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Points to consider in drafting and negotiating a clinical trial agreement

Sandra Londono (sandra.londono@mssm.edu) is a Senior Contracts Specialist at Icahn School of Medicine at Mount Sinai in New York City. Pedram Alaedini (pedram.alaedini@primapax.com) is President and CEO of Primapax Group in Princeton, NJ.

Clinical trials are research-based studies that are performed to determine whether a drug, device, or medical procedure (depending on the stage of the study) is safe and effective. A complete set of clinical trials that includes all phases may cost hundreds of millions of dollars, which is usually paid for by a sponsor such as a government agency or a for-profit company. Increasingly, clinical trial activities are contracted out to a service provider such as an academic medical center (AMC), a contract research organization (CRO), or a physician’s practice, and this outsourcing requires negotiation and execution of a clinical trial agreement (CTA). Therefore, a CTA is required between the sponsor and the organization to conduct the clinical trial. This article will examine several critical points to consider when drafting and negotiating a CTA from the perspective of an AMC.

It is important to note that a CTA is essentially a document that governs the relationship between: (1) the sponsor that may be providing the study drug or device, the financial support, and proprietary information; and (2) the organization that will conduct the trial, provide the results, or further intellectual property. The CTA is crucial because it sets forth each party’s responsibilities with respect to the conduct of the study and identifies the deliverables. Thus, substantial time and effort may be necessary to draft and negotiate these types of agreements.

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