An Introduction to Clinical Trial Agreements
The team at Lex Moderna has developed highly specialized expertise in drafting and negotiating Clinical Trial Agreements (CTAs), which outline the responsibilities of sponsors, sites, and researchers with respect to clinical trials. This is the first in a series of posts exploring some of the issues that arise in these kinds of complex contracts.
Confidentiality Agreements in CTAs Generally
This post focuses on confidentiality issues in the context of CTA agreements. Industry-sponsored clinical research by its very nature involves the exchange of sensitive information, including proprietary information relating to products or protocols being tested.
The Inherent Tension Between Sponsors and Sites/Researchers
Confidentiality provisions in CTA agreements are important both for the sponsor and the site/affiliated researchers.
The sponsor wants to protect its financial investments in developing and testing new products prior to market. Disclosure of information can have potentially dangerous effects on the sponsor—whether it be negative press, misappropriation, or comprised patent potential. Toward that end, the sponsor favors a broad definition of material covered by the confidentiality agreement and strict limits on the use of such information for as long as possible. This is particularly true in a Phase I study.
Sites and researchers understand the need for confidentiality but need sufficient flexibility to treat study subjects and, in many cases, promote academic freedom through publications and presentations. Accordingly, sites and researchers may seek a more limited scope and duration of “Confidential Information.”
Attorneys negotiating CTAs will need to find a balance between the competing interests of the sponsor on the one hand and the site and researchers (and any other stakeholders) on the other in crafting confidentiality provisions while understanding how to advocate for their clients’ interests.
Issues to Consider in Drafting CTA Confidentiality Provisions
“Confidential Information”—Any CTA must define what is considered “Confidential Information” under the agreement. Depending on the client’s interests and the particular clinical trial at hand, this definition can be broad or narrow. The contract also should provide that the terms of the CTA itself are confidential subject only to enumerated exceptions.
Who is Covered—CTAs must specify who is entitled to receive Confidential Information. In particular, the CTA should specify whether access to such information extends to a party’s parent company, affiliates, and employees, officers, representatives, agents, contractors, and directors who have a need to know for purposes of performance under the agreement.
Permitted Use—The CTA must specify the permitted use of or disclosure of confidential information. Agreements generally should make provision for the use or disclosure of confidential information by the site as necessary for the treatment of a study subject, to study subjects, and to prospective study subjects to the extent necessary or appropriate to secure informed consent.
Return or Destruction of “Confidential Information”—A CTA should provide for the return or destruction of covered information within a prescribe period of time following a specific event or series of events.
Let Us Help
If you are a party to a CTA, contact Lex Moderna to see how we can add value to your agreements and ensure that your CTAs protect your company’s interests.