Clinical trials are studies of the effectiveness and safety of drugs, devices or procedures for the treatment of health problems in humans or animals. Pharmaceutical or medical device companies conduct trials to develop new medical treatments that must first be approved by the FDA before they may be sold for use by patients.
Clinical Trials Categories
For the purposes of establishing an agreement, clinical trials will be categorized as follows:
- Sponsor Initiated – the protocol for the clinical trial has been written by the sponsor (a pharmaceutical or medical device company)
- Principal Investigator (PI) Initiated – the protocol was written by an investigator
Steps in Establishing a Clinical Trial
When a PI receives a request from a company to participate in a sponsor- initiated clinical trial, the PI should evaluate the materials provided by the sponsor to determine if it is feasible to perform the work at Ohio State.
The PI should consider many factors in determining whether a trial can be successfully conducted at Ohio State.
- subject population
- financial feasibility
- academic significance
If a PI decides to proceed with a trial, it will take the coordinated efforts of several offices to put an agreement in place. Offices may include:
- Clinical Trials Management Organization (CTMO) in the College of Medicine
- Clinical Trials Office (CTO) in the Comprehensive Cancer Center
- Ohio State Wexner Medical Center Research Billing Office
- Blue Buffalo Veterinary Clinical Trials Office (BBVTCO)
- Office of Sponsored Programs (OSP)
- Office of Responsible Research Practices (ORRP)
- Office of Innovation and Economic Development (if a sponsor requires a Confidential Disclosure Agreement (CDA) or Material Transfer Agreement (MTA); or if Ohio State intellectual property will be used)
Principal Investigators and/or the appropriate clinical trials management office should advise the Sponsored Program Officer responsible for the forthcoming project as early in the process as possible, provide a copy of the protocol and advise the SPO whether it was created by the sponsor or by an Ohio State investigator.
The ePA-005 must be signed electronically by the PI and all co-investigators named in the form. It is also signed by the departments and colleges involved. The form is completed online by the PI or a delegate and routed electronically.
All investigators named on the ePA-005 must have an up-to-date conflict of interest disclosure on file.
The PI also must ensure that no outstanding effort certifications exist.
Internal Budget Development
The PI (or CTMO/CTO/BBVCTO or department budget manager, if applicable) develops an internal budget for the trial based on the procedures outlined in the protocol. The internal budget is then compared to the budget offered by the sponsor. The PI or budget manager negotiates the budget directly with the sponsor. After the budget is negotiated, the final budget is sent to the Sponsored Program Officer for inclusion in the contract.
Institutional Review Board
After the appropriate IRB approves the protocol, the PI should send a copy of the approved informed consent form to the Sponsored Program Officer. The Sponsored Program Officer will ensure that the terms of the contract are congruent with the approved informed consent form.
Office of Sponsored Programs
The Sponsored Program Officer reviews the contract, protocol, informed consent form and negotiates acceptable terms. In addition to the customary terms and conditions of a research agreement, a clinical trial agreement will also address various regulatory compliance issues as well as those dealing with subject safety. The sponsor may also hire a clinical research organization (CRO) to manage their contractual process. As a result, negotiations can take additional time to reach mutually acceptable terms.
The PI and department may be asked to approve unusual terms, such as publication restrictions. After the contract and budget are finalized, the Sponsored Program Officer forwards the contract to the PI for review and signature. The PI returns the contract to the Sponsored Program Officer.
The Office of Sponsored Programs will sign the contract after all the following conditions are met:
- protocol and informed consent form are approved by the IRB
- ePA-005 is fully signed
- contract fully negotiated
- medicare assurance document sent to Research Billing Office, if required
- conflict of interest disclosure complete
- effort certifications are up-to-date
After the fully signed contract is returned to OSP, a grant number is assigned and sent to the PI and a copy of the agreement is uploaded to the PI Portal. The PI submits the OSP grant number to the Research Billing Office to obtain a research billing number for hospital-billed services.