Transcript FH Legal CTA Presentation

Clinical Trial Agreements
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FLORIDA HOSPITAL
LEGAL DEPARTMENT
Outline: The best way to work with FH Legal
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 What is a Clinical Trial Agreement (CTA)?
 Why is it important to have a CTA?
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Sections contained in a typical CTA
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Challenges in negotiating a CTA
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Other types of Agreements
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Confidential Disclosure Agreement (CDA), Non-Disclosure Agreement (NDA)
Material Transfer Agreement (MTA)
Data Use Agreement (DUA)
 Who negotiates contracts for my department?
 When do I contact FH Legal?
 How do I work most effectively with FH Legal?
What is a Clinical Trial Agreement?
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A legally binding agreement that manages the
relationship between the Sponsor [typically Industry]
which may be providing:
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Study Drug or Device
Financial Support
Proprietary Information
And the Institution [Florida Hospital] which may be
providing:
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Data and/or Results
Publication, Input into Publication
Input into further Intellectual Property
Other Types of Agreements
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 Confidential Disclosure Agreements/
Non-Disclosure Agreements (CDA/NDA)
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Agreements to ensure confidentiality of proprietary data that the
Sponsor gives to Investigator in order to make a determination as to
whether or not s/he will participate in the trial/research.
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FH requires that FH be a party to all CDAs that will in any way
include FH.
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Depending on the circumstances, the CDA will either be between a
sponsor and FH, or sponsor, FH and principal investigator.
Why is it important to have a CTA?
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 Allocation of
 Risk
 Responsibility
 Money
 Obligations
 Protection of
 Rights (research, legal, intellectual property)
 Research Integrity
Sections contained in a
typical Clinical Trial Agreement
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 Preamble
 Acknowledgements &
Responsibilities
 Term & Termination
 Payment/Reimbursement of
Costs
 HIPAA, Patient Privacy
Publication
Intellectual Property
Confidentiality/
Proprietary Information
Indemnification
Insurance
Subject Injury
 Miscellaneous
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Governing Law
Notices
Assignment
 Exhibits
Negotiation
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 Sponsor supplies a
template.
 FH Legal reviews and
comments on the
document.
 Go back and forth with
sponsor until all points
are covered.
 Get to “Yes”.
Challenges in negotiating a CTA
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 Top 5 Hurdles
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Compliance with Florida Hospital policy
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Ability to terminate
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Indemnification
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Insurance
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If sponsor will not indemnify
If sponsor requires mutual indemnification
If sponsor does not carry minimum levels of insurance
If sponsor cannot prove liquid assets to cover liabilities
Publication
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If sponsor requires “approval” of publication
If sponsor a requires a de facto publication restriction
Uncle Sam wants You…..
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To Be Compliant.
Contract language must
be consistent with
Federal and state laws,
rules, regulations and
Florida Hospital policies,
requirements, and
procedures.
Indemnification
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 FH is a non-profit institution,
 Devoted to research and education.
 *FH will not incur liability on behalf of FH that is not
warranted by the normal course of our business.*
There are four specific points that FH requires it be
indemnified for in standard indemnification provisions:
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Any provision of services by Sponsor in connection with the study
FH’s participation in the study
Sponsor’s manufacturing defect of the study drug or device
Sponsor’s negligent use of data
Insurance
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 The Sponsor is responsible for the primary burden of risk,
therefore they are required to have minimum levels of insurance,
that are set by Risk Management at AHS, before FH is able to
participate in a study:
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$1 Million per Occurrence
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$3 Million in the Annual Aggregate
Less than the minimum levels
*REQUIRES RISK ASSESSMENT*
Publication
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 Scholarly publication is the fundamental right and responsibility
of researchers and FH. Sponsors may review manuscripts prior
to publication, but may not require terms that allow for
“approval” by the Sponsor.
Typical provisions:
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30 days for the removal of confidential information
Additional 60 days for the filing of patent applications.
Additional Challenges
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 If sponsor requires overreaching intellectual property clauses.
 If sponsor requires data/results to remain confidential or the
length of confidentiality is unreasonable.
 If sponsor will not agree to pay subject injury
reimbursements.
 If sponsor will not pay FH’s indirect cost rate of 25%.
Reading the CTA
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 A principal investigator’s responsibility in connection with a
CTA.
 While FH Legal reviews and negotiates agreements for the
research groups, it is very important that the principal
investigator review the agreement to ensure the s/he is
aware of the responsibilities required of him/her in
connection with a study and is in agreement with the
terms being agreed upon.
 The principal investigator is bound by the terms of the
agreement just as much as the hospital.
Who negotiates contracts for my department?
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FH Legal negotiates all contracts for all FH research
groups.
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FH Legal provides support to the ORA and the research groups
to understand the legal requirements and obligations of each
study. FH Legal works with the Sponsor in revising the
agreements, using as a basis previous contracts, templates and
master agreements with each sponsor.
When do I contact FH Legal?
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As soon as the sponsor contacts you about any
agreement, contact ORA. All requests for
contract reviews must come from ORA.
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Submit requests to ORA via IRBnet with the appropriate
documents.
How to “Pump Up” our Negotiating Standpoint.
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 United front.
 Clear layout of goals.
 Know who we are dealing
with.
 Understand the challenges.
How do I work most effectively with FH Legal?
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 Alert ORA ASAP
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Submit requests to ORA via IRBnet
 Communication is key
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Provide contact information for the
sponsor
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Continue to provide new information
you receive
How do I work most effectively with FH Legal?
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 Help us help you
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Agreement
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Protocol
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Budget
Thanks for Listening…
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