A Clinical Trial Agreement (“CTA”) is a legally binding agreement that manages the relationship between an “institution” (typically a hospital, university or medical center) and a “sponsor” of a clinical trial. A well drafted CTA defines the scope of work and formalizes the understandings between the parties, including the legal and financial terms related to the conduct of the clinical trial.
In our capacity as legal advisors to institutions, we have identified several key challenges which arise when negotiating CTAs on their behalf. These challenges include: (a) balancing compliance with an institution’s internal policies in conjunction with the requirements of the CTA; (b) negotiating indemnification provisions; and (c) agreeing on mutually acceptable publication guidelines.
With respect to an institution’s internal compliance, it is important to have an open dialogue with your institutional clients about their policies and procedures before signing the CTA. Oftentimes, CTAs are “form” documents, so care should be taken when reviewing them to ensure that an institutional client can comply with the various reporting and record retention requirements typically set forth in these “form” CTAs. For example, a CTA could set forth a requirement that a participating institution keep records on-site for ten (10) years, while that institution’s internal policy only requires records be kept for seven (7) years. By discussing your institutional client’s internal policies and procedures in advance, you can identify potential discrepancies and either negotiate alternative terms with the sponsor or flag the issue to ensure your client’s future compliance.
Indemnification provisions are frequently challenging in negotiating CTAs. An indemnification provision provides protection to the parties of the CTA (and their employees) in the event a claim is filed by a third party alleging damages arising from a clinical trial. Oftentimes, CTAs will contain mutual indemnification provisions that will require the sponsor or the institution to indemnify the other party when it is not at fault. From the institution’s standpoint, it is important that the indemnification provisions are broad enough to provide that the sponsor will indemnify, defend and hold harmless the institution and their affiliates performing the clinical trial, including their Trustees, Directors, Officers, employees, agents and any Principal Investigators, from any and all claims arising from the conduct of the clinical trial that are not due to the institution’s gross negligence or willful misconduct.
Publication rights require balancing the institution’s (or the Principal Investigator’s) desire to publish about the clinical trial, against the sponsor’s need to limit publication to protect its intellectual property and competitive advantage in the marketplace. Oftentimes, the CTA will permit the institution to publish subject to the sponsor’s right of prior review and right to delay publication in the event the clinical trial involves multiple institutions. It is important to discuss with your institutional clients what their plans are for publication prior to executing a CTA. Institutions that plan to publish frequently will want to carefully negotiate the publication rights to ensure that their results can be published in a timely manner.
Provisions related to regulatory compliance, intellectual property, insurance, subject injury and regulatory compliance also pose challenges when negotiating CTAs. If you would like more information about the issues involved with negotiating CTAs, please contact Robert Lombardi or Denise Butler of the Mirick O’Connell Health Law Group.