Cancer Research Clinical Trials

Henry Ford Cancer offers a large number of clinical trials, which can offer new or developing treatments to patients before they are widely available. They also provide the opportunity to advance medical knowledge, prevent diseases and increase quality of life.

Henry Ford researchers place a strong emphasis on clinical research. That means that most of our work investigates how research questions affect patient care directly. However, our oncology researchers also conduct lab or bench research (studies performed in the laboratory, sometimes at the cellular level), investigating new treatments or cell behaviors.

Search for clinical trials available through Henry Ford for patients and families.

Clinical trials services for researchers

The Clinical Trials Office has the expertise to provide a centralized clinical research support system to researchers and clinicians throughout Henry Ford Health System. Our highly trained professionals monitor clinical trial processes and help clinical trials meet federal regulatory requirements.

Case management team

The Case Management Team consists of registered nurses who recruit, evaluate, obtain consent from and determine the eligibility of patients for clinical trial participation. The team:

• Ensures compliance and adverse event monitoring for patients throughout their participation in the clinical trial
• Maintains oversight of all patient care pertaining to a patient enrolled in a clinical trial
• Communicates consistently with the principal investigator regarding clinical trial patients

Data management team

The Data Management Team is responsible for abstracting data from CarePlus or other source documents onto the study-specific case report forms. The data manager will:

• Serve as an excellent double-check method in data documentation
• Seek clarification from the treatment nurse, case manager and/or principal investigator whenever there is a discrepancy. The Data Management Team does not make any clinical interpretation or judgment.
• Schedule and manage all study monitoring visits and/or external audits

Internal Review Board coordination

The internal review board coordinators are responsible for all aspects of Internal Review Board compliance, including:

• Completing appropriate paperwork
• Submitting new IRB applications
• Yearly renewals
• Amendments
• Revisions
• Final reports
• Safety reports
• Protocol deviations
• Serious adverse events
• Advertising and recruitment materials

Regulatory Maintenance Specialists

Regulatory Maintenance Specialists maintain compliance with federal regulatory requirements for clinical trials. These specialists will maintain the regulatory binder and handle all regulatory requests throughout the course of the study.

Regulatory Maintenance Specialists are responsible for submitting the initial regulatory packet to the sponsor, which includes:

• 1572 form
• CVs and licenses for the Principal Investigator and all Sub-Investigators
• Local laboratory CLIA and CAP
• Lab director's CV and license
• Delegation of authority log
• Signature log
• Other sponsor-specific regulatory requests

Pharmacokinetics and Central Lab Submission

This service provides for pickup and processing (such as centrifuging and pipetting) of any central lab submission or pharmacokinetics sample. Please note that this service cannot draw blood.

Pharmacokinetics and Central Lab Submission includes:

• Specimens: This service can store and/or ship specimens per protocol instructions and in compliance with hazardous materials shipping requirements.
• Lab supplies: Lab service can include management of study lab supplies (ordering, storing, and discarding of expired supplies).

Financial Management

The Financial Manager can provide:

• Study budget negotiation
• Grant start-up (opening a grant)
• Contract review for financial language considerations
• Ongoing management of the study grant
• Invoicing the sponsor
• Monitoring of grant expenses, such as patient care costs or check requests for patient stipends

Computer Programming and Database Design

This service can provide computer programming and/or database design for any clinical trial or departmental need. This service also can identify patient populations that meet defined criteria within the Henry Ford Health System Corporate Data Store (CDS).

Clinical trials expertise

Consultations are available at Henry Ford Hospital in Detroit for researchers who are preparing a proposal for the National Institutes of Health.

We offer consultation in the following areas

• Clinical trial design and generation of protocols
• Investigational New Drug (IND) applications
• FDA approval process
• Conduct of clinical trials

For information about clinical trials consultation, please contact Tiffany Pearce at Tpearce1@hfhs.org or (313) 916-1021.