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Obviously, Gillian Niher could not have brought Neurion’s materials to NIH under the MTA, because MTAs expressly prohibit using transferred materials in humans. To address this limitation in the MTA, some of the Institutes have developed a variant, which would permit them to use received materials for clinical purposes. The Clinical Trial Agreement is, at its heart, an expanded MTA. In addition to all the topics arising under the MTA, the CTA addresses other issues specific to clinical trials. A well crafted CTA should reflect, at a minimum, special consideration relating to protocol drafting, regulatory filings, interactions with regulatory agencies, use of data, and how the agreement might be terminated in the middle of the clinical trial without endangering the patients enrolled in the trial.
Because the provider does not have to participate in the research under a CTA, the CTA should make clear the provider’s role. Some providers are pleased to be passive, particularly those who have little or no experience in running clinical trials or interacting with the US Food & Drug Administration ("FDA"); other providers want at least an equal role as the NIH in drafting, reviewing, and approving any protocols, and in analyzing the data. NIH is flexible, provided that no outside party has the authority to command NIH personnel, restrict NIH research, or veto NIH publications.
Additionally, the CTA must clearly state who will be responsible for filing any regulatory documents with the FDA, such as an Investigational New Drug application ("IND"), necessary to enable the research to begin. Because INDs are expensive and complicated, companies often are happy to let NIH bear responsibility for filing the IND if the NIH is so inclined. If NIH is going to accept that responsibility, however, the provider should agree to send NIH the necessary formulation data -- or, at least, the provider must give NIH access to a Drug Master File.
As a matter of law, the holder of the IND is responsible for reporting adverse events, 34 and for participating in any direct interactions with the FDA. 35 When NIH holds the IND, some providers want to participate in this process, and some do not; the term is negotiable. If the provider holds the IND, however, the NIH must have the right to file its own adverse event reports, and must be permitted to participate in any meetings with the FDA. This is to ensure that information negatively affecting the product being tested will be timely disclosed to the FDA. Almost all companies would never suppress such data, but the temptation for a company, which may be depending on the success of the product, to put a misleading spin on damaging information can be enormous. Physicians who are participating in the trial have a legal duty to report adverse events; the failure to do so could lead to administrative, or even criminal, penalties. 36 Consequently, NIH would rather risk insulting a company, and insist on retaining this right.
Normally, a CTA will state that each party will share with the other all raw data generated under the clinical trial, provided the confidentiality of the patients in the study is adequately protected. Further, each party normally has the right to use the data for its own purposes (reserving to each party, of course, the right to file patents on the inventions of its own employees). The parties may, if they like, agree to publish jointly; however, the NIH will always reserve the right to publish independently if the provider declines to join in a particular publication.
Finally, some term should address what happens if one or both of the parties determines that the agreement should be terminated before the protocol has been fully carried out. As a matter of medical ethics, a doctor should not be forced to abandon a viable course of therapy already being administered to a patient due solely to a provider’s refusal to continue providing the therapeutic agent. On the other hand, providers do not want to be forced to continue squandering significant resources on a project they have determined will not be profitable. Fortunately, there are several mechanisms to protect both parties’ needs. For example, the provider could agree to provide enough agent at the beginning of the trial to supply the entire protocol. Alternatively, the provider could give NIH a license, plus information on the manufacture of the materials, to hire a contractor to make enough agent to complete the trial (if NIH cannot make the materials itself). The mechanism is negotiable, even if the principle is not.
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