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Finances for Clinical trial- SETUP/ MEET
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CLINICAL RESEARCH STUDIES
Budget

• Money to be spent during the forthcoming
  financial year
• Officially agreed by the Management committee
• The proposal of current year, becomes budget
• of subsequent year
• Should be final then fixed in databases
  (abacus)
• Budget figures are collected monthly expected
  yearly
• Cost can be estimated, through interpolation

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WHAT TO MEASURE
Person

• Factors
• 
  

Time
Costs
Setting
Tasks
Patients
Protocols
Revenue
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ASSESS FINANCIAL VIABILITY

• Time Commitment
• Administrative Start Up
• PI Supervision
• Initiation Visit
• Site Visits
• Monitoring Visits
• Follow Up Visits
• Drug Administration
• Investigator Meeting
• Close Out Visit
• Screening
• Screen Failures
• CRF Completion
• Adverse Event Reporting

• Other Costs
• Tests
• Patient Reimbursement
• Equipment
• Supplies
• Advertising
• Hospital Charges
• IRB Fee
• Overhead (10-35)

• Personnel
• PI
• Nurse
• Coordinator
• Admin Asst
• Lab Technician
• Statistician
• Radiologist

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FACTORS IMPACTING ON THE STUDY BUDGET

• Thinking and Knowing
• Study procedures length and complexity
• Outpatient vs inpatient
• Duration of treatment
• Case Report Forms length and complexity
• Centralized services laboratory, diagnostic
  imaging
• Institute Overhead
• PI reputation and relationship with sponsor
• Know Justify your costs .

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CLINICAL RESEARCH STUDIES
Objectives

• Identify your resources
• Describe associated costs
• Demonstrate how to write a internal budget
• Identify hidden costs
• Identify the elements of budget (as sponsor/
  third party)
• Describe post award activities related to payment
  and budget changes

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CLINICAL RESEARCH STUDIES
Internal cost External cost CRO cost
Database
SMART
Pillar
Collaborative collection

• The purpose of database is to include
  international
• Domestic studies to know estimate, proposal
  actual (SMART)
• Each study can be grouped as
• Bay No 6.
  Country
• Impact No
• Phase Clinical Project plan
• Objective
• Region

7. Budget ID
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CLINICAL RESEARCH STUDIES
Database
EXTERNAL
INTERNAL
Personal Overheads Travel Licensing
Allocations
CRO costs Investigator Payment Trial Related
expenses
Man Years

Medical Med Info Regulatory Drug Safety Clin
ops
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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?

• Type of the trial, national or international ?
  Cost of IRB ?
• Phase III or PMS study
• ICH-GCP or ICMR
• CRO or in house
• Time allocated as per protocol
• Selection of appropriate centers Investigators
• Audit planned ( in-house or FDA )
• Investigator meet SOPs

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CHALLENGES FOR THE SITE

• Protocols are becoming very complex and longer
• Patient recruitment remains the biggest challenge
• Average 6 of budget devoted to recruitment
• 86 of all trials do not meet enrollment
  expectations
• Sponsors routinely push to increase speed of
  performance
• Clinical Research Coordinator support
• Developing the study budget
• Not viable or realistic to support infrastructure
  or be profitable
• Meeting the sponsors project milestones
• Institutional requirements
• IRB turnaround

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COMMERCIALLY VIABLE SITE

• Better communications between site and sponsor to
  ensure a viable partnership
• Sharing important clinical information about the
  study
• Better monitoring through site preparation
• Faster data collection and query resolution
• Faster payment stay on top of this
• Of concern to 63 of sites and its getting worse
• Last payment can take up to 18 months to receive
• Hold-up 20 of budget until data lock
• Improve relationships Dont kill the goose

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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?
Type of the trial, national or international ?

• In general phase III regulatory studies adopt to
  local
• protocol relatively less expensive
• Simultaneous phase II/ III trials are based on
  total
• compliant model and hence there is no compromise
  on quality hence more money

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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?
Type of the trial, phase III or PMS ?
PMS protocols are simple SMART hence cost of
study can be reduced nearly to half
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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?
Type of the trial, ICH-GCP or ICMR
All ICH-GCP trials are more cumbersome
expensive due to more more documentation
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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?
CRO or in-house
Most of the studies involving third party to
conduct trial would involve additional fee
towards their expertise provision in-house CRA,
can have more advantage in term of speed cost
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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?
Time allocated as per protocol
Most of the time the duration would depend on
treatment modality even the rate of enrolment.
The indirect implication of cost can be more
adverse events which should be trapped after
signing contract ( more site visits )
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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?
Selection of appropriate centers Investigators

• Proper selection of centers is essential. Lack
  of infrastructure can be more expensive
• Investigators can be paid differentially as per
  their experience and city (Financial agreement is
  not to be disclosed like confidentiality
  agreement )
• Explain the proper cost to investigator (TDS
  Service tax, included in package )

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Recruitment

• Barriers and Challenges
• Patient attitudes community standards,
  individual psychosocial factors about healthcare
  research, and negative publicity
• Provider attitudes pressure from sponsor to
  recruit, inclusion/exclusion criteria, uneven
  recruitment planning
• Sponsor attitudes unaware of research subject
  attitudes, pressure to develop new drugs in a
  timely and cost effective manner

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RecruitmentMirage

• Recruitment flaws are the leading cause of
  clinical research failure(Funneling )
• Lasagnas Law (Louis Lasagna, Tufts University)
• Muenchs Postulates, Laws Corollaries
• Investigators overestimate the pool of available
  patients who meet inclusion criteria that are
  willing to participate in clinical research.

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CLINICAL RESEARCH STUDIES
Planning a budget for a clinical trial?
Audit planned (In-house / FDA)

• Audit of the sites would require additional
  resources from CRO hence additional cost as it
  would involve travel in addition to more hours
  with investigator
• FDA audit would require proper preparation of
  site as well the rehearse as per dummy audit
  (not necessary as per SOP)

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CLINICAL RESEARCH STUDIES
Infrastructure Costs Non-refundable

• IRB Institutional Review Board fees will be
  assessed whether the protocol is approved or
  not, and whether or not any participants are
  enrolled

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CLINICAL RESEARCH STUDIES
Institutional Review Board Fee Schedule
IRB Application Review Required IRB Fee New
Submission Full Committee
- New Submission Expedited
- Annual Renewal Full Committee
- Annual Renewal Expedited
- Sub. Amendment Full Committee
- Sub. Amendment Expedited
- No IRB fee charged for tech. amendment
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CLINICAL RESEARCH STUDIES
Advertising
Costs for advertising, as defined in SOP , for
adequate patient screen/ recruitment , are
usually described in the budget as an item to be
invoiced separately There should be direct
payment by sponsor
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CLINICAL RESEARCH STUDIES
Patient Compensation

• Compensation to be paid to participants is
  usually described in the budget as a line item
  (proper patient
• Insurance)
• Proper investigator insurance as per the issues
• addressed in the study

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Hidden Study Costs

• Delayed start
• Informed consent process
• Increased salaries operating costs over time
• Travel to distant sites

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Hidden Study Costs

• Unscheduled visits
• Tracking study funds
• Audit costs

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Hidden Costs

• Line items that are not included on the study
  flowchart or the sponsors budget template
• A real cost is incurred by the PI
• These include
• Dry Ice
• Record Storage includes optimal conditions
• Copies of Scans

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Final costing

• Sign proper Confidentiality agreement with all
  investigators CRO
• Sign proper financial agreement with all
  investigators CRO
• Sign proper financial agreement with Central labs
  
• TDS service tax should be accounted for
• All the expenses incurred at each sites should be
  filed
• Proper budget for IRB SRS
• Payment mode can be initially 40
• 30 on 50 completion of study
• 30 on 100 completion of study
• Costs on Data Management
• Statistical analysis through SAS
• MRR costing (completion, approval)
• Publication cost / Dossier cost
• Additional cost for monitoring drug safety or
  HEOR

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Protocol number Drug Name Investigators
Meeting (11th 12th, Nov 2005)

• Trial Title Multi centre controlled study of
  XYZ in patients in Hypertension

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Purpose

• Routine Investigators Meeting as an official
  start-up of the study
• To ensure both investigators, CRO and Bayer
  staffs well understand and compliant with study
  protocol, implementation procedures, Bayer SOP
  and ICH GCP

Location

• Hotel XYZ (4-5 star) or a resort
• Corp. Price 4000 Rs taxes / Room

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Brief Background

• ICDP Study
• Study Management CRO / Singapore Regional Office
• India 4 sites involved
• Monitoring In-house / Local Clin Ops team
• Co-operating Vendors (CROs)
• Data Management and Report Writing
• Consultancy and co-monitoring
• Central Lab for PK sample management

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Meeting Agenda

• 13.00 13.15 Welcome Remarks AP Medical Director
• 13.15 13.45 Study Management StM
• 13.45 14.30 Update GCL /
  GPL
• 14.30 15.15 Condition drug CI
• 15.15 15.30 Break
• 15.30 17.00 Protocol review ME / Stats.
• 17.00 17.30 Q A All
• 17.30 18.15 GCP Audit PM CRO)
• 18.15 18.30 Wrap-up AP Medical Director
• 19.00 20.30 Group dinner

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Attendees - Speakers
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Cost of Hospitality

• Lunch buffet and snacks during break 1500 Rs /
  Day / Person
• Group Dinner (04/Nov)
• 2000 Rs per Person
• Gift - 500 - 1000 Rs / Attendee (should be
  within corporate compliance)

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In clinical research, a site needs to anticipate
that the time and effort necessary to
successfully complete a study will be
significantly greater than it would be to treat a
similar number of regular-practice patients. The
site must negotiate a budget that provides
adequate reimbursement for that extra time and
effort. The Investigators Guide to
Clinical Research Dr. David Ginsberg
Centrewatch
Basic to Remember
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Costing templates are the individual company
domain They should reveal transparency , when
audited for the similar molecule Protocols are
different
The costing templates should give proper breakup
, not only for Running year, but also for the
subsequent years