A clinical trial agreement (CTA) governs the relationship between the trial sponsor, who provides the device or drug to be studied along with the financial support to do so, and the research institution that will provide study data and results. A clinical trial is defined as a study using human subjects that is determined to question the efficacy of a particular behavior or biomedical intervention, such as a treatment, behavioral strategy, drug, medical device, or nutrition strategy.

The CTA is a legally binding document that governs the allocation of funds, risk, obligations, and responsibility, along with protecting each party's academic, legal, and ethical reputation and intellectual property (IP).

Elements of a CTA

Elements of a CTA include:

  • The terms of the collaboration.
  • The responsibilities of each party.
  • Payment and reimbursement procedures and requirements.
  • Intellectual property and publication terms.
  • Insurance and indemnification.
  • Coverage for subject injury.
  • Dispute resolution guidelines.
  • The procedure for amending contract terms.
  • The guidelines to terminate the contract.

In imaging and molecular diagnostics, a research study is considered a clinical trial when the information gathered from the test in question impacts medical decisions and thus has an impact on outcome. Studies that do not use data in this manner but are simply studying a new diagnostic approach are not considered clinical trials.

Behavioral clinical trials focus on interventions that aim to increase positive behaviors such as physical activity or cancer screenings, eliminate negative behaviors such as smoking, and/or improve quality of life for those with illness. Observational studies are not considered clinical trials.

While clinical research is usually conducted in a lab, clinical trials are typically done in a hospital setting. Clinical research is typically patient-oriented, such as studies of human disease mechanisms and the developments of new technologies and treatments related to disease.

Types of Agreements

A confidential disclosure agreement (CDA) details obligations surrounding the disclosure of confidential information and how this type of data will be safeguarded. Types of CDAs include:

  • Sponsor-initiated CDA, which is required before principal investigators (PI) receive confidential information such as a study protocol.
  • Mutual-disclosure CDA, used when sponsors and institutions exchange confidential information in the process of selecting a site for a clinical trial; this can include the conduct and design of the trial and information about the drug or device to be studied.
  • Investigator-initiated CDA, used when confidential information is disclosed to an academic or industry institution by the PI.

Types of CTAs can include:

  • CTA with an industry sponsor, which can be either investigator- or sponsor-initiated.
  • CTA with an academic institution, typically used for a subcontract or subaward when another site is brought in to assist with a clinical trial.

A data use agreement (DUA) is used when data is transferred in the absence of provisions included in a sponsored research agreement or CTA.

A service agreement is used when a PI is hired to perform a service that is not delineated in the CTA.

A registry agreement governs the informed consent of a patient to have their study data recorded in a registry database.

Master clinical trial agreements offer global terms and conditions within a particular institution.

Negotiating Clinical Trial Agreements

The investigator and the sponsoring company negotiate a budget and CTA for each clinical trial. When negotiating this type of contract, it's important to protect your reputation, negotiate strategically, and rely on your experience and expertise.

It's important to consider the rules of your institution, as public and non-profit educational and research institutions are bound by specific policies and regulations to protect the welfare of human subjects and minimize liability.

When non-profit organizations are partnering with for-profit companies, it's important to discern that ideals, goals, and principles are shared before proceeding. This might also require additional time for contract negotiations. It's important to ensure that acceptable contract clauses are developed for important issues that include indemnification, data and intellectual property ownership, patent and publication rights, confidentiality, and subject injury.

Many standard research institution contracts assume that the clinical trial is an FDA-regulated drug or medical device study, that the sponsor will provide product and study protocol, and that the cost will be fully funded by the sponsor.

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