infusion, this extra cost for CTRC or infusion
center might be included in the visit charge or might
be listed under “other costs”. Make sure the cost of the
infusion is listed somewhere in the contract. Typical
infusions take 30-60 minutes and then need repeat
vitals.
Routine study visit typical costs (5)
• Study Coordinator Fees
– Confirming eligibility criteria with PI
– Consenting procedures
– Prior/concomitant meds
– Vital signs, height, weight, possible repeat vitals after
IP administration will be needed
– Randomization
– Submitting assessments to PRCSG for some studies
and some visits
– AE/SAE review, monitoring with PI
$150-$200
Routine study visit typical costs (6)
• Data entry into EDC
$100-$150
• Subject/caregiver travel reimbursement (depends
on protocol and time spent on site)
$50-$100
• PK sampling might be part of protocol
$40-$50
• Urine or blood pregnancy tests for WOCBP,
depending on protocol, every time new IP is
given or as requested by sponsor
$50
Routine study visit typical costs (7)
• Total costs should be listed per visit and then per
patient
• Costs should be listed with and without overhead
Conclusion
–Repeat webex September 13, 11am
–Questions?
–Comments?
–Proposed topics for future webex
training?
–[email protected]