Introduction to Clinical Trials
The general steps involved with starting up a clinical trial are summarized here. Visit the MCW Clinical Trials Office (CTO) to learn about research support services for Investigators and Coordinators. For information on clinical trials pertaining to cancer, please visit the Cancer Center Clinical Trials Office website for information on available services and support for interventional cancer trials. If your clinical trial requires any resource (i.e. staff support, supplies, equipment, protected health information (PHI), etc.) from a Froedtert Health entity (e.g. Froedtert Hospital, Froedtert Menomonee Falls Hospital, Froedtert West Bend Hospital (or any Froedtert Hospital Clinic), researchers must connect with the Froedtert Hospital Office of Clinical Research Innovative Care Compliance (OCRICC) to facilitate collaboration with the Froedtert Hospital Leader.
Clinical Trials Step-by-Step
Before you can fully commit to a research project, feasibility must be assessed. Determine the logistics needed within your own MCW department and others, such as Radiology, Cardiology, Wisconsin Diagnostic Laboratories, etc. The following questions should be considered as part of the assessment process:
- Does your department/clinic have the qualified staff, equipment, and time to run the trial?
- Do you need/have a clinical research coordinator or assistant?
- Do you need procedural and professional services?
- Do you need translation services (PDF)?
- Do you have a qualified staff member to do the IRB submission?
- Who will do the data entry and fill out the case report forms?
- How will you recruit subjects?
- Will Froedtert departments/resources be necessary for the trial?
- Does your protocol require CT or MRI scans?
- PET scans?
- Blood Draws?
Feasibility issues involving resources requested of Froedtert Hospital departments must go through OCRICC. Feasibility not assessed via OCRICC will not be honored by Froedtert Hospital. Sponsor surveys of any kind that address Froedtert Hospital resources/equipment must be facilitated through OCRICC.
Applications for funding are submitted via eBridge in the form of a Funding Proposal which are routed through the Grants & Contracts Office (GCO).
Final budgets are negotiated by the department or investigator, not the GCO.
Your study will not be IRB approved until funding is awarded. There are sources of support to assist you with the submission process:
- eBridge Training for Funding Proposals offered by Research Systems Training
- Many departments have individuals assigned for budget/contract duties
Adequate funding is needed for every clinical trial. Sponsored clinical trials include funding. However, if you are opening an investigator initiated trial, you will likely need to obtain funding to support the trial. Therefore, it is important to assess the cost of running a trial and seek adequate funding. We recommend visiting the Finding Funding section in Research Resources for current opportunities, links to funding agencies, and resources available to assist you in your search for funding.
Protocols can come from various sources. Investigators can develop or draft their own protocols or they can pursue the option of becoming a local PI on a regional, national, or global trial. Pharmaceutical companies, Cooperative groups, and Clinical Trial Consortiums are all avenues by which clinical trials can be opened locally at MCW.
You must receive IRB approval prior to beginning any research activities. Your study may also require prior approval from ancillary committees, depending on the nature of the research to be conducted: e.g. Radiation Safety Committee, Institutional Biosafety Committee, MRI Safety Committee.
The approval process is conducted via eBridge, the College’s online mechanism for submitting protocols. Your department may have a designated person or persons who can assist you in completing the eBridge IRB application, known as a SmartForm. Research Systems Training also has services for assisting you with your submission process.
We recommend reviewing Working with Human Subjects within the FAQ section of Research Resources. Also available is information on how to obtain approval for Working with Radioactive Material, Working with MRIs, Working with Biologicals, etc.
OCRICC (Office of Clinical Research and Innovative Care Compliance)
Clinical trials that utilize any Froedtert Hospital resources - staff, facilities, equipment, etc. - in one way or another, must be reviewed via OCRICC to ensure that Froedtert Hospital has the staff, equipment, and other resources to successfully support the trial. OCRICC facilitates collaboration with Froedtert Hospital leaders for researchers to receive a commitment of these requests for the research. Following notification of MCW/Froedtert Hospital IRB Approval, OCRICC provides a Froedtert Hospital Administrative Approval for your protocol before researchers can consent any patient. Submitting your project’s OCRICC application at the same time as the IRB submission will facilitate the Froedtert Hospital administrative approval, and will typically follow notification of MCW/Froedtert Hospital IRB approval within an average of 3 business days.
Departments often have their own committees that review clinical trials prior to making a final decision about opening them, such as a Scientific Review Committee, Faculty Disease Group, Data Safety Monitoring Committee, etc. Sometimes the review group consists of formally appointed members; other times the trial must simply be discussed among other physicians within the department. Consult with your department Administrator or colleagues within your department to learn what steps to take for departmental review.
If you decide to open a trial through industry, you most likely will need to complete a Confidentiality Disclosure Agreement (CDA) before the sponsor will release the protocol document to you and your staff.
The CDA should always pass through the Grants & Contracts Office (intranet access required) to ensure the language is appropriate for the investigator to sign; often, the language requires some level of editing before signature.
The Medical College of Wisconsin maintains a corporate policy Contract Requirements for Sponsored Human Research (RS.GC.040) which is available on the College’s intranet site. If you have access to InfoScope, review this policy by searching for keywords “contract requirements” and select the link to this policy.