The Clinical Trials Office (CTO) facilitates clinical research by providing the USC researcher community with comprehensive administrative services that help move industry-sponsored clinical trials quickly from initial concept to study completion. The CTO provides budget development, Medicare Coverage Analysis (MCA), contract negotiation and execution for industry-sponsored clinical trials, in addition to performing the MCA for non-industry sponsored clinical trials.
CTO provides the below administrative services for industry-sponsored clinical trials. Industry-sponsored clinical trials are any research activity that involves a drug, device, or biologic, (test article) subject to prior submission to the FDA as part of an application for a research or marketing permit or is not subject to prior submission but is intended to be submitted later as part of an application for a research or marketing permit. Clinical trials are designed to determine efficacy and safety of the test article.
Budget Development and Negotiation
The CTO provides budget development and negotiation services for clinical trials funded by industry. A successful clinical trial will include a budget that adequately meets the financial needs for all activities required to conduct the clinical trial. The CTO will work with the PI and/or Research Coordinator to ensure that the amount agreed upon by the Sponsor will adequately cover all costs associated with conducting a clinical trial. All industry-sponsored clinical trials are assess the Industry Clinical Trial indirect cost rate of 35% Total Direct Cost (excluding certain fees). All final budgets will be approved and signed by the PI and Department Chair/Center Director, or designee.
Medicare Coverage Analysis (MCA)
- Industry Sponsored Clinical Research Projects
The CTO provides the MCA for clinical trials funded by both industry and non-industry sponsors, as well as internally sponsored clinical studies and trials.
An MCA determines whether a clinical trial meets the requirements for reimbursement by Medicare or other insurers for routine care costs. The MCA also determines a priori which items or services will be charged to a third party and which items will be charged to the research study. MCAs are required for all clinical research studies in which some items or services will be billed to a third party as part of standard medical care, whether the third party is Medicare or another provider. The MCA must be completed for such studies prior to contracting and prior to enrollment of study participants. Diagnostic or therapeutic patient care costs of a clinical trial include:
- Items or services that are typically provided absent a clinical trial (e.g., conventional care)
- Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-approved chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
- Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service – in particular, for the diagnosis or treatment of complications.
Clinical studies and trials in which all charges are billed to the research project do not require an MCA. In such cases, all charges will be billed to the research project and none can be billed to third party payers.
- Non-Industry Sponsored Clinical Research Projects with Patient Care
Non-industry sponsored clinical research projects are negotiated and executed by the Department of Contracts and Grants (DCG), Health Sciences Campus.
Currently, every clinical project, regardless of sponsor, involving patient care must be submitted to CTO for a Medical Coverage Analysis (MCA; see below). Once the MCA is completed, costs for clinical procedures and labs chargeable to award/sponsor are identified and attached to the completed MCA. CTO also conducts a consistency review with the approved Informed Consent Form (ICF) from the IRB to make sure that terms included in ICF with respect to payments and subject injury are consistent with the grant or contract terms accepted by the University.
- Confidentiality Disclosure Agreements (CDA) for Industry-Sponsored Clinical Trials
Clinical trial sponsors may require that the PI and/or study staff sign a Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) before reviewing confidential documents, such as the Investigator Brochure, Protocol, and other non-public or proprietary information, to evaluate USC’s interest in conducting the clinical trial. CDAs and NDAs assure that the sponsor that the institution will protect the confidential information against unauthorized disclosure for a period of time. The PI may acknowledge her or his responsibilities under the CDA, but only the CTO can execute the CDA on behalf of the University.
- Industry Sponsored Drug or Device Agreements
These are instances where a sponsor provides a drug or device for a clinical trial, without funding from the sponsor. The agreement providing the drug or device will often have the same terms and conditions as sponsor-initiated clinical trial agreements (CTA).
The source of funding must be identified by the PI, department and/or School and the CTO will work with them to ensure resources are sufficient to conduct the trial, and to ensure compliance with regulations related to use of federal funds or other restricted funds.
- Clinical Trial Agreements
CTO is responsible for reviewing, negotiating and legally executing clinical trial agreements funded by for-profit private sponsors, such as pharmaceutical companies. Principal Investigators should discuss all aspects of the clinical trial with their Contracts Manager prior to the start of negotiations.