Why does it take so long to negotiate contract terms and language in CTA?
After required study documents are submitted to RMG CT Intake Team, your study will be assigned a Clinical Trail Contract Officer (CTCO) to negotiate the CTA terms and language.
Your CTRMG team takes a collaborative approach to negotiating CTAs. With this approach, a successful negotiation upholds Stanford policies, as a nonprofit educational institution, while also partnering with for-profit sponsors. This partnership is grounded on mutually acceptable terms within the CTA.
It is important to take time necessary to ensure that Stanford’s specific needs are addressed and when necessary to communicate with any third party parties involved in conducting the study. Sometimes an agreement on contractual terms between parties with such different fundamental organizational purposes requires escalation for final approval.
Stanford’s contract requirements differ between company-sponsored trials and investigator-initiated trials.
We take time to ensure we agree on the best possible agreement and strengthen our relationship with sponsor.
Whenever possible, we encourage sponsors to use the Accelerated Clinical Trials Agreement (ACTA), a Master Agreement with reasonable compromise language that was collaboratively developed by a working group of different stakeholders, including pharmaceutical companies, not-for-profit organizations, and academic research institutions. Use of this standardized agreement greatly expedites the contracting process.
Many industry sponsors prefer to use their own CTA template and when it does not comply with Stanford’s institutional requirements, negotiation on the contract’s terms and conditions is required.
Stanford currently has over 100 Master Agreements in place with pharmaceutical, device and biotechnology companies and use of these existing agreements also greatly expedites the negotiation process.
There are 6 key areas of concern that often require negotiation and may delay contract execution: intellectual property, study data, indemnification, subject injury, confidentiality, and publication rights. Reimbursement procedures are also often addressed within the contract terms.
Some investigational device studies require Stanford Hospital to negotiate a Purchase Agreement with the sponsor. Please refer to hospital website link in Resources section for the online form to initiate this agreement.
How to work with your CTCO to support contract negotiation process
Reach out at any time to the CTCO assigned to your study. Your scheduled KO meeting is an ideal time to bring up any questions you may have regarding the CTA. If not yet determined, at this meeting the CTCO will confirm the following details:
- Was PI involved in writing the protocol?
- Will any intellectual property arise from conducting the study?
- Does the PI have any financial disclosures to be considered?
Who signs the CTA?
Principal Investigator as Signatory. As a PI, you are not party to the CTA since you will be performing the agreement solely in your capacity as a Stanford employee. However, PIs sign the CTA to attest that they have read and understood its terms and their obligations and responsibilities. A PI does not have authority to sign a CTA on behalf of Stanford.
Key CTA Negotiation Hot Points:
1. Intellectual Property (IP) Rights
IP Rights refer to patents and other intellectual property rights in inventions. Stanford does not include copyrights in the category of IP rights that may be assigned to sponsors by CTA. While Stanford employees are required to assign rights to patentable inventions to the university all rights in copyright remain with the creator and thus, Stanford cannot assign to sponsor rights that it does not have.
2. Study Data
CTA should include terms to allow PI
- access to final study data and analysis for data from all sites
- retain a copy of Stanford generated data to document the research & provide patient care
- to publish Stanford data
When a sponsor- initiated study involves a drug or device, the sponsor must indemnify, defend and hold harmless all Stanford affiliated parties from and against all claims, liability, damage, loss or expense arising from conducting the study that are not due to Stanford’s negligence or willful failure to follow the protocol.
For example, sponsor must cover claims arising from subject injury or illness caused by the investigational product according to the protocol. Also, claims from the sponsor’s use of study data and any IP rights granted to the sponsor must be covered. For investigator-initiated studies, the sponsor’s liability for these claims is restricted to areas the sponsor is responsible for (e.g. manufacture of the product or use of study data).
4. Subject Injury
When a sponsor- initiated study involves a drug or device, the sponsor must agree to provide funding to cover medical care costs for any study related injury or illness. As a general policy, the sponsor’s subject injury obligation should cover a subject’s medical care costs regardless of whether these costs are covered by the subject’s insurance. Stanford does not agree to bill a subject’s insurance for injuries sustained in connection with an industry-sponsored clinical trial.
For investigator-initiated studies (IIS), Stanford will cover subject injury medical costs and the CTAs are reviewed by Stanford’s Risk Assessment Committee (RAC) so that the financial risk to Stanford may be assessed. If the risk is determined to be too high, RAC may not allow study to proceed.
5. Sponsor’s Confidential Information
Sponsors may require confidentiality of sponsor-provided information and study terms and may request that the data generated by the study be treated as confidential information for purposes other than academic publication. Due to Stanford’s openness in research policies, neither the existence of the CTA nor the identity of the study may be confidential. Stanford should have the right to disclose the confidential information as needed, to review, conduct and oversee the study, to adhere to applicable regulations and to assure appropriate medical care of study subjects.
6. Publication Rights
As an educational and research institution, Stanford’s basic mission is the discovery and publication of new ideas and technologies. CTA must provide for the right to publish and present research results. As part of Stanford’s commitment to openness in research, Stanford does not agree to let sponsors keep study results confidential, prevent their publication, or “hide” bad results.
Other Contractual Requirements that may be Problematic
Sponsors are expected to maintain, through study period and for a reasonable period after study has ended, a level of insurance (defined by Stanford IRB’s determined risk level of the study) to cover their financial obligations under the CTA.
Use of Stanford Name:
Sponsor must agree not to use Stanford name or logo in press releases, marketing or any other promotional documents without Stanford’s prior review and written approval.
Restrictions to conducting research:
CTA may not restrict Stanford from engaging in other research. For example, with the assumption that this is clearly discussed in the informed consent, investigators should be able to collect, retain and use tissue specimens from study subjects for research unrelated to the study and the investigational drug or device being tested.