Transcript Slide 1

Clinical Trials Submitted Successfully – Session #12
Heritage Gallery
Presenters:
Laura Williams – Sponsored Projects Administration
Debra Dykhuis – Office of Clinical Research
Bridget Foss – Sponsored Projects Administration
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Clinical Trials Trivia Time
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According to clinicaltrials.gov, there are approximately
how many open clinical studies underway
in the state of Minnesota?
1,231
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Laura Williams – Feasibility Considerations
in Clinical Trials
Debra Dykhuis – Budgetary Considerations
in Clinical Trials
Bridget Foss - SPA Submission Processes and Shortcuts
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Feasibility Considerations in Clinical Trials
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Protocol Review
Considerations
Ethical Considerations
Business Considerations
Scientific Review
Institutional Review
Regents Policies
Certainly not to be ignored,
but not covered today:
FDA
GCP
ICH
Investigator-sponsored
clinical trials
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Protocol Review Considerations
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◦ Population
◦ Staff
◦ Space
◦ Technical capability
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◦ Cost per subject
◦ Complexity of protocol
◦ Duration of study
◦ Survivability
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◦ Adequate study design
◦ Main hypothesis
◦ Blinding, randomization
◦ Biostatistical methodology
◦ Endpoints
◦ Publishability
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Target population
Safety
Severity of disease
Availability of alternative treatments
Side effects
Peds / Elderly
Underserved populations
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Frequency and complexity of monitoring visits
Closeout visits
Funder resources and assistance during the trial
Working with the PI
Cost sharing
Multi-departmental
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CRO involvement
Past dealings with sponsor
History of timely payments (or not!)
SIV Process
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Publications
◦ University’s policies and continuing tax status are
dependent on fulfilling our threefold mission:
 Research and Discovery
 Teaching and Learning
 Outreach and Public Service
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Intellectual Property
◦ Terms must also be respondent to the University
research mission
◦ Principles of exercising academic freedom
Indemnification and Subject Injury
Payments
◦ Important to understand these are negotiable
◦ SPA will defer to the coordinator/PI
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To be performed by independent, peer
reviewers – no one from the research team
One of three methods must be utilized
1. Full peer review by grant committee of
NIH, NSF or a foundation – excludes
industry sponsored clinical trials; or
2. U of M scientific review committees; or
3. CPRC provides initial evaluation and
review of all University of Minnesota
clinical cancer research protocols, and
monitors and renews the protocols
annually. Those with low success may be
terminated.
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General Clinical Research Center (GCRC) Scientific Advisory
Committee – only if GCRC center is utilized
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Protocol Review and Data Use (PRDU) - protocols involving solid
organ transplant
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Interdisciplinary Site Specific Committee – translational
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Others – Surgery, OB/Gyn
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Any appropriately constituted departmental or collegiate – at least
two reviewers reach consensus on science, documentation of the
review process filed with the college-level associate dean
Required prior to IRB submission
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Openness in Research - Subd. 1
◦ The University shall not accept support from any source
for research under a contract or grant that prohibits the
disclosure of the research relationship, the nature of the
research…..
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IP Sharing
◦ Commercialization activities are encouraged per Policy
◦ Can not inhibit open research
◦ Research should result in generation and dissemination
of new knowledge
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Ethics
◦ Just the appearance of impropriety is to be avoided
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IRB – Human subjects
COI – Financial or other types of potential
conflicts of interest
HIPAA
ICD
IBC - recombinant DNA, infectious agents or
biologically derived toxins
AURPAC - ionizing radiation
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http://cflegacy.research.umn.edu/irb/about/
http://cflegacy.research.umn.edu/subjects/
http://cflegacy.research.umn.edu/irb/Scientif
icReview/index.cfm
www.umn.edu/regents/polindex.html
http://www.ospa.umn.edu/index.html
Questions:
Laura Williams, Principal Grant and Contract Administrator
[email protected]
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Estimating Personnel Time and Optimizing
Payment Terns
Debra Dykhuis
02.17.2009
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“…there are many ways of losing money.
Women are the most fun. Gambling is the
fastest. Research is the most certain.”
Lord Hives,
Former Chairman of Rolls Royce
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Quality of the data
Speed of accrual
Attention to compliance
Prospects of getting future research funding
Staff burnout/turnover
Jobs
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Have a clear clinical trial plan
Abandon the notion that guessing is the best
we can do
Abandon the notion that the sponsor, agency,
or center knows what it will cost to do the
trial (and has our best interests at heart)
Create a column for every time point data will
be collected
Create a row for every person who will have a
job to do
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Consider what each person will be required to
do for each visit and write it down
Attach an estimate of time to do each part of
the work
Ask the person who will be doing it what they
think of the estimate
Adjust as needed and enter the number of
hours required for each protocol time point
or visit
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Be sure to consider time staff will spend at
research meetings, on subject recruitment,
the time to prepare for research subject visits
and the follow-up that might be needed,
event reporting, managing interactions with
monitors, and data queries
For industry trials, include time for start-up
and close out, regulatory documents,
amendment processing, etc.
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Reviewed time data for 20 clinical trials
completed 2005-2007
Areas of cancer, solid organ transplant,
critical care, rare diseases
Average time per study visit for a research
coordinator – 11 hours
Average start-up time – 45 hours for
regulatory processes; 24 hours for clinical
research coordinator
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Approximately 35% of an employee’s
appointment time is consumed by
vacation/sick leave, breaks, and other work
that may not be directly related to a clinical
trial
Consider this when writing budgets that
require budgeting by FTEs
Example: a .5 research coordinator on a solid
organ transplant study will be able to manage
about 61 visits per year (at 11 hrs/visit)
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Start date: terms should allow payment for work as
soon as it starts
End date: should be “until all study work completed”
Start-up and close-out costs: should be nonrefundable, unrelated to subject enrollment, payable
on contract execution
Final payment: not more than 10% withheld
Payment frequency: no less than quarterly for work
performed
Items payable on invoice: limit these to items that will
truly be sporadic or unpredictable (not as a way of
making reimbursement conditional)
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Good Clinical Practice Protocol Template
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Clinical Trial Budget Template
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SPA Processes
Bridget Foss
02.17.2009
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This process allows SPA to negotiate the
Agreement while the department is completing
budget negotiations.
Expedited PRF Package Includes:
 Draft PRF signed by Principal Investigator
 Draft Budget
 Draft Protocol
 Agreement (if available)
* It is essential that a sponsor contact is
included on the PRF for this process to be
effective.
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Proposals, non-industry funded trials, and
industry funded trials after budget
negotiation require the following:
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Fully Routed PRF
Final Protocol
Negotiated Budget
TASCS Billing Grid
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Questions to Consider During
PRF Prep
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Is the trial investigator sponsored?
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Is the project an animal clinical trial or preclinical research?
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What is the appropriate F&A rate for this
particular project?
Industry Funded Clinical Trial: 26% TDC
Non-Industry Funded Clinical Trial: 51%
MTDC
Pre-Clinical Research: 51% MTDC
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Compliance requirements for Investigators:
 Approved REPA
 Completed RCR training (or approved
extension)
SPA also checks the RSPP database for human
subjects, animal subjects and/or IBC
approvals. Please note that the title used on
the PRF needs to match the protocol title
approved by RSPP.
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If costs are incurred prior to execution of the
agreement, an advance account should be
requested.
SPA attempts to insert language allowing preaward costs; however, all pre-award costs are
incurred at the department’s risk.
Departments often request advance account
in order to complete Fairview submissions.
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SPA reviews and negotiates the contract
language for conformity with University
policy, and works in consultation with the
Office of General Counsel, the Office of
Technology Commercialization, and the
Principal Investigator.
Problem clauses may include publication,
confidentiality, intellectual property, and
indemnification.
Negotiations take time!
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If expedited process is used, SPA will not
execute the agreement until it receives the
final PRF package.
Compliance issues need to be resolved prior
to execution and award set up.
Agreements are sent to the investigators for
final review and or approval prior to
University execution.
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Fixed price industry funded clinical trials are
set up in accordance with the University
procedure “Handling Industry Sponsored
Clinical Trial Research Agreements.”
Accounts are initially set up for $0. Dollars
are set up on the Project by Sponsored
Financial Reporting as funds are received. It
is the department’s responsibility to rebudget dollars into the appropriate accounts
based on the budget.
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Cost reimbursable awards and non-industry
funded trials are set up based on the
department provided and sponsor approved
budget for the current period.
Account set up, regardless of funding source,
is subject to the terms and conditions of the
agreement governing the project. Each
project is handled on a case by case basis.
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B&I Expedited Procedure:
http://www.ospa.umn.edu/policiesandprocedures/B&
Iclinicaltrials.html
F&A Rates:
http://www.ospa.umn.edu/forms/rates/F&A.html
Advance Account Policy:
http://www.fpd.finop.umn.edu/groups/ppd/docume
nts/policy/Preaward_Policy.cfm
Openness in Research policy:
http://www1.umn.edu/regents/policies/academic/O
penness_in_Research.pdf
Handling Industry-Sponsored Clinical Trial Research
Agreements:
http://www.fpd.finop.umn.edu/groups/ppd/docume
nts/procedure/clinical_trials_proc1.cfm
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