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Clinical Trial Agreements

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Presentation on theme: "Clinical Trial Agreements"— Presentation transcript:

1 Clinical Trial Agreements
Florida hospital Legal department This presentation is meant to describe and explain the negotiation process of clinical trial agreements with industry sponsors.

2 Outline: The best way to work with FH Legal
What is a Clinical Trial Agreement (CTA)? Why is it important to have a CTA? Sections contained in a typical CTA Challenges in negotiating a CTA Other types of Agreements 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? This helps explain the best way to work with FH Legal.

3 What is a Clinical Trial Agreement?
A legally binding agreement that manages the relationship between the Sponsor [typically Industry] which may be providing: Study Drug or Device Financial Support Proprietary Information And the Institution [Florida Hospital] which may be providing: Data and/or Results Publication, Input into Publication Input into further Intellectual Property A CTA is the document that governs and delineates the terms and obligations of your relationship with the Sponsor. This is also the document that will be most influential towards affecting the outcome of any legal disputes between the participating parties.

4 Other Types of Agreements
Confidential Disclosure Agreements/ Non-Disclosure Agreements (CDA/NDA) 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. FH requires that FH be a party to all CDAs that will in any way include FH. Depending on the circumstances, the CDA will either be between a sponsor and FH, or sponsor, FH and principal investigator. Typically, sponsors will send over a confidential disclosure agreement, (a CDA or NDA as they are commonly referred to) as a preliminary means of evaluating a site’s interest in participating in a trial. Most of the time these documents are sent directly to the PI or PI’s office with instructions to sign and return. PI’s are not authorized to sign on behalf of FH. DO NOT BE FOOLED! These documents must be reviewed by FH Legal, and they typically require some negotiation on the language and obligations that are contained in the agreement. After all, sponsors are always going to try and vigorously protect their confidential and proprietary information, and breaches of these agreements could potentially result in devastating lawsuits. We review these documents to make sure that the commitments required by the Sponsor are reasonable and practical.

5 Why is it important to have a CTA?
Allocation of Risk Responsibility Money Obligations Protection of Rights (research, legal, intellectual property) Research Integrity Now, to get into the ‘Meat and Potatoes’ of contracting. The first question? Why do we need to have a contract? Because the conduct of clinical research in human subjects carries a great deal of risk for a medical institution. The contract is the document that protects your intellectual, research, and legal rights, and lays out the financial, regulatory, and legal obligations of the parties involved. Ultimately, your responsibility as researchers is to protect the integrity of FH, and the contract provides us with the best opportunity to do so before we even enroll a patient.

6 Sections contained in a typical Clinical Trial Agreement
Preamble Acknowledgements & Responsibilities Term & Termination Payment/Reimbursement of Costs HIPAA, Patient Privacy Publication Intellectual Property Confidentiality/ Proprietary Information Indemnification Insurance Subject Injury Miscellaneous Governing Law Notices Assignment Exhibits Here is a thorough listing of the clauses generally contained in a typical clinical trial agreement.

7 Negotiation 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”. This slide contains an extremely basic description of the negotiation process. TEMPLATE < DRAFT < REPLY < RESPONSE < YES!! Although this picture makes it seem as though these two gentlemen are at odds with one another, it is important to remember that all of the parties involved share a common goal from which we draw different rewards. The Sponsor is ultimately investing in the potential of a an experimental product, so it is in their best interests to control the flow of information as much as possible in order to obtain the most commercially acceptable results. FH is ultimately participating in the trial to help further progress the world’s understanding and knowledge of medical science, so it is in our best interests to make sure that information generated by conducting research is shared so that other researchers can learn from our experience.

8 Challenges in negotiating a CTA
Top 5 Hurdles Compliance with Florida Hospital policy Ability to terminate Indemnification If sponsor will not indemnify If sponsor requires mutual indemnification Insurance If sponsor does not carry minimum levels of insurance If sponsor cannot prove liquid assets to cover liabilities Publication If sponsor requires “approval” of publication If sponsor a requires a de facto publication restriction In a perfect world, the Sponsor and FH have a clear understanding of the goals of each party, and negotiations can move along rapidly, with little or no contentious debate. However, the reality of the situation is that sponsors typically feign ignorance when it comes to understanding the biggest obstacles faced by medical institutions. More often then not, sponsors frequently employ an “It never hurts to ask” method of negotiation. This slide contains a brief listing of the top five ‘Show Stopping’ issues that many contracts face before signature.

9 Uncle Sam wants You….. To Be Compliant. Contract language must be consistent with Federal and state laws, rules, regulations and Florida Hospital policies, requirements, and procedures. Let us begin by first discussing a very important topic, consistency with applicable laws and regulations. The slide is fairly self-explanatory, -we cannot agree to do anything illegal, -we cannot agree to do anything that is adverse to our research mission -we cannot agree to any language that is inconsistent with our Bylaws. So to reiterate, every contract must be compliant with Federal and state laws, rules and regulations and FH policies, requirements and procedures. This also means that we must agree to language that is realistic. If a sponsor provides language that states that all research personnel shall not work on any trials or projects that relate to the medical condition, then we can not realistically comply with this request. We will not confer power on an outside entity to tell us what we can and cannot study.

10 Indemnification There are four specific points that FH requires it be
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: 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 This next big, scary word carries an even scarier level of importance. Currently there is a law on the books in 38 states that prevents the reimbursement or recouping of legal fees. The indemnification section of the contract essentially allows us to recover these costs. Frequently, sponsors request that FH indemnify the Sponsor and its affiliates for any possible lawsuits resulting from the negligence of an FH employee in connection with the study. This poses a problem for us because FH will not indemnify an industrial sponsor, conversely, FH will not enter into a contract without an indemnification from the Sponsor. Not only do we need indemnification, we need a strong indemnification. This is common practice among our fellow medical centers, and it represents the fair and proper allocation of risk. It is also an issue that FH will not compromise on. I ask that you keep in mind that global consumers spent $837 billion dollars on pharmaceutical drugs in 2009, so the risk/reward ratio clearly benefits the sponsor. The next topic ties in directly with indemnification.

11 Insurance 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: $1 Million per Occurrence $3 Million in the Annual Aggregate Less than the minimum levels *REQUIRES RISK ASSESSMENT* It is extremely important that industrial sponsors have the resources necessary to support clinical trial contract obligations. If the Sponsor has coverage limits that are less than the $1M and $3M required by AHS, then a risk assessment must be conducted on the protocol, which will then be combined with an evaluation of the Sponsor’s assets and financial situation. If the results of these assessments are unfavorable, and the risks outweigh the coverage, then FH may choose not to participate in the trial. Please note that many prominent pharmaceutical/biotech companies have plenty of insurance. The smaller, startup pharmaceutical/biotech companies may have less insurance than we require. This does not automatically mean that we cannot work with them, it just means that the study must be given a great deal of careful consideration before we can decide to participate. Here’s an example from Cornell University. Cornell University entered into an agreement with a Danish company that was only offering 5M Danish Krones worth of insurance coverage. A financial evaluation revealed that the company reported a net loss of over $16 Million in the first quarter. This company had to take out an additional insurance policy to comply with Cornell’s requirements. Obviously, FH needed to take a long look at participating in studies being conducted by sponsors in risky financial positions. Ultimately, the decision to participate lies with Sr. Management level officials here at FH.

12 Publication 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: 30 days for the removal of confidential information Additional 60 days for the filing of patent applications. In the summer of 2004, Attorney General Elliot Spitzer filed a lawsuit against GlaxoSmithKline for allegedly suppressing the “commercially unacceptable” results of four clinical studies on the effectiveness of Paxil in treating depression in adolescents. Regardless of the outcome, it is pretty telling that GSK established a registry to list all of the results of all of GSK’s clinical trials. This means that if left unchecked, sponsors will make every attempt to prevent the publication of results without the Sponsor’s written approval of the content. This represents a dire threat to our research mission and our overall research integrity. Even if an investigator is not going to publish, it is still FH’s fundamental right and responsibility to freely disseminate the results of clinical research. In other words, no one can restrict our academic right to publish, and any attempts to limit this right or censor the results are vigorously negotiated and vehemently defended. So the $64 thousand question is….When can we publish? Generally we cannot publish until after a multi-center publication has been released or twelve months after the completion of the study at all sites, whichever occurs first. Thereafter all manuscripts must be submitted at least 90 days before publication date. This grants the Sponsor the limited right to review and request the removal of confidential and proprietary information.

13 Additional Challenges
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%.

14 Reading the CTA 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. 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. FH Legal does not negotiate contracts for the principal investigator, its does so for the institution.

15 Who negotiates contracts for my department?
FH Legal negotiates all contracts for all FH research groups. 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. FH Legal is here to support, assist, and guide ORA and the research groups through the arduous task of coming to an agreement with a sponsor, complying with institutional guidelines, and protecting your research and financial interests.

16 When do I contact FH Legal?
As soon as the sponsor contacts you about any agreement, contact ORA. All requests for contract reviews must come from ORA. Submit requests to ORA via IRBnet with the appropriate documents. We are here to support, assist, and guide you through the arduous task of coming to an agreement with a sponsor, complying with FH guidelines, and protecting your research and financial interests.

17 How to “Pump Up” our Negotiating Standpoint.
United front. Clear layout of goals. Know who we are dealing with. Understand the challenges. Our primary responsibility at FH Legal is to serve, support, and protect FH and its employees. The most effective way to do this is to maintain a united front when dealing with the sponsor. We do not ever want to contradict each other, or be forced to correct each other in front of the sponsor. For instance, if an investigator communicates directly with a sponsor and subsequently agrees to an indirect cost rate that is less than 25%, it weakens FH’s negotiating standpoint making it much more difficult to obtain the rate set by FH. Clearly illustrate what your end goals are. – Publication in a certain time frame? Intellectual property rights? As long as we are informed, we will know which battles to fight. The personnel turnover rate at large companies is extremely high, and sometimes response time can seem interminably slow. For example, a representative from a prominent, global, house-hold name pharmaceutical company recently told me that it takes an average of 45 working days to respond to a revised draft. Not only is this at the extreme end of the spectrum, but it was also the third representative from that sponsor that I had to deal with on the same contract. Getting it right before the contract is signed will help prevent confusion and consequences later.

18 How do I work most effectively with FH Legal?
Alert ORA ASAP Submit requests to ORA via IRBnet Communication is key Provide contact information for the sponsor Continue to provide new information you receive Alert ORA through the IRBnet to any potential projects and agreements as soon as the investigator begins to consider participating. The more information you can provide to ORA, the better FH Legal can tailor the negotiations to the project. Communication is key, If you are ever unsure of the status of your project, check the status on IRBnet or ask ORA. ORA will be copied on all correspondence with the sponsor.

19 How do I work most effectively with FH Legal?
Help us help you Agreement Protocol Budget FH Legal cannot sign off on a contract unless all the required paperwork has been submitted and the file is complete. This includes the budget which is normally an exhibit to the contract. It is important that when a CTA is submitted to ORA for negotiations by FH Legal, the research group submit its budget with the CTA or shortly thereafter. Delays in submitting the budget can create delays with the sponsors. Past experiences have shown us that there are sponsors who will not review a CTA until they have received a budget. When a budget is not submitted, a sponsor may view it as a lack of urgency on a study and will simply place that CTA at the back of the line until they receive the budget. This ultimately creates lengthy delays in finalizing a CTA. This paperwork essentially allows us to comply with all of the rules and obligations that we are committing to in the contract.

20 Thanks for Listening… Hopefully this power point presentation has accurately described the challenges faced by every single agreement while illustrating the negotiation process. We are all on the same team, and the more we can understand each other’s roles and job functions, the better off we will be.

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